StrokeNCT03645759
Improving Quality of Life for Veterans With Stroke and Psychological Distress
A study testing I'm Whole in people with Stroke and Depression, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Depression, Anxiety
- What is being tested?
- I'm Whole
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2019to 21 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
About this study
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.
Read the 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.
- Conditions
- Stroke, Depression, Anxiety
- Being tested
- I'm Whole, Education + usual care
- Keywords
- behavioral treatment, telehealth, stroke self-management, psychological distress, social integration
- Medical subject headings
- Stroke, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I'm WholeBehavioural
I'm whole will provide 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration.
Education + usual careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Education + usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Absolute values at 12 weeks post-treatment are being reported
Secondary outcomes (4)
Physical Activity and Disability Survey Change
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.
Measured: The absolute values at 12 weeks post-treatment are being reported
Community Integration Questionnaire Change
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.
Measured: The absolute values at 12 weeks post-treatment are being reported
Patient Health Questionnaire-8 Item Change
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.
Measured: The absolute values at 12 weeks post-treatment are being reported
General Anxiety Disorder-7 Change
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.
Measured: The absolute values at 12 weeks post-treatment are being reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start20 Nov 2019
- Primary completion31 Aug 2021
- Study completion21 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Gina L. Evans, PhD, Principal investigator, Michael E. DeBakey VA Medical Center, Houston, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645759
- Sponsor's protocol ID
- D2898-P
- Other IDs
- I21RX002898-01A1
- Status last verified
- Apr 2024
- First submitted
- 21 Aug 2018
- Last updated
- 18 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Quality of Life for Veterans With Stroke and Psychological Distress
- ClinicalTrials.gov ID
- NCT03645759
- Acronym / sponsor ID
- D2898-P
- Conditions
- Stroke, Depression, Anxiety
- Keywords
- behavioral treatment, telehealth, stroke self-management, psychological distress, social integration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Posted 18 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| I'm Whole | Experimental | Behavioral: I'm WholeThis 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. |
| Education + usual care | Active comparator | Other: Education + usual careThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I'm WholeI'm whole will provide 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration. | Behavioural | I'm Whole |
| Education + usual careWill 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 |
Primary outcome
Stroke Specific Quality of Life Scale Change
Time frame: Absolute values at 12 weeks post-treatment are being reported
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.
4 secondary outcomes
Physical Activity and Disability Survey Change
Time frame: The absolute values at 12 weeks post-treatment are being reported
Community Integration Questionnaire Change
Time frame: The absolute values at 12 weeks post-treatment are being reported
Patient Health Questionnaire-8 Item Change
Time frame: The absolute values at 12 weeks post-treatment are being reported
General Anxiety Disorder-7 Change
Time frame: The absolute values at 12 weeks post-treatment are being reported
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gina L. Evans, PhD principal investigator
Michael E. DeBakey VA Medical Center, Houston, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I'm Whole in people with Stroke and Depression, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke Specific Quality of Life Scale Change (time frame: Absolute values at 12 weeks post-treatment are being reported). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.