Trial Outcomes & Findings for Improving Quality of Life for Veterans With Stroke and Psychological Distress (NCT NCT03645759)
NCT ID: NCT03645759
Last Updated: 2024-07-18
Results Overview
The Stroke Specific Quality of Life Scale assesses change in energy, language, vision, mobility, fine motor tasks, mood, personality and thinking, social roles, family roles and work productivity. Scores are reported for the energy, language, mobility, personality, mood, family roles, thinking, and social roles. The score range for each item 1= strongly disagree to 5=strongly agree with a higher score indicating greater disability and worst outcomes. A total score range is 14-70.
COMPLETED
NA
38 participants
Absolute values at 12 weeks post-treatment are being reported
2024-07-18
Participant Flow
Participant milestones
| Measure |
I'm Whole
This arm will receive 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration. Treatments will occur weekly. They will also receive 3 assessments at 0 and 12 weeks.
I'm Whole: I'm whole will provide 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration.
|
Education + Usual Care
This arm will only receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.
Education + usual care: Will receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
16
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
I'm Whole
This arm will receive 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration. Treatments will occur weekly. They will also receive 3 assessments at 0 and 12 weeks.
I'm Whole: I'm whole will provide 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration.
|
Education + Usual Care
This arm will only receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.
Education + usual care: Will receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
Baseline Characteristics
Improving Quality of Life for Veterans With Stroke and Psychological Distress
Baseline characteristics by cohort
| Measure |
I'm Whole
n=19 Participants
This arm will receive 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration. Treatments will occur weekly. They will also receive 3 assessments at 0, 6, and 12 weeks.
I'm Whole: I'm whole will provide 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration.
|
Education + Usual Care
n=19 Participants
This arm will only receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.
Education + usual care: Will receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Age, Continuous
|
65.44 years
STANDARD_DEVIATION 3.77 • n=99 Participants
|
63.44 years
STANDARD_DEVIATION 4.27 • n=107 Participants
|
64.44 years
STANDARD_DEVIATION 2.87 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
International physical activity questionnaire
|
203 MET Minutes per day
STANDARD_DEVIATION 284 • n=99 Participants
|
143 MET Minutes per day
STANDARD_DEVIATION 233.9 • n=107 Participants
|
173 MET Minutes per day
STANDARD_DEVIATION 258.8 • n=206 Participants
|
|
Sedentary Behaviors Questionnaire
|
5.73 hours spent in sedentary behaviors
STANDARD_DEVIATION 9.49 • n=99 Participants
|
4.51 hours spent in sedentary behaviors
STANDARD_DEVIATION 1.40 • n=107 Participants
|
5.12 hours spent in sedentary behaviors
STANDARD_DEVIATION 5.45 • n=206 Participants
|
|
Community Integration Questionnaire
|
18.60 units on a scale
STANDARD_DEVIATION 4.60 • n=99 Participants
|
29.70 units on a scale
STANDARD_DEVIATION 4.41 • n=107 Participants
|
24.15 units on a scale
STANDARD_DEVIATION 4.51 • n=206 Participants
|
|
Patient-Reported Outcomes Measurement Information System
|
64.04 units on a scale
STANDARD_DEVIATION 5.32 • n=99 Participants
|
61.01 units on a scale
STANDARD_DEVIATION 9.10 • n=107 Participants
|
62.53 units on a scale
STANDARD_DEVIATION 7.21 • n=206 Participants
|
|
Generalized Anxiety Disorder-7 items
|
4.80 units on a scale
STANDARD_DEVIATION 0.70 • n=99 Participants
|
4.52 units on a scale
STANDARD_DEVIATION 1.01 • n=107 Participants
|
4.65 units on a scale
STANDARD_DEVIATION 0.85 • n=206 Participants
|
|
Patient Health Questionnaire
|
11.01 units on a scale
STANDARD_DEVIATION 0.91 • n=99 Participants
|
10.10 units on a scale
STANDARD_DEVIATION 0.70 • n=107 Participants
|
10.55 units on a scale
STANDARD_DEVIATION 0.81 • n=206 Participants
|
|
36-Item Short Form Survey
|
40.23 units on a scale
STANDARD_DEVIATION 9.15 • n=99 Participants
|
51.39 units on a scale
STANDARD_DEVIATION 10.96 • n=107 Participants
|
45.81 units on a scale
STANDARD_DEVIATION 10.06 • n=206 Participants
|
PRIMARY outcome
Timeframe: Absolute values at 12 weeks post-treatment are being reportedPopulation: Estimates of changes in patient-reported outcomes were calculated using intent to-treat approach. The paired change in outcome scores from baseline to the end of the study and differences in paired change in scores in treatment and EUC arms were compared with zero using Wilcoxon's signed-rank test.
The Stroke Specific Quality of Life Scale assesses change in energy, language, vision, mobility, fine motor tasks, mood, personality and thinking, social roles, family roles and work productivity. Scores are reported for the energy, language, mobility, personality, mood, family roles, thinking, and social roles. The score range for each item 1= strongly disagree to 5=strongly agree with a higher score indicating greater disability and worst outcomes. A total score range is 14-70.
Outcome measures
| Measure |
I'm Whole
n=16 Participants
This arm will receive 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration. Treatments will occur weekly. They will also receive 3 assessments at 0, 6, and 12 weeks.
I'm Whole: I'm whole will provide 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration.
|
Education + Usual Care
n=17 Participants
This arm will only receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.
Education + usual care: Will receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.
|
|---|---|---|
|
Stroke Specific Quality of Life Scale Change
|
41.24 units on a scale
Standard Deviation 6.30
|
41.67 units on a scale
Standard Deviation 5.80
|
SECONDARY outcome
Timeframe: The absolute values at 12 weeks post-treatment are being reportedPopulation: Estimates of changes in patient-reported outcomes were calculated using intent to-treat approach. The paired change in outcome scores from baseline to the end of the study and differences in paired change in scores in treatment and EUC arms were compared with zero using Wilcoxon's signed-rank test.
The Physical Activity and Disability Survey measures change in exercise, leisure time physical activity, indoor and outdoor household activity, wheelchair ambulation, employment-related activity and rehabilitation therapy-related activity. Scores were reported for each 6 areas of exercise/activity. The subscale score is based on the self-reported amount of time an individual states they spend performing each exercise. Higher values represent a better outcome and more time spent engaging in the activity. The range of scores are 0-1440 minutes per day.
Outcome measures
| Measure |
I'm Whole
n=16 Participants
This arm will receive 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration. Treatments will occur weekly. They will also receive 3 assessments at 0, 6, and 12 weeks.
I'm Whole: I'm whole will provide 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration.
|
Education + Usual Care
n=17 Participants
This arm will only receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.
Education + usual care: Will receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.
|
|---|---|---|
|
Physical Activity and Disability Survey Change
|
602 units on a scale
Standard Deviation 48
|
60 units on a scale
Standard Deviation 22
|
SECONDARY outcome
Timeframe: The absolute values at 12 weeks post-treatment are being reportedPopulation: Estimates of changes in patient-reported outcomes were calculated using intent to-treat approach. The paired change in outcome scores from baseline to the end of the study and differences in paired change in scores in treatment and EUC arms were compared with zero using Wilcoxon's signed-rank test.
The Community Integration Questionnaire measures change in home integration (i.e., market, meal preparation, household activities, finance), social integration (i.e., shopping, avocation, going out), and productive activity (i.e., work, school, volunteer activity). The score range is 1=you yourself alone 3=someone else. Total score range is 13-39. Lower values represent a better outcome and greater integration into the community.
Outcome measures
| Measure |
I'm Whole
n=16 Participants
This arm will receive 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration. Treatments will occur weekly. They will also receive 3 assessments at 0, 6, and 12 weeks.
I'm Whole: I'm whole will provide 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration.
|
Education + Usual Care
n=17 Participants
This arm will only receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.
Education + usual care: Will receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.
|
|---|---|---|
|
Community Integration Questionnaire Change
|
16.8 units on a scale
Standard Deviation 4.21
|
13.8 units on a scale
Standard Deviation 4.23
|
SECONDARY outcome
Timeframe: The absolute values at 12 weeks post-treatment are being reportedPopulation: Estimates of changes in patient-reported outcomes were calculated using intent to-treat approach. The paired change in outcome scores from baseline to the end of the study and differences in paired change in scores in treatment and EUC arms were compared with zero using Wilcoxon's signed-rank test.
The Patient Health Questionnaire-8 assesses change in severity of depression symptoms over the last two weeks. The score range is 0=Not at all to 3=Nearly every day. Total score range is 0-24. Lower values represent a better outcome and less symptoms of depression.
Outcome measures
| Measure |
I'm Whole
n=16 Participants
This arm will receive 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration. Treatments will occur weekly. They will also receive 3 assessments at 0, 6, and 12 weeks.
I'm Whole: I'm whole will provide 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration.
|
Education + Usual Care
n=17 Participants
This arm will only receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.
Education + usual care: Will receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.
|
|---|---|---|
|
Patient Health Questionnaire-8 Item Change
|
4.00 units on a scale
Standard Deviation 1.10
|
8.21 units on a scale
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: The absolute values at 12 weeks post-treatment are being reportedPopulation: Estimates of changes in patient-reported outcomes were calculated using intent to-treat approach. The paired change in outcome scores from baseline to the end of the study and differences in paired change in scores in treatment and EUC arms were compared with zero using Wilcoxon's signed-rank test.
The General Anxiety Disorder-7 assesses change in severity of anxiety symptoms over the last two weeks. The total score is reported. The score range is 0=Not at all to 3=Nearly every day. Total score range is 0-21. Lower values represent a better outcome and less symptoms of anxiety.
Outcome measures
| Measure |
I'm Whole
n=16 Participants
This arm will receive 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration. Treatments will occur weekly. They will also receive 3 assessments at 0, 6, and 12 weeks.
I'm Whole: I'm whole will provide 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration.
|
Education + Usual Care
n=17 Participants
This arm will only receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.
Education + usual care: Will receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.
|
|---|---|---|
|
General Anxiety Disorder-7 Change
|
2.80 units on a scale
Standard Deviation 0.82
|
3.91 units on a scale
Standard Deviation 1.03
|
Adverse Events
I'm Whole
Education + Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place