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NCT03645759

Improving Quality of Life for Veterans With Stroke and Psychological Distress

Completed NA Results posted Last updated 18 July 2024
What this trial tests

NA trial testing I'm Whole in Stroke in 38 participants. Completed in 21 December 2021.

Timeline
20 November 2019
Primary endpoint
31 August 2021
21 December 2021

Quick facts

Lead sponsorVA Office of Research and Development
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment38
Start date20 November 2019
Primary completion31 August 2021
Estimated completion21 December 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Stroke or Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Stroke Specific Quality of Life Scale Change Primary · 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.

GroupValue95% CI
I'm Whole41.24± 6.30
Education + Usual Care41.67± 5.80
Physical Activity and Disability Survey Change Secondary · The absolute values at 12 weeks post-treatment are being reported

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.

GroupValue95% CI
I'm Whole602± 48
Education + Usual Care60± 22
Community Integration Questionnaire Change Secondary · The absolute values at 12 weeks post-treatment are being reported

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.

GroupValue95% CI
I'm Whole16.8± 4.21
Education + Usual Care13.8± 4.23
Patient Health Questionnaire-8 Item Change Secondary · The absolute values at 12 weeks post-treatment are being reported

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.

GroupValue95% CI
I'm Whole4.00± 1.10
Education + Usual Care8.21± 0.80
General Anxiety Disorder-7 Change Secondary · The absolute values at 12 weeks post-treatment are being reported

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.

GroupValue95% CI
I'm Whole2.80± 0.82
Education + Usual Care3.91± 1.03

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Pharmacological, non-invasive brain stimulation and psychological interventions, and their combination, for treating depression after stroke.
    Allida SM, Hsieh CF, Cox KL, Patel K, et al · · 2023 · cited 11× · PMID 37417452 · DOI 10.1002/14651858.cd003437.pub5

Verify or expand the search:

Other recruiting trials for Stroke

Currently open trials in the same condition.

Other VA Office of Research and Development trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03645759.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing