Improving Quality of Life for Veterans With Stroke and Psychological Distress

• ClinicalTrials.gov Identifier: NCT03645759
• Recruitment Status: Completed
• First Posted: August 24, 2018
• Last Update Posted: March 8, 2022
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

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.

Condition or disease	Intervention/treatment	Phase
Stroke; Depression; Anxiety	Behavioral: I'm Whole; Other: Education + usual care	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 37 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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: Double (Participant, Investigator)
• Masking Description: No other parties will be masked
• Primary Purpose: Treatment
• Official Title: Improving Quality of Life for Veterans With Stroke and Psychological Distress
• Actual Study Start Date: November 20, 2019
• Actual Primary Completion Date: August 31, 2021
• Actual Study Completion Date: December 21, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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, 6, and 12 weeks.	Behavioral: 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.
Active Comparator: 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.	Other: 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.

Outcome Measures

Primary Outcome Measures :

1. Stroke Specific Quality of Life Scale Change [ Time Frame: Assessments will be administered at 0, 6 weeks, and 12 weeks posttreatment ]
   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 :

1. Stroke Impact Scale Change [ Time Frame: Assessments will be administered at 0, 6 weeks, and 12 weeks posttreatment ]
   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.
2. Physical Activity and Disability Survey Change [ Time Frame: Assessments will be administered at 0, 6 weeks, and 12 weeks posttreatment ]
   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.
3. Subjective Index of Physical and Social Outcome Change [ Time Frame: Assessments will be administered at 0, 6 weeks, and 12 weeks posttreatment ]
   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.
4. Community Integration Questionnaire Change [ Time Frame: Assessments will be administered at 0, 6 weeks, and 12 weeks posttreatment ]
   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.
5. Patient Health Questionnaire-8 item Change [ Time Frame: Assessments will be administered at 0, 6 weeks, and 12 weeks posttreatment ]
   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.
6. General Anxiety Disorder-7 Change [ Time Frame: Assessments will be administered at 0, 6 weeks, and 12 weeks posttreatment ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Texas

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, United States, 77030

Sponsors and Collaborators

VA Office of Research and Development

Investigators

• Principal Investigator: Gina L. Evans, PhD; Michael E. DeBakey VA Medical Center, Houston, TX

More Information

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT03645759
• Other Study ID Numbers: D2898-P; I21RX002898-01A1 ( U.S. NIH Grant/Contract )
• First Posted: August 24, 2018
• Last Update Posted: March 8, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by VA Office of Research and Development:

behavioral treatment; telehealth; stroke self-management; psychological distress; social integration

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases