Improving Quality of Life for Veterans With Stroke and Psychological Distress

Stroke Clinical Trial

Official title:

Improving Quality of Life for Veterans With Stroke and Psychological Distress

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03645759
• Other study ID #: D2898-P
• Secondary ID: I21RX002898-01A1
• Status: Completed
• Phase: N/A
• Start date: November 20, 2019
• Est. completion date: December 21, 2021

Study information

• Verified date: March 2022
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 21, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Stroke

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Michael E. DeBakey VA Medical Center, Houston, TX	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Assessments will be administered at 0, 6 weeks, and 12 weeks posttreatment
Secondary	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.	Assessments will be administered at 0, 6 weeks, and 12 weeks posttreatment
Secondary	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.	Assessments will be administered at 0, 6 weeks, and 12 weeks posttreatment
Secondary	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.	Assessments will be administered at 0, 6 weeks, and 12 weeks posttreatment
Secondary	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.	Assessments will be administered at 0, 6 weeks, and 12 weeks posttreatment
Secondary	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.	Assessments will be administered at 0, 6 weeks, and 12 weeks posttreatment
Secondary	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.	Assessments will be administered at 0, 6 weeks, and 12 weeks posttreatment