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Improving Quality of Life for Veterans With Stroke and Psychological Distress

Primary Purpose

Stroke, Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
I'm Whole
Education + usual care
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring behavioral treatment, telehealth, stroke self-management, psychological distress, social integration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • a documented history of stroke and/or transient ischemic attack within the last 30 days
  • a modified Rankin score of > 3)
  • regular access to a computer or tablet with internet and a camera
  • ability to give appropriate informed consent
  • score > 5 on a measure of depression (Patient Health Questionnaire [PHQ-8]) and/or >17 on a measure of anxiety (Generalized Anxiety Disorder-7 [GAD-7]) assessments
  • ability to ambulate with or without assistance of a cane or walker

Exclusion Criteria:

  • cognitive impairment, as evidenced by a score of >3 on a brief cognitive screener
  • documented diagnosis of psychotic disorder or schizophrenia
  • documented severe depression, anxiety (based on PHQ-8 or GAD-7 score of > 20), or hospitalization for psychiatric illness within the past 30 days

Sites / Locations

  • Michael E. DeBakey VA Medical Center, Houston, TX

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

I'm Whole

Education + usual care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Stroke Specific Quality of Life Scale Change
The scale assesses change in energy, language, vision, mobility, fine motor tasks, mood, personality and thinking, social roles, family roles and work productivity. Subscale scores will be reported for the energy, language, mobility, personality, mood, family roles, thinking, and social roles. The score range for each subscale is 1=need total help to 5=need no help at all.

Secondary Outcome Measures

Stroke Impact Scale Change
The scale assesses change in exercise, leisure time physical activity, indoor and outdoor household activity, wheelchair ambulation, employment-related activity, and rehabilitation therapy-related activity. The total score is reported and the total range will be provided. The score range is 1=All of the time 5=None of the time. Higher values represent a better outcome.
Physical Activity and Disability Survey Change
The survey measures change in exercise, leisure time physical activity, indoor and outdoor household activity, wheelchair ambulation, employment-related activity and rehabilitation therapy-related activity. Subscale scores will be 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.
Subjective Index of Physical and Social Outcome Change
The survey measures change in a patient's subjective assessment of his/her social integration after a stroke in physical and social components. The two subscale scores will be reported. The score range for each subscale is 0=poor integration to 4=highly integrated. Higher values represent a better outcome.
Community Integration Questionnaire Change
The 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). Subscale scores will be reported for each subscale. The score range for each subscale is 1=you yourself alone 3=someone else. Lower values represent a better outcome.
Patient Health Questionnaire-8 item Change
The questionnaire assesses change in severity of depression symptoms over the last two weeks. The total score is reported and the total range will be provided. The score range is 0=Not at all to 3=Nearly every day. Lower values represent a better outcome.
General Anxiety Disorder-7 Change
The questionnaire assesses change severity of anxiety symptoms over the last two weeks. The total score is reported and the total range will be provided. The score range is 0=Not at all to 3=Nearly every day. Lower values represent a better outcome.

Full Information

First Posted
August 21, 2018
Last Updated
March 4, 2022
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT03645759
Brief Title
Improving Quality of Life for Veterans With Stroke and Psychological Distress
Official Title
Improving Quality of Life for Veterans With Stroke and Psychological Distress
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 20, 2019 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
December 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study will create a treatment to improves mobility, physical activity, engagement in activities with family and friends and overall satisfaction with life for Veterans who have depression and anxiety after having a stroke. The treatment will then be tested to ensure it makes the desired improvements in the Veterans.
Detailed Description
The study has three aims. The first aim is to develop a client-centered, behavioral stroke self-management program (I'm Whole) for Veterans with stroke and psychological distress (e.g., symptoms of anxiety and/or depression). This will be done using expert input from a multidisciplinary team of a clinical psychologist, nurse practitioner, exercise physiologist and social role functioning expert will be used to create the I'm Whole patient workbook and clinician manual. The second aim is to pilot the I'm Whole treatment by delivering the intervention to 5 Veterans suffering from stroke and comorbid depression and/or anxiety symptoms. The feasibility (barriers and facilitators to completing I'm Whole and acceptability of the intervention) will be assessed through qualitative interviews posttreatment. Veterans' feedback about ways to improve I'm Whole will be analyzed and used to improve treatment. The third aim is to test the feasibility and preliminary efficacy of I'm Whole on quality of life (primary outcome) physical functioning, physical activity, social role functioning, psychological distress, and satisfaction with I'm Whole (secondary outcomes). To test the feasibility and efficacy, a small randomized controlled trial (RCT) with 30 Veterans (15 I'm Whole and 15 education+usual care) with stroke and psychological distress will be conducted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Depression, Anxiety
Keywords
behavioral treatment, telehealth, stroke self-management, psychological distress, social integration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Behavioral treatment intervention that focuses on enhancing stroke self-management, psychological distress and social functioning that will be provided to two groups (treatment and education plus usual care).
Masking
ParticipantInvestigator
Masking Description
No other parties will be masked
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I'm Whole
Arm Type
Experimental
Arm Description
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.
Arm Title
Education + usual care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
I'm Whole
Intervention Description
I'm whole will provide 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration.
Intervention Type
Other
Intervention Name(s)
Education + usual care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stroke Specific Quality of Life Scale Change
Description
The scale assesses change in energy, language, vision, mobility, fine motor tasks, mood, personality and thinking, social roles, family roles and work productivity. Subscale scores will be reported for the energy, language, mobility, personality, mood, family roles, thinking, and social roles. The score range for each subscale is 1=need total help to 5=need no help at all.
Time Frame
Assessments will be administered at 0, 6 weeks, and 12 weeks posttreatment
Secondary Outcome Measure Information:
Title
Stroke Impact Scale Change
Description
The scale assesses change in exercise, leisure time physical activity, indoor and outdoor household activity, wheelchair ambulation, employment-related activity, and rehabilitation therapy-related activity. The total score is reported and the total range will be provided. The score range is 1=All of the time 5=None of the time. Higher values represent a better outcome.
Time Frame
Assessments will be administered at 0, 6 weeks, and 12 weeks posttreatment
Title
Physical Activity and Disability Survey Change
Description
The survey measures change in exercise, leisure time physical activity, indoor and outdoor household activity, wheelchair ambulation, employment-related activity and rehabilitation therapy-related activity. Subscale scores will be 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.
Time Frame
Assessments will be administered at 0, 6 weeks, and 12 weeks posttreatment
Title
Subjective Index of Physical and Social Outcome Change
Description
The survey measures change in a patient's subjective assessment of his/her social integration after a stroke in physical and social components. The two subscale scores will be reported. The score range for each subscale is 0=poor integration to 4=highly integrated. Higher values represent a better outcome.
Time Frame
Assessments will be administered at 0, 6 weeks, and 12 weeks posttreatment
Title
Community Integration Questionnaire Change
Description
The 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). Subscale scores will be reported for each subscale. The score range for each subscale is 1=you yourself alone 3=someone else. Lower values represent a better outcome.
Time Frame
Assessments will be administered at 0, 6 weeks, and 12 weeks posttreatment
Title
Patient Health Questionnaire-8 item Change
Description
The questionnaire assesses change in severity of depression symptoms over the last two weeks. The total score is reported and the total range will be provided. The score range is 0=Not at all to 3=Nearly every day. Lower values represent a better outcome.
Time Frame
Assessments will be administered at 0, 6 weeks, and 12 weeks posttreatment
Title
General Anxiety Disorder-7 Change
Description
The questionnaire assesses change severity of anxiety symptoms over the last two weeks. The total score is reported and the total range will be provided. The score range is 0=Not at all to 3=Nearly every day. Lower values represent a better outcome.
Time Frame
Assessments will be administered at 0, 6 weeks, and 12 weeks posttreatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: a documented history of stroke and/or transient ischemic attack within the last 30 days a modified Rankin score of > 3) regular access to a computer or tablet with internet and a camera ability to give appropriate informed consent score > 5 on a measure of depression (Patient Health Questionnaire [PHQ-8]) and/or >17 on a measure of anxiety (Generalized Anxiety Disorder-7 [GAD-7]) assessments ability to ambulate with or without assistance of a cane or walker Exclusion Criteria: cognitive impairment, as evidenced by a score of >3 on a brief cognitive screener documented diagnosis of psychotic disorder or schizophrenia documented severe depression, anxiety (based on PHQ-8 or GAD-7 score of > 20), or hospitalization for psychiatric illness within the past 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gina L. Evans, PhD
Organizational Affiliation
Michael E. DeBakey VA Medical Center, Houston, TX
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael E. DeBakey VA Medical Center, Houston, TX
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Improving Quality of Life for Veterans With Stroke and Psychological Distress

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