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Caring for the Caregiver Network

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: NCT03049501
Recruitment Status : Completed
First Posted : February 10, 2017
Results First Posted : June 25, 2019
Last Update Posted : June 25, 2019
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
David Loewenstein, University of Miami

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition Caregivers of Alzheimer's Disease or Memory Problem Patients
Interventions Behavioral: Caregiving condition
Behavioral: Nutrition condition
Enrollment 244
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Caregiving Condition Nutrition Condition
Hide Arm/Group Description

Participants will receive a computer tablet and have access to web-based skill building sessions, videos from experts, annotated resources and information and tips on caregiving-related topics

Caregiving condition

Participants will receive a computer tablet and have access to web-based training sessions on different topics related to nutrition

Nutrition condition

Period Title: Overall Study
Started 123 121
6 Month Follow up 107 91
12 Month Follow up 101 92
Completed 101 92
Not Completed 22 29
Arm/Group Title Caregiving Condition Nutrition Condition Total
Hide Arm/Group Description

Participants will receive a computer tablet and have access to web-based skill building sessions, videos from experts, annotated resources and information and tips on caregiving-related topics

Caregiving condition

Participants will receive a computer tablet and have access to web-based training sessions on different topics related to nutrition

Nutrition condition

Total of all reporting groups
Overall Number of Baseline Participants 123 121 244
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 123 participants 121 participants 244 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
68
  55.3%
82
  67.8%
150
  61.5%
>=65 years
55
  44.7%
39
  32.2%
94
  38.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 123 participants 121 participants 244 participants
Female
103
  83.7%
101
  83.5%
204
  83.6%
Male
20
  16.3%
20
  16.5%
40
  16.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 123 participants 121 participants 244 participants
Hispanic or Latino
55
  44.7%
54
  44.6%
109
  44.7%
Not Hispanic or Latino
68
  55.3%
67
  55.4%
135
  55.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 123 participants 121 participants 244 participants
American Indian or Alaska Native
0
   0.0%
1
   0.8%
1
   0.4%
Asian
1
   0.8%
0
   0.0%
1
   0.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
29
  23.6%
26
  21.5%
55
  22.5%
White
85
  69.1%
89
  73.6%
174
  71.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
8
   6.5%
5
   4.1%
13
   5.3%
1.Primary Outcome
Title Depression as Measured by Center for Epidemiologic Studies Depression Scale (CES-D)
Hide Description CES-D Scale ranges from 0 to 30 with higher scores indicating greater frequency of depressive symptoms.
Time Frame Baseline, 6-mth follow-up and 12-mth follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Follow up visits were not completed for all participants
Arm/Group Title Caregiving Condition Nutrition Condition
Hide Arm/Group Description:

Participants will receive a computer tablet and have access to web-based skill building sessions, videos from experts, annotated resources and information and tips on caregiving-related topics

Caregiving condition

Participants will receive a computer tablet and have access to web-based training sessions on different topics related to nutrition

Nutrition condition

Overall Number of Participants Analyzed 123 121
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 123 participants 121 participants
11.38  (7.02) 10.88  (5.79)
6 month follow up Number Analyzed 107 participants 91 participants
10.86  (6.63) 10.69  (6.23)
12 month follow up Number Analyzed 101 participants 92 participants
10.32  (7.18) 10.46  (6.25)
2.Primary Outcome
Title Caregiving Burden as Measured by Burden Inventory
Hide Description Higher score means greater level of caregiver burden. Range (0-44)
Time Frame Baseline, 6-mth follow-up and 12-mth follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Follow up visits were not completed for all participants
Arm/Group Title Caregiving Condition Nutrition Condition
Hide Arm/Group Description:

Participants will receive a computer tablet and have access to web-based skill building sessions, videos from experts, annotated resources and information and tips on caregiving-related topics

Caregiving condition

Participants will receive a computer tablet and have access to web-based training sessions on different topics related to nutrition

Nutrition condition

Overall Number of Participants Analyzed 123 121
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 123 participants 121 participants
18.52  (8.91) 19.66  (7.59)
6 month follow up Number Analyzed 107 participants 91 participants
16.89  (8.39) 18.23  (6.97)
12 month follow up Number Analyzed 101 participants 92 participants
16.08  (8.29) 17.66  (8.27)
3.Primary Outcome
Title Caregiver's Self Report of Self-care
Hide Description A 13 Item self care questionnaire is used to measure caregivers self care. Each item can be scored as 0,1,negative 3 or negative 4. The total score ranging from negative 52 to 13. Higher score means better in keeping medical obligations to him/herself.
Time Frame Baseline, 6-mth follow-up and 12-mth follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Follow up visits were not completed for all participants
Arm/Group Title Caregiving Condition Nutrition Condition
Hide Arm/Group Description:

Participants will receive a computer tablet and have access to web-based skill building sessions, videos from experts, annotated resources and information and tips on caregiving-related topics

Caregiving condition

Participants will receive a computer tablet and have access to web-based training sessions on different topics related to nutrition

