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Video-Enhanced Care Management for Medically Complex Veterans

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: NCT02962687
Recruitment Status : Completed
First Posted : November 11, 2016
Results First Posted : September 13, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Conditions Multimorbidity
Cognitive Impairments
Interventions Behavioral: Care management via videoconference
Behavioral: Care management via telephone calls
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Videoconference Care Management Telephone Care Management
Hide Arm/Group Description

12-week nurse care management for medically complex Veterans with CI delivered via videoconferencing

Care management via videoconference: 12-week nurse care management for medically complex Veterans with cognitive impairment delivered via videoconference

12-week nurse care management for medically complex Veterans with CI delivered via telephone calls

Care management via telephone calls: 12-week nurse care management for medically complex Veterans with cognitive impairment delivered via telephone calls

Period Title: Overall Study
Started 40 [1] 40 [1]
Completed 30 [2] 32 [3]
Not Completed 10 8
[1]
This number represents 20 dyads (1 Veteran and 1 caregiver in each dyad)
[2]
This number represents 15 dyads (1 Veteran and 1 caregiver in each dyad)
[3]
This number represents 16 dyads (1 Veteran and 1 caregiver in each dyad)
Arm/Group Title Videoconference Care Management Telephone Care Management Total
Hide Arm/Group Description

12-week nurse care management for medically complex Veterans with CI delivered via videoconferencing

Care management via videoconference: 12-week nurse care management for medically complex Veterans with CI delivered via videoconference

12-week nurse care management for medically complex Veterans with CI delivered via telephone calls

Care management via telephone calls: 12-week nurse care management for medically complex Veterans with CI delivered via telephone calls

Total of all reporting groups
Overall Number of Baseline Participants 40 40 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Veterans Number Analyzed 20 participants 20 participants 40 participants
70.2  (3.8) 74.6  (7.1) 72.4  (6.1)
Caregivers Number Analyzed 20 participants 20 participants 40 participants
60.6  (12.0) 68.9  (7.7) 64.7  (10.8)
[1]
Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs). Number analyzed in video intervention group=20 dyads (20 Veterans + 20 caregivers = 40 participants). Phone intervention group=20 dyads(20 Veterans + 20 caregivers = 40 participants).
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Veterans Number Analyzed 20 participants 20 participants 40 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
20
 100.0%
20
 100.0%
40
 100.0%
Caregivers Number Analyzed 20 participants 20 participants 40 participants
Female
19
  95.0%
19
  95.0%
38
  95.0%
Male
1
   5.0%
1
   5.0%
2
   5.0%
[1]
Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs). Number analyzed in video intervention group=20 dyads (20 Veterans + 20 caregivers = 40 participants). Phone intervention group=20 dyads(20 Veterans + 20 caregivers = 40 participants).
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Veterans Number Analyzed 20 participants 20 participants 40 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
20
 100.0%
20
 100.0%
40
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Caregivers Number Analyzed 20 participants 20 participants 40 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
20
 100.0%
20
 100.0%
40
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs). Number analyzed in video intervention group=20 dyads (20 Veterans + 20 caregivers = 40 participants). Phone intervention group=20 dyads(20 Veterans + 20 caregivers = 40 participants).
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Veterans Number Analyzed 20 participants 20 participants 40 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
8
  40.0%
7
  35.0%
15
  37.5%
White
12
  60.0%
13
  65.0%
25
  62.5%
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%
Caregivers Number Analyzed 20 participants 20 participants 40 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
8
  40.0%
3
  15.0%
11
  27.5%
White
12
  60.0%
17
  85.0%
29
  72.5%
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: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs). Number analyzed in video intervention group=20 dyads (20 Veterans + 20 caregivers = 40 participants). Phone intervention group=20 dyads(20 Veterans + 20 caregivers = 40 participants).
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 40 participants 40 participants 80 participants
40
 100.0%
40
 100.0%
80
 100.0%
Internet Use in Last Year   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Veterans Number Analyzed 20 participants 20 participants 40 participants
15
  75.0%
13
  65.0%
28
  70.0%
Caregivers Number Analyzed 20 participants 20 participants 40 participants
19
  95.0%
13
  65.0%
32
  80.0%
[1]
Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs). Number analyzed in video intervention group=20 dyads (20 Veterans + 20 caregivers = 40 participants). Phone intervention group=20 dyads(20 Veterans + 20 caregivers = 40 participants).
Comfortable with Using the Internet   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Veterans Number Analyzed 20 participants 20 participants 40 participants
7
  35.0%
8
  40.0%
15
  37.5%
Caregivers Number Analyzed 20 participants 20 participants 40 participants
16
  80.0%
11
  55.0%
27
  67.5%
[1]
Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs). Number analyzed in video intervention group=20 dyads (20 Veterans + 20 caregivers = 40 participants). Phone intervention group=20 dyads(20 Veterans + 20 caregivers = 40 participants).
Has Accessed Internet with Tablet Computer   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Veterans Number Analyzed 20 participants 20 participants 40 participants
4
  20.0%
2
  10.0%
6
  15.0%
Caregivers Number Analyzed 20 participants 20 participants 40 participants
12
  60.0%
4
  20.0%
16
  40.0%
[1]
Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs). Number analyzed in video intervention group=20 dyads (20 Veterans + 20 caregivers = 40 participants). Phone intervention group=20 dyads(20 Veterans + 20 caregivers = 40 participants).
Previously Used Videochat   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Veterans Number Analyzed 20 participants 20 participants 40 participants
5
  25.0%
6
  30.0%
11
  27.5%
Caregivers Number Analyzed 20 participants 20 participants 40 participants
13
  65.0%
10
  50.0%
23
  57.5%
[1]
Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs). Number analyzed in video intervention group=20 dyads (20 Veterans + 20 caregivers = 40 participants). Phone intervention group=20 dyads(20 Veterans + 20 caregivers = 40 participants).
Likely to see healthcare provider using videochat   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Veterans Number Analyzed 20 participants 20 participants 40 participants
11
  55.0%
8
  40.0%
19
  47.5%
Caregivers Number Analyzed 20 participants 20 participants 40 participants
12
  60.0%
14
  70.0%
26
  65.0%
[1]
Measure Analysis Population Description: The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs). Number analyzed in video intervention group=20 dyads (20 Veterans + 20 caregivers = 40 participants). Phone intervention group=20 dyads(20 Veterans + 20 caregivers = 40 participants).
1.Primary Outcome
Title Number of Participants Reporting That They Would Be Likely to See a Healthcare Provider Using Videochat
Hide Description Acceptability will be assessed using the measure of likelihood of seeing a healthcare provider using videochat.
Time Frame 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
These numbers represent the Veterans in the sample (Care Partners not analyzed)
Arm/Group Title Videoconference Care Management Telephone Care Management
Hide Arm/Group Description:

12-week nurse care management for medically complex Veterans with CI delivered via videoconferencing

Care management via videoconference: 12-week nurse care management for medically complex Veterans with CI delivered via videoconference

12-week nurse care management for medically complex Veterans with CI delivered via telephone calls

Care management via telephone calls: 12-week nurse care management for medically complex Veterans with CI delivered via telephone calls

Overall Number of Participants Analyzed 15 16
Measure Type: Count of Participants
Unit of Measure: Participants
6
  40.0%
5
  31.3%
2.Primary Outcome
Title Number of Scheduled Intervention Phone or Video Calls Completed by Participants
Hide Description Feasibility will be assessed by examining rates of adherence to intervention phone/video calls.
Time Frame 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
These number represent the Veterans in the sample (Care Partners not analyzed)
Arm/Group Title Videoconference Care Management Telephone Care Management
Hide Arm/Group Description:

12-week nurse care management for medically complex Veterans with CI delivered via videoconferencing

Care management via videoconference: 12-week nurse care management for medically complex Veterans with CI delivered via videoconference

12-week nurse care management for medically complex Veterans with CI delivered via telephone calls

Care management via telephone calls: 12-week nurse care management for medically complex Veterans with CI delivered via telephone calls

Overall Number of Participants Analyzed 15 16
Overall Number of Units Analyzed
Type of Units Analyzed: Calls
60 60
Count of Units
Unit of Measure: calls
46
  76.7%
53
  88.3%
3.Primary Outcome
Title Usability of Video-Enhanced Care Management for Medically Complex Veterans With CI
Hide Description Usability of the video-enhanced care management program will be examined using the System Usability Scale (SUS; range 0 - 100; higher scores are better).
Time Frame 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The System Usability Scale was administered only to the videoconference care management Veteran participants.
Arm/Group Title Videoconference Care Management Telephone Care Management
Hide Arm/Group Description:

12-week nurse care management for medically complex Veterans with CI delivered via videoconferencing

Care management via videoconference: 12-week nurse care management for medically complex Veterans with CI delivered via videoconference

12-week nurse care management for medically complex Veterans with CI delivered via telephone calls

Care management via telephone calls: 12-week nurse care management for medically complex Veterans with CI delivered via telephone calls

Overall Number of Participants Analyzed 15 0
Mean (Standard Deviation)
Unit of Measure: score on a scale
59.3  (18.6)
4.Other Pre-specified Outcome
Title Number of Participants With Hospitalizations or Emergency Department Visits
Hide Description Descriptive analysis of emergency department visits and hospitalizations in the two study arms
Time Frame 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Utilization data was collected for Veteran participants only.
Arm/Group Title Videoconference Care Management Telephone Care Management
Hide Arm/Group Description:

12-week nurse care management for medically complex Veterans with CI delivered via videoconferencing

Care management via videoconference: 12-week nurse care management for medically complex Veterans with CI delivered via videoconference

12-week nurse care management for medically complex Veterans with CI delivered via telephone calls

Care management via telephone calls: 12-week nurse care management for medically complex Veterans with CI delivered via telephone calls

Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: participants
Hospitalizations 2 1
ED Visits 4 1
5.Other Pre-specified Outcome
Title Physical Activity
Hide Description Descriptive analysis of physical activity as measured by the Physical Activity Scale for the Elderly (PASE; range 0 - 360; higher scores are better)
Time Frame 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The PASE was administered to the Veteran participants only.
Arm/Group Title Videoconference Care Management Telephone Care Management
Hide Arm/Group Description:

12-week nurse care management for medically complex Veterans with CI delivered via videoconferencing

Care management via videoconference: 12-week nurse care management for medically complex Veterans with CI delivered via videoconference

12-week nurse care management for medically complex Veterans with CI delivered via telephone calls

Care management via telephone calls: 12-week nurse care management for medically complex Veterans with CI delivered via telephone calls

Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: weighted sum
75.1  (65.1) 108.9  (73.8)
6.Other Pre-specified Outcome
Title Quality of Life Outcome
Hide Description Descriptive analysis of health-related quality of life as measured by 3 subscales of the Patient Reported Outcomes Measurement Information System (PROMIS-29; range 4 - 20 for each; lower scores are better)
Time Frame 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The PROMIS subscales were administered to the Veteran participants only.
Arm/Group Title Videoconference Care Management Telephone Care Management
Hide Arm/Group Description:

12-week nurse care management for medically complex Veterans with CI delivered via videoconferencing

Care management via videoconference: 12-week nurse care management for medically complex Veterans with CI delivered via videoconference

12-week nurse care management for medically complex Veterans with CI delivered via telephone calls

Care management via telephone calls: 12-week nurse care management for medically complex Veterans with CI delivered via telephone calls

Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: score on a scale
PROMIS-29 (Pain Interference) 11.5  (5.7) 10.9  (4.8)
PROMIS-29 (Physical Function) 12.3  (4.2) 11.4  (5.5)
PROMIS-29 (Social Roles) 10.8  (3.8) 11.5  (4.9)
7.Other Pre-specified Outcome
Title Depression
Hide Description Descriptive analysis of depression as measured by Patient Health Questionnaire-Depression (PHQ-9; range 0 - 27; lower scores are better)
Time Frame 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The PHQ-9 was administered to the Veteran participants only.
Arm/Group Title Videoconference Care Management Telephone Care Management
Hide Arm/Group Description:

12-week nurse care management for medically complex Veterans with CI delivered via videoconferencing

Care management via videoconference: 12-week nurse care management for medically complex Veterans with CI delivered via videoconference

12-week nurse care management for medically complex Veterans with CI delivered via telephone calls

Care management via telephone calls: 12-week nurse care management for medically complex Veterans with CI delivered via telephone calls

