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Supporting Family Caregivers With Technology for Dementia Home Care (FamTechCare)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02483520
Recruitment Status : Completed
First Posted : June 29, 2015
Results First Posted : November 13, 2020
Last Update Posted : November 13, 2020
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of Kansas Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Dementia
Intervention Behavioral: FamTechCare
Enrollment 189
Recruitment Details Site A participants were recruited by advertisements in local media, university email, and regional conferences for caregivers. Site B participants were primarily recruited through an Alzheimer Disease center, a memory care clinic, and community outreach activities.
Pre-assignment Details Caregiver-Person with Dementia (PWD) dyads were randomly assigned to the intervention (FamTechCare) group or the attention control group using a quarter-based blocking strategy with 1:1 allocation developed by the study statistician. Caregivers in multiple dyad homes were cluster randomized to the same group.
Arm/Group Title Intervention FamTechCare Control and Delayed FamTechCare
Hide Arm/Group Description

This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

Period Title: Overall Study
Started 92 97
Caregivers 50 56
Persons With Dementia 42 41
Completed 81 73
Not Completed 11 24
Reason Not Completed
Lost to Follow-up             3             4
Withdrawal by Subject             4             14
Hospitalized             2             3
Moved to LTC             2             3
Arm/Group Title Intervention FamTechCare Control and Delayed FamTechCare Total
Hide Arm/Group Description

This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

Total of all reporting groups
Overall Number of Baseline Participants 81 73 154
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Caregiver Number Analyzed 42 participants 41 participants 83 participants
<=18 years 0 0 0
Between 18 and 65 years 19 19 38
>=65 years 23 22 45
Persons with Dementia Number Analyzed 39 participants 32 participants 71 participants
<=18 years 0 0 0
Between 18 and 65 years 7 6 13
>=65 years 32 26 58
[1]
Measure Analysis Population Description: Caregivers and Persons with Dementia reported. Combined they equal total participants.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Caregiver Number Analyzed 42 participants 41 participants 83 participants
64.6  (12.2) 63.9  (13.7) 64.3  (12.9)
Persons with Dementia Number Analyzed 39 participants 32 participants 71 participants
75.5  (9.7) 75.9  (9.3) 75.7  (9.5)
[1]
Measure Analysis Population Description: Caregivers and Persons with Dementia reported. Combined they equal total participants.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Caregiver Number Analyzed 42 participants 41 participants 83 participants
Female
30
  71.4%
29
  70.7%
59
  71.1%
Male
12
  28.6%
12
  29.3%
24
  28.9%
Persons with Dementia Number Analyzed 39 participants 32 participants 71 participants
Female
15
  38.5%
14
  43.8%
29
  40.8%
Male
24
  61.5%
18
  56.3%
42
  59.2%
[1]
Measure Analysis Population Description: Caregivers and Persons with Dementia reported. Combined they equal total participants.
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Caregiver Number Analyzed 42 participants 41 participants 83 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
41
  97.6%
37
  90.2%
78
  94.0%
Unknown or Not Reported
1
   2.4%
4
   9.8%
5
   6.0%
Persons with Dementia Number Analyzed 39 participants 32 participants 71 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
38
  97.4%
29
  90.6%
67
  94.4%
Unknown or Not Reported
1
   2.6%
3
   9.4%
4
   5.6%
[1]
Measure Analysis Population Description: Caregivers and Persons with Dementia reported. Combined they equal total participants.
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Caregiver Number Analyzed 42 participants 41 participants 83 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
   9.5%
1
   2.4%
5
   6.0%
White
37
  88.1%
40
  97.6%
77
  92.8%
More than one race
1
   2.4%
0
   0.0%
1
   1.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Persons with Dementia Number Analyzed 39 participants 32 participants 71 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   5.1%
1
   3.1%
3
   4.2%
White
37
  94.9%
31
  96.9%
68
  95.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: Caregivers and Persons with Dementia reported. Combined they equal total participants.
Primary Dementia Diagnosis   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 32 participants 71 participants
Alzheimer's disease
21
  53.8%
16
  50.0%
37
  52.1%
Other diagnosed dementia
15
  38.5%
9
  28.1%
24
  33.8%
Unknown
3
   7.7%
7
  21.9%
10
  14.1%
[1]
Measure Analysis Population Description: Persons with Dementia
FAST Disability Category   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 32 participants 71 participants
Incipient dementia
0
   0.0%
1
   3.1%
1
   1.4%
Mild dementia
10
  25.6%
10
  31.3%
20
  28.2%
Moderate dementia
7
  17.9%
6
  18.8%
13
  18.3%
Moderately severe dementia
21
  53.8%
15
  46.9%
36
  50.7%
Severe dementia
1
   2.6%
0
   0.0%
1
   1.4%
[1]
Measure Analysis Population Description: Persons with Dementia
Number of Caregivers in Analysis   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 32 participants 71 participants
1 Caregiver
35
  89.7%
27
  84.4%
62
  87.3%
2 Caregivers
4
  10.3%
2
   6.3%
6
   8.5%
3 Caregivers
0
   0.0%
2
   6.3%
2
   2.8%
4 Caregivers
0
   0.0%
1
   3.1%
1
   1.4%
[1]
Measure Analysis Population Description: Persons with Dementia
Caregiver's Relationship to Person with Dementia   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 41 participants 83 participants
Spouse
29
  69.0%
26
  63.4%
55
  66.3%
Child/Spouse of child
12
  28.6%
15
  36.6%
27
  32.5%
Other
1
   2.4%
0
   0.0%
1
   1.2%
[1]
Measure Analysis Population Description: Caregivers
1.Primary Outcome
Title Change in Behaviorally Coded Challenging Behaviors (Agitated, Disruptive, Resistive)
Hide Description Behavioral coding of videos for agitated, disruptive, or resistive behaviors will be used to identity changes in behavior before and after the intervention.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Over 3 months, caregivers recorded videos during challenging care situations in order to receive feedback on interventions. Behavioral coding of the videos was not possible due to lack of consistent content post intervention. Caregivers failed to record follow-up videos of the care situations when they were no longer challenging.
Arm/Group Title Intervention FamTechCare Control and Delayed FamTechCare
Hide Arm/Group Description:

This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

Overall Number of Participants Analyzed 81 73
Measure Type: Number
Unit of Measure: Care videos submitted
784 253
2.Primary Outcome
Title Change in Caregiver Stress - Reaction to Memory Symptoms (Bother)
Hide Description Caregiver reaction to behavioral symptoms of the Person with Dementia (PWD) was measured by the Revised Memory and Problem Behavior Checklist (RMPBC). The RMPBC contains 24 items, each with two parts. Each item represents a behavior; if the behavior has been exhibited by the PWD in the past week, the caregiver reports the behavior as present. If the behavior is present, the caregiver then reports "how much it bothered you?" on a five-point Likert scale (0 = not at all; 4 = extremely). If the behavior was not present, no "bother" score is provided, and the item is scored 0. The items are summed for a total score (range = 0-96) and for three subscales representing bother due to memory-related problems (range = 0-28), depressive symptoms (range = 0-36), and disruptive symptoms (range = 0-32). A higher score indicates a greater negative reaction to behaviors.
Time Frame Baseline, 1 month, 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
One caregiver is missing from the control group due to missing data (missing at random).
Arm/Group Title Intervention FamTechCare Control and Delayed FamTechCare
Hide Arm/Group Description:

This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

Overall Number of Participants Analyzed 42 40
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 22.8  (15.6) 17.5  (11.8)
1 month 20.5  (14.3) 18.9  (13.0)
3 months 19.8  (15.3) 17.4  (12.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention FamTechCare, Control and Delayed FamTechCare
Comments Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .977
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM Estimate
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-2.02 to 2.08
Estimation Comments [Not Specified]
3.Primary Outcome
Title Change in Caregiver Stress - Reaction to Depressive Symptoms (Bother)
Hide Description Caregiver reaction to behavioral symptoms of the person with dementia (PWD) was measured by the Revised Memory and Problem Behavior Checklist (RMPBC). The RMPBC contains 24 items, each with two parts. Each item represents a behavior; if the behavior has been exhibited by the PWD in the past week, the caregiver reports the behavior as present. If the behavior is present, the caregiver then reports "how much it bothered you?" on a five-point Likert scale (0 = not at all; 4 = extremely). If the behavior was not present, no "bother" score is provided, and the item is scored 0. The items are summed for a total score (range = 0-96) and for three subscales representing bother due to memory-related problems (range = 0-28), depressive symptoms (range = 0-36), and disruptive symptoms (range = 0-32). A higher score indicates a greater negative reaction to behaviors.
Time Frame Baseline, 1 month, 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
One caregiver is missing from the control group due to missing data (missing at random).
Arm/Group Title Intervention FamTechCare Control and Delayed FamTechCare
Hide Arm/Group Description:

This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

Overall Number of Participants Analyzed 42 40
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 8.3  (7.3) 6.9  (6.8)
1 month 6.8  (7.6) 7.6  (6.9)
3 months 7.3  (7.0) 6.1  (6.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention FamTechCare, Control and Delayed FamTechCare
Comments Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .812
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM Estimate
Estimated Value -0.22
Confidence Interval (2-Sided) 95%
-2.09 to 1.64
Estimation Comments [Not Specified]
4.Primary Outcome
Title Change in Caregiver Stress - Desire to Instituionalize
Hide Description Desire to institutionalize was measured using a modified Desire to Institutionalize Scale. The modified Desire to Institutionalize Scale contains six items rated as dichotomous yes or no (1 = yes; 0 = no). A higher score indicates a greater desire to institutionalize (range = 0-6). Internal consistency for the Desire to Institutionalize scale is adequate (α = .69-.77) and has shown adequate construct validity through factor analysis.
Time Frame Baseline, 1 month, 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention FamTechCare Control and Delayed FamTechCare
Hide Arm/Group Description:

This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

Overall Number of Participants Analyzed 42 41
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 1.5  (1.7) 1.7  (1.5)
1 month 1.6  (1.7) 1.9  (2.1)
3 months 2.0  (2.0) 2.5  (2.3)
5.Primary Outcome
Title Change in Caregiver Stress - Biological Sensor Data
Hide Description Biological stress reactions measured by sensor
Time Frame Baseline, 1 month, 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Unable to collect information due to feasibility. Sensors were unreliable. Two different types of sensors were attempted.
Arm/Group Title Intervention FamTechCare Control and Delayed FamTechCare
Hide Arm/Group Description:

This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Primary Outcome
Title Change in Caregiver Burden
Hide Description Caregiver burden was measured using the Modified Zarit Burden Scale that contains 12 items with a 5-point Likert scale (0 = never; 4 = nearly always) adapted from the 22-item Zarit Burden Interview. A higher score indicates greater caregiver burden (range = 0-48). The Modified Zarit Burden Scale has shown adequate internal consistency (α = .88) and excellent concurrent validity (r = .92- .97) with the full Zarit Burden Interview.
Time Frame Baseline, 1 month, 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention FamTechCare Control and Delayed FamTechCare
Hide Arm/Group Description:

This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

Overall Number of Participants Analyzed 42 41
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 28.0  (10.6) 27.2  (8.1)
1 month 27.6  (9.9) 26.6  (8.5)
3 months 26.6  (9.8) 27.4  (9.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention FamTechCare, Control and Delayed FamTechCare
Comments Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .343
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM Estimate
Estimated Value -1.50
Confidence Interval (2-Sided) 95%
-4.64 to 1.64
Estimation Comments [Not Specified]
7.Primary Outcome
Title Change in Caregiver Health and Wellbeing - Depression
Hide Description Caregiver depression was measured using the Center for Epidemiologic Studies Depression scale (CES-D). The CES-D contains 20 items with a 4-point Likert scale ranging from 0 = rarely or none of the time (i.e., less than 1 day in past week) to 3 = most or all of the time (i.e., 5-7 days in past week). A higher score indicates greater depression (range = 0-60). The CES-D shows adequate internal consistency (α = .84-.90), moderate convergent validity with other depression scales (r = .44-.75), and has been shown to effectively measure change in psychoeducational interventions for dementia caregivers.
Time Frame Baseline, 1 month, 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention FamTechCare Control and Delayed FamTechCare
Hide Arm/Group Description:

