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Transition Programs for Stroke (COMPASS Trial)

N/A

Waitlist Available

Led By Susan Stark, PhD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

aged ≥50 years

acute ischemic or hemorrhagic stroke diagnosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post-stroke

Awards & highlights

COMPASS Trial Summary

This trial is testing two different programs to help people recovering from a stroke transition back home. One program focuses on education and the other on environmental modifications.

Who is the study for?

This trial is for individuals aged 50 or older who have had an ischemic or hemorrhagic stroke and are transitioning home from inpatient rehab. They must have been independent in daily activities before the stroke and not suffer from severe cognitive impairments, dementia, live in group housing, terminal diseases with less than 6 months to live, or significant language loss.Check my eligibility

What is being tested?

The study is testing a novel program aimed at reducing disability after patients return home post-stroke. Participants will be randomly assigned to receive either standard stroke education or a specialized environmental modifications program designed to aid their recovery.See study design

What are the potential side effects?

Since this trial involves educational and environmental interventions rather than medications, traditional side effects are not expected. However, there may be varying levels of stress or emotional impact associated with adapting to new routines and environments.

COMPASS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 50 years old or older.

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I have been diagnosed with a stroke.

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I was independent in daily activities before my stroke.

COMPASS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post-stroke

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months post-stroke

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post-stroke for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Reintegration to Normal Living Index (RNLI)

Secondary outcome measures

In-Home Occupational Performance Evaluation (I-HOPE)

Stroke Impact Scale (SIS)

COMPASS Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: COMPASSExperimental Treatment1 Intervention

COMPASS is a complex intervention that combines 2 evidence-based treatment strategies at a new point of care (transition from inpatient rehabilitation). The objective of home visits by an occupational therapy (OT) practitioner is to remediate barriers in the home and community that influence daily activities and community participation. The treatment will include a set of 1 predischarge and four 75-minute postdischarge visits. The intervention is followed by 2 booster sessions.

Group II: Education programPlacebo Group1 Intervention

An OT practitioner will deliver the program in accordance with "Evidence-Based Educational Guidelines for Stroke Survivors after Discharge Home." Topic order is determined by participants. Four 75-minute sessions will be provided. Topics may include stroke symptoms, risk factors and preventing stroke recurrence, nutrition, managing emotions, sleep, pain. Written materials from the National Stroke Association and the American Stroke Association are provided.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

COMPASS

2015

N/A

~2850

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,964 Previous Clinical Trials

2,674,545 Total Patients Enrolled

6 Trials studying Ischemic Stroke

458 Patients Enrolled for Ischemic Stroke

Washington University School of MedicineLead Sponsor

1,933 Previous Clinical Trials

2,299,540 Total Patients Enrolled

4 Trials studying Ischemic Stroke

674 Patients Enrolled for Ischemic Stroke

Susan Stark, PhDPrincipal InvestigatorWashington University School of Medicine

5 Previous Clinical Trials

2,001 Total Patients Enrolled

Media Library

COMPASS Clinical Trial Eligibility Overview. Trial Name: NCT03485820 — N/A

Ischemic Stroke Research Study Groups: COMPASS, Education program

Ischemic Stroke Clinical Trial 2023: COMPASS Highlights & Side Effects. Trial Name: NCT03485820 — N/A

COMPASS 2023 Treatment Timeline for Medical Study. Trial Name: NCT03485820 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any enrollment opportunities currently available for this research study?

"Details posted on clinicaltrials.gov indicate that this medical trial is not presently accepting new participants, even though it was last modified in April of 2022. Nevertheless, there are over one thousand other studies actively recruiting patients for experimentation at the moment."

Answered by AI

Recent research and studies

JAMA Network OpenJournal

Effect of a Novel Transition Program on Disability After Stroke

Somerville, Emily, Brittany Minor, Marian Keglovits, Yan Yan, and Susan Stark. 2019. “Effect of a Novel Transition Program on Disability After Stroke”. JAMA Network Open. American Medical Association (AMA). doi:10.1001/jamanetworkopen.2019.12356.

clinicaltrials.govStudy

A Novel Transition Program to Reduce Disability After Stroke

2018. "A Novel Transition Program to Reduce Disability After Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03485820.