Nutrition condition

Overall Number of Participants Analyzed 123 121
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 123 participants 121 participants
0.62  (0.18) 0.60  (0.17)
6 month follow up Number Analyzed 107 participants 91 participants
0.62  (0.18) 0.60  (0.17)
12 month follow up Number Analyzed 101 participants 92 participants
0.62  (0.20) 0.61  (0.17)
4.Primary Outcome
Title Caregiver's Self-report of Physical Health
Hide Description SF 12 Health Survey was used to measure physical health of the caregiver. Scores ranges from 0 to 35 with lower score means less limitation to physical health.
Time Frame Baseline, 6-mth follow-up and 12-mth follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Follow up visits were not completed for all participants
Arm/Group Title Caregiving Condition Nutrition Condition
Hide Arm/Group Description:

Participants will receive a computer tablet and have access to web-based skill building sessions, videos from experts, annotated resources and information and tips on caregiving-related topics

Caregiving condition

Participants will receive a computer tablet and have access to web-based training sessions on different topics related to nutrition

Nutrition condition

Overall Number of Participants Analyzed 123 121
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 123 participants 121 participants
2.71  (1.03) 2.75  (1.14)
6 month follow up Number Analyzed 107 participants 91 participants
2.89  (1.12) 2.51  (1.11)
12 month follow up Number Analyzed 101 participants 92 participants
2.76  (1.09) 2.67  (1.22)
5.Primary Outcome
Title Caregiver's Self-efficacy
Hide Description A 15 item Caregiver's self efficacy questionnaire will be used to assess caregiver's self-efficacy. The questionnaire score ranges from 0-1500 percent with a lower percentage score indicating less efficacy.
Time Frame Baseline, 6-mth follow-up and 12-mth follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Follow up visits were not completed for all participants
Arm/Group Title Caregiving Condition Nutrition Condition
Hide Arm/Group Description:

Participants will receive a computer tablet and have access to web-based skill building sessions, videos from experts, annotated resources and information and tips on caregiving-related topics

Caregiving condition

Participants will receive a computer tablet and have access to web-based training sessions on different topics related to nutrition

Nutrition condition

Overall Number of Participants Analyzed 123 121
Mean (Standard Deviation)
Unit of Measure: percentage of efficacy
Baseline Number Analyzed 123 participants 121 participants
925.21  (243.36) 936.65  (249.62)
6 month follow up Number Analyzed 107 participants 91 participants
971.43  (295.41) 964.15  (273.06)
12 month follow up Number Analyzed 101 participants 92 participants
999.65  (285.94) 1047.71  (225.14)
6.Primary Outcome
Title Positive Aspects of Caregiving
Hide Description An 11 item positive aspects of caregiving questionnaire was used to measure positive aspects of caregiving. Each item can be scored 0, 1, 2, 3, 4, negative 3 or negative 4. The total score ranging from negative 44 to 44. Higher score means more positive feelings towards caregiving.
Time Frame Baseline, 6-mth follow-up and 12-mth follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Follow up visits were not completed for all participants
Arm/Group Title Caregiving Condition Nutrition Condition
Hide Arm/Group Description:

Participants will receive a computer tablet and have access to web-based skill building sessions, videos from experts, annotated resources and information and tips on caregiving-related topics

Caregiving condition

Participants will receive a computer tablet and have access to web-based training sessions on different topics related to nutrition

Nutrition condition

Overall Number of Participants Analyzed 123 121
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 123 participants 121 participants
24.46  (8.49) 23.24  (8.83)
6 month follow up Number Analyzed 107 participants 91 participants
24.72  (8.34) 24.02  (8.54)
12 month follow up Number Analyzed 101 participants 92 participants
24.00  (9.60) 24.58  (8.54)
Time Frame [Not Specified]
Adverse Event Reporting Description Per protocol, adverse events will not be collected during the course of this study.
 
Arm/Group Title Caregiving Condition Nutrition Condition
Hide Arm/Group Description

Participants will receive a computer tablet and have access to web-based skill building sessions, videos from experts, annotated resources and information and tips on caregiving-related topics

Caregiving condition

Participants will receive a computer tablet and have access to web-based training sessions on different topics related to nutrition

Nutrition condition

All-Cause Mortality
Caregiving Condition Nutrition Condition
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Serious Adverse Events
Caregiving Condition Nutrition Condition
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Caregiving Condition Nutrition Condition
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Loewenstein
Organization: University of Miami
Phone: 305-355-7016
EMail: dloewenstein@miami.edu
Layout table for additonal information
Responsible Party: David Loewenstein, University of Miami
ClinicalTrials.gov Identifier: NCT03049501    
Other Study ID Numbers: 20130460
R01NR014434 ( U.S. NIH Grant/Contract )
First Submitted: February 8, 2017
First Posted: February 10, 2017
Results First Submitted: April 29, 2019
Results First Posted: June 25, 2019
Last Update Posted: June 25, 2019