Overall Number of Participants Analyzed 15 16
Mean (Standard Deviation)
Unit of Measure: score on a scale
6.4  (5.8) 4.6  (3.7)
8.Other Pre-specified Outcome
Title Social Support
Hide Description Descriptive analysis of social support as measured by modified Medical Outcomes Study Social Support Survey (mMOS-SS; range 0 - 100; higher scores are better)
Time Frame 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The mMOS-SS was administered to the Veteran participants only.
Arm/Group Title Videoconference Care Management Telephone Care Management
Hide Arm/Group Description:

12-week nurse care management for medically complex Veterans with CI delivered via videoconferencing

Care management via videoconference: 12-week nurse care management for medically complex Veterans with CI delivered via videoconference

12-week nurse care management for medically complex Veterans with CI delivered via telephone calls

Care management via telephone calls: 12-week nurse care management for medically complex Veterans with CI delivered via telephone calls

Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: score on a scale
70.2  (26.0) 72.7  (26.0)
9.Other Pre-specified Outcome
Title Anxiety
Hide Description Descriptive analysis of anxiety as measured by the Generalized Anxiety Disorder Scale (GAD-7; range 0 - 21; lower scores are better)
Time Frame 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The GAD-7 was administered to the Veteran participants only.
Arm/Group Title Videoconference Care Management Telephone Care Management
Hide Arm/Group Description:

12-week nurse care management for medically complex Veterans with CI delivered via videoconferencing

Care management via videoconference: 12-week nurse care management for medically complex Veterans with CI delivered via videoconference

12-week nurse care management for medically complex Veterans with CI delivered via telephone calls

Care management via telephone calls: 12-week nurse care management for medically complex Veterans with CI delivered via telephone calls

Overall Number of Participants Analyzed 15 16
Mean (Standard Deviation)
Unit of Measure: score on a scale
4.2  (3.5) 4.3  (3.8)
Time Frame 14 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Videoconference Care Management - Veterans Telephone Care Management - Veterans Videoconference Care Management - Care Partners Telephone Care Management - Care Partners
Hide Arm/Group Description

12-week nurse care management for medically complex Veterans with CI delivered via videoconferencing

Care management via videoconference: 12-week nurse care management for medically complex Veterans with CI delivered via videoconference

12-week nurse care management for medically complex Veterans with CI delivered via telephone calls

Care management via telephone calls: 12-week nurse care management for medically complex Veterans with CI delivered via telephone calls

12-week nurse care management for medically complex Veterans with CI and their care partners delivered via videoconferencing

Care management via videoconference: 12-week nurse care management for medically complex Veterans with CI and their care partners delivered via videoconference

12-week nurse care management for medically complex Veterans with CI and their care partners delivered via telephone calls

Care management via telephone calls: 12-week nurse care management for medically complex Veterans with CI and their care partners delivered via telephone calls

All-Cause Mortality
Videoconference Care Management - Veterans Telephone Care Management - Veterans Videoconference Care Management - Care Partners Telephone Care Management - Care Partners
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/20 (5.00%)      0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Videoconference Care Management - Veterans Telephone Care Management - Veterans Videoconference Care Management - Care Partners Telephone Care Management - Care Partners
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/20 (5.00%)      1/20 (5.00%)      0/20 (0.00%)      0/20 (0.00%)    
Cardiac disorders         
Hospitalization * [1]  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0
Vascular disorders         
Hospitalization * [1]  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Adverse events are reported as monitored/assessed
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Videoconference Care Management - Veterans Telephone Care Management - Veterans Videoconference Care Management - Care Partners Telephone Care Management - Care Partners
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/20 (20.00%)      3/20 (15.00%)      0/20 (0.00%)      0/20 (0.00%)    
Cardiac disorders         
ED Visit * [1]  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0
General disorders         
ED Visit * [1]  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Infections and infestations         
ED Visit * [1]  2/20 (10.00%)  2 1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Psychiatric disorders         
ED Visit * [1]  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
ED Visit * [1]  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Adverse events are reported as monitored/assessed
Perceived value associated with each delivery method was removed as an outcome on 2/13/19 because data are being analyzed as qualitative data; there are no quant data to report.
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: Susan N Hastings
Organization: Durham VA HSR&D
Phone: 919-286-6986
EMail: susan.hastings@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02962687     History of Changes
Other Study ID Numbers: PPO 15-425
First Submitted: October 25, 2016
First Posted: November 11, 2016
Results First Submitted: February 15, 2019
Results First Posted: September 13, 2019
Last Update Posted: September 13, 2019