This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

Overall Number of Participants Analyzed 42 41
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 16.0  (10.7) 12.0  (8.1)
1 month 14.5  (11.9) 12.8  (10.2)
3 months 13.8  (10.6) 12.3  (10.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention FamTechCare, Control and Delayed FamTechCare
Comments Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .012
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM Estimate
Estimated Value -4.79
Confidence Interval (2-Sided) 95%
-8.51 to -1.08
Estimation Comments [Not Specified]
8.Primary Outcome
Title Change in Caregiver Health and Wellbeing - Competence
Hide Description Caregiver sense of competence was measured using the Short Sense of Competence Questionnaire (SSCQ).37 The SSCQ contains seven negatively worded items (e.g., "I feel strained in my interaction with..."). Each item is rated on a five-point Likert scale and dichotomized to agree (i.e., agree very strongly, agree, neutral) or disagree (i.e., disagree or strongly disagree). The items where the caregiver disagreed are summed for the total score. A higher score indicates a higher sense of competence (range = 0-7). The SSCQ shows adequate internal consistency (α = .76) and concurrent validity with the original Sense of Competence Questionnaire (r = .88).
Time Frame Baseline, 1 month, 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention FamTechCare Control and Delayed FamTechCare
Hide Arm/Group Description:

This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

Overall Number of Participants Analyzed 42 41
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 3.7  (1.8) 3.9  (2.2)
1 month 4.0  (2.0) 3.8  (2.1)
3 months 4.1  (1.9) 3.5  (2.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention FamTechCare, Control and Delayed FamTechCare
Comments Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .033
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM Estimate
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.07 to 1.47
Estimation Comments [Not Specified]
9.Primary Outcome
Title Change in Caregiver Health and Wellbeing - Sleep Disturbance
Hide Description Caregiver sleep disturbance was measured by the Pittsburgh Sleep Quality Index (PSQI). The PSQI contains 19 items with a 4-point Likert scale across seven domains: sleep quality, sleep latency, sleep duration, habitual sleep ef- ficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. A higher global score indicates worse sleep quality (range = 0-21). The PSQI shows adequate internal consistency (α = .83) and adequate validity in differentiating patients with and without sleep disorders.
Time Frame Baseline, 1 month, 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention FamTechCare Control and Delayed FamTechCare
Hide Arm/Group Description:

This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

Overall Number of Participants Analyzed 42 41
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 7.5  (3.5) 7.0  (3.5)
1 month 7.3  (3.6) 6.9  (3.8)
3 months 7.3  (3.4) 6.8  (4.2)
10.Primary Outcome
Title Change in Caregiver Health and Wellbeing - Medication Use
Hide Description Caregivers taking PRN anxiolytics, hypnotics, or antipsychotic medication.
Time Frame Baseline, 1 month, 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
We used descriptive statistics to describe changes in caregiver medication use between groups.
Arm/Group Title Intervention FamTechCare Control and Delayed FamTechCare
Hide Arm/Group Description:

This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

Overall Number of Participants Analyzed 2 4
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline
1
  50.0%
1
  25.0%
1 month
2
 100.0%
3
  75.0%
3 months
1
  50.0%
3
  75.0%
11.Primary Outcome
Title Change in Caregiver Health and Wellbeing - Confidence in Managing BPSD
Hide Description Caregivers reported their three priority care challenges at baseline using the Caregiver Target Problems Questionnaire (Teri, McCurry, Logsdon, & Gibbons, 2005). The Caregiver Target Problems Questionnaire was adapted and used to identify caregiver priority care challenges for frequency, severity, and confidence at baseline and 3-months (Teri et al., 2005). Prior to group allocation, caregivers identified three priority care challenges and rated them on 5-point Likert scales: frequency of the challenge (0 = None to 4 = Daily or more often), severity of the challenge (0 = Trivial to 4 = Severe), and confidence in managing the challenge (0 = Unable to manage to 4 = Very confident). At the end of the 3-month trial, caregivers repeated their ratings of the baseline care challenges. Improvement was indicated increase in confidence from baseline to 3-months.
Time Frame Baseline, 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Six caregivers were missing data on this measure and were not used in the analysis.
Arm/Group Title Intervention FamTechCare Control and Delayed FamTechCare
Hide Arm/Group Description:

This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

Overall Number of Participants Analyzed 42 35
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 1.7  (1.1) 2.3  (1.0)
3 months 2.6  (1.1) 2.8  (1.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention FamTechCare, Control and Delayed FamTechCare
Comments p-values were calculated for differences between mean group changes using Wilcoxon rank-sum test at 3 months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .211
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intervention FamTechCare
Comments p-values were calculated for within- group changes using Wilcoxon signed-rank test between baseline and 3 months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
12.Primary Outcome
Title Change in Caregiver Health and Wellbeing - Confidence in Managing Disease Expectations
Hide Description Caregivers reported their three priority care challenges at baseline using the Caregiver Target Problems Questionnaire (Teri, McCurry, Logsdon, & Gibbons, 2005). The Caregiver Target Problems Questionnaire was adapted and used to identify caregiver priority care challenges for frequency, severity, and confidence at baseline and 3-months (Teri et al., 2005). Prior to group allocation, caregivers identified three priority care challenges and rated them on 5-point Likert scales: frequency of the challenge (0 = None to 4 = Daily or more often), severity of the challenge (0 = Trivial to 4 = Severe), and confidence in managing the challenge (0 = Unable to manage to 4 = Very confident). At the end of the 3-month trial, caregivers repeated their ratings of the baseline care challenges. Improvement was indicated increase in confidence from baseline to 3-months.
Time Frame Baseline, 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Twenty-three caregivers were missing data on this measure and were not used in the analysis.
Arm/Group Title Intervention FamTechCare Control and Delayed FamTechCare
Hide Arm/Group Description:

This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

Overall Number of Participants Analyzed 29 31
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 2.3  (0.9) 2.2  (1.0)
3 months 2.9  (1.2) 2.8  (0.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention FamTechCare, Control and Delayed FamTechCare
Comments p-values were calculated for differences between mean group changes using Wilcoxon rank-sum test at 3 months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .476
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intervention FamTechCare
Comments p-values were calculated for within- group changes using Wilcoxon signed-rank test between baseline and 3 months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .005
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
13.Primary Outcome
Title Change in Caregiver Health and Wellbeing - Confidence in Managing ADLs (Activities of Daily Living)
Hide Description Caregivers reported their three priority care challenges at baseline using the Caregiver Target Problems Questionnaire (Teri, McCurry, Logsdon, & Gibbons, 2005). The Caregiver Target Problems Questionnaire was adapted and used to identify caregiver priority care challenges for frequency, severity, and confidence at baseline and 3-months (Teri et al., 2005). Prior to group allocation, caregivers identified three priority care challenges and rated them on 5-point Likert scales: frequency of the challenge (0 = None to 4 = Daily or more often), severity of the challenge (0 = Trivial to 4 = Severe), and confidence in managing the challenge (0 = Unable to manage to 4 = Very confident). At the end of the 3-month trial, caregivers repeated their ratings of the baseline care challenges. Improvement was indicated increase in confidence from baseline to 3-months.
Time Frame Baseline, 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Forty-one caregivers were missing data on this measure and were not used in the analysis.
Arm/Group Title Intervention FamTechCare Control and Delayed FamTechCare
Hide Arm/Group Description:

This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

Overall Number of Participants Analyzed 18 24
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 2.3  (1.0) 2.2  (1.1)
3 months 2.8  (0.9) 2.6  (0.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention FamTechCare, Control and Delayed FamTechCare
Comments p-values were calculated for differences between mean group changes using Wilcoxon rank-sum test at 3 months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .677
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intervention FamTechCare
Comments p-values were calculated for within- group changes using Wilcoxon signed-rank test between baseline and 3 months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .020
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
14.Primary Outcome
Title Change in Caregiver Reported Challenging Behaviors - Reaction to Disruptive Symptoms (Bother)
Hide Description Caregiver reaction to behavioral symptoms of the PLWD was measured by the Revised Memory and Problem Behavior Checklist (RMPBC). The RMPBC contains 24 items, each with two parts. Each item represents a behavior; if the behavior has been exhibited by the PLWD in the past week, the caregiver reports the behavior as present. If the behavior is present, the caregiver then reports "how much it bothered you?" on a five-point Likert scale (0 = not at all; 4 = extremely). If the behavior was not present, no "bother" score is provided, and the item is scored 0. The items are summed for a total score (range = 0-96) and for three subscales representing bother due to memory-related problems (range = 0-28), depressive symptoms (range = 0-36), and disruptive symptoms (range = 0-32). A higher score indicates a greater negative reaction to behaviors.
Time Frame Baseline, 1 month, 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
One caregiver is missing from the control group due to missing data (missing at random).
Arm/Group Title Intervention FamTechCare Control and Delayed FamTechCare
Hide Arm/Group Description:

