Improving Quality of Life for Veterans With Stroke and Psychological Distress

NCT03645759 | Completed Results

• 2 other identifiers: D2898-PI21RX002898-01A1
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Depression; Anxiety

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Stroke Specific Quality of Life Scale Change

  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.

  Absolute values at 12 weeks post-treatment are being reported

Secondary Outcomes (4)

• Physical Activity and Disability Survey Change

  The absolute values at 12 weeks post-treatment are being reported

• Community Integration Questionnaire Change

  The absolute values at 12 weeks post-treatment are being reported

• Patient Health Questionnaire-8 Item Change

  The absolute values at 12 weeks post-treatment are being reported

• General Anxiety Disorder-7 Change

  The absolute values at 12 weeks post-treatment are being reported

Study Arms (2)

I'm Whole

EXPERIMENTAL

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

Education + usual care

ACTIVE COMPARATOR

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

Interventions

I'm Whole BEHAVIORAL

I'm whole will provide 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration.

I'm Whole

Education + usual care OTHER

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.

Education + usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Stroke; Depression; Anxiety Disorders

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Limitations and Caveats

The small sample size is a limitation.

Results Point of Contact

• Title: Dr. Gina Evans
• Organization: Michael E. Debakey VA Medical Center

gina.evans@va.gov

832-269-3048

Study Officials

• Gina L. Evans, PhD

  Michael E. DeBakey VA Medical Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: No other parties will be masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 24, 2018
• Study Start: November 20, 2019
• Primary Completion: August 31, 2021
• Study Completion: December 21, 2021
• Last Updated: July 18, 2024
• Results First Posted: July 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)