This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

Overall Number of Participants Analyzed 42 40
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 6.1  (5.7) 4.0  (4.2)
1 month 5.3  (4.7) 5.1  (4.9)
3 months 5.4  (5.4) 4.9  (5.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention FamTechCare, Control and Delayed FamTechCare
Comments Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .432
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM Estimate
Estimated Value -0.62
Confidence Interval (2-Sided) 95%
-2.18 to 0.94
Estimation Comments [Not Specified]
15.Primary Outcome
Title Change in Caregiver Reported Challenging Behaviors - Frequency of Disruptive Behaviors
Hide Description Frequency of disruptive behaviors measured by the Revised Memory and Problem Behavior Checklist (RMPBC). The RMPBC contains 24 items. Each item represents a behavior; if the behavior has been exhibited by the person with dementia in the past week, the caregiver reports the behavior as present. There are 8 disruptive behaviors questions. Range is 0-8. A decrease in disruptive behaviors is an improvement.
Time Frame Baseline, 1 month, 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention FamTechCare Control and Delayed FamTechCare
Hide Arm/Group Description:

This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

Overall Number of Participants Analyzed 42 41
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 2.40  (1.85) 1.88  (1.68)
1 month 2.45  (1.88) 2.39  (1.91)
3 months 2.40  (1.89) 2.29  (1.78)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention FamTechCare, Control and Delayed FamTechCare
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .255
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
16.Secondary Outcome
Title Cost for FamTechCare Treatment Compared to Control Group
Hide Description Process-based costing for the FamTechCare group compared to the control group. Costs reflect the total cost for the program per dyad per week.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
3 month cost
Arm/Group Title Intervention FamTechCare Control and Delayed FamTechCare
Hide Arm/Group Description:

This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

Overall Number of Participants Analyzed 81 73
Measure Type: Number
Unit of Measure: US Dollars/Dyad/Week
Video-monitoring unit 175.00 0
Expert Team 174.16 0
Interventionist feedback call 86.63 76.02
Video screening 65.69 7.54
Mail 49.22 0
Enrollment 30.37 0
17.Secondary Outcome
Title Cost for FamTechCare Treatment Compared to Control Group - ICER
Hide Description Incremental Cost-effectiveness Ratio (ICER) for Significant Primary Outcomes: Depression and Competence. Costs reflect the total cost for the program per dyad per week to achieve effect in each outcome.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
ICER by week
Arm/Group Title Intervention FamTechCare Control and Delayed FamTechCare
Hide Arm/Group Description:

This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

Overall Number of Participants Analyzed 81 0
Measure Type: Number
Unit of Measure: US Dollars/Dyad/Week
Depression 18.51
Competence 36.38
Time Frame Once a week for a total of 12 weeks
Adverse Event Reporting Description Adverse Event: Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research. Definition from January 2007 OHRP Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events.
 
Arm/Group Title Intervention FamTechCare Control and Delayed FamTechCare
Hide Arm/Group Description

This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations. The intervention is weekly individualized feedback based on video data (FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation. At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare).

FamTechCare: Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.

All-Cause Mortality
Intervention FamTechCare Control and Delayed FamTechCare
Affected / at Risk (%) Affected / at Risk (%)
Total   0/92 (0.00%)      0/97 (0.00%)    
Hide Serious Adverse Events
Intervention FamTechCare Control and Delayed FamTechCare
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/92 (0.00%)      1/97 (1.03%)    
Psychiatric disorders     
Attempted suicide  1 [1]  /92  1/97 (1.03%)  1
1
Term from vocabulary, OHRP Guidance
Indicates events were collected by systematic assessment
[1]
Deemed by the IRB not related to the study
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Intervention FamTechCare Control and Delayed FamTechCare
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/92 (0.00%)      0/97 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kristine Williams, RN, PhD, FNP-BC, FGSA, FAAN, E. Jean Hill Professor
Organization: University of Kansas School of Nursing
Phone: 913 588-1673
EMail: Kwilliams1@kumc.edu
Layout table for additonal information
Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02483520    
Other Study ID Numbers: STUDY00000053
R01NR014737 ( U.S. NIH Grant/Contract )
First Submitted: June 4, 2015
First Posted: June 29, 2015
Results First Submitted: July 30, 2020
Results First Posted: November 13, 2020
Last Update Posted: November 13, 2020