StrokeNCT04019275

ENGAGE Pilot Study: Promoting Participation and Health After Stroke

A study testing ENGAGE in people with Stroke, run by University of Pittsburgh at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Stroke
What is being tested?: ENGAGE
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 3 sitesUnited States
Study dates: 1 Sep 2019to 30 Dec 2022
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

ages 18 and older
chronic stroke (minimum 3 months)
community-dwelling
mild to moderate stroke-related disability (NIHSS<=16)
restrictions in community participation (ACS <80% of pre-stroke activities)
low income (uninsured or underinsured)
able to provide written informed consent

Who cannot join

currently receiving rehabilitation serves
dementia diagnosis
severe aphasia (BDAE=0 or 1)
current major depressive disorder (unless treated and in partial remission)
current bipolar or psychotic disorder
substance abuse within 3 months

Trial locations and contacts

3 sites in 1 country.

United States3 sites

University of Illinois at Chicago
Chicago, Illinois, 60612
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
Washington University
St Louis, Missouri, 63108

Other trials in United States

About this study

This is a multi-site single-arm community-based pilot study examining the feasibility, acceptability, safety, and estimated effects of the ENGAGE intervention, a community-based intervention to promote community participation after stroke. The study will also characterize variances in changes in community participation outcomes. These findings will provide the pilot data needed to inform a multi-site randomized controlled clinical trial.

Read the detailed description

Significant advancements in acute medical management have shifted stroke from an acute condition with a high prevalence of mortality to a chronic condition with high prevalence of morbidity. One of the leading causes of chronic illness and disability worldwide, stroke results in residual sensorimotor, cognition, and communication impairments. These impairments reduce over time, but few people have complete restoration of function. Hence, people with stroke-related disability do not resume pre-stroke levels of community participation (education; paid or volunteer work; civic, social, and religious activities; and leisure). Low levels of community participation are associated with inactivity, sedentary behavior, and social isolation, each contributors to cardiovascular disease, diabetes, obesity, pulmonary conditions, depression - and secondary stroke. These consequences are particularly problematic for people with low income who have limited resources.

Investigators at the University of Pittsburgh, Washington University, and the University of Illinois at Chicago have designed a self-management training program that uses social learning, motivational interviewing, and guided discovery to help people with mild to moderate stroke-related disability resume community participation, and to develop a strong network of social support. However, the combination of these elements has yet to be studied in people with chronic stroke-related disability who live with low income - one of the most vulnerable segments of the population. By partnering with the Community Research Fellows Program at Washington University and the Community PARTners Program at the University of Pittsburgh, this multi-site team seeks to design and implement a culturally-responsive program to promote community participation among people with stroke-related disability and low income. This new collaboration is the next logical step in the development and examination of community-based interventions to promote self-management and community participation after stroke.

The overall purpose of this research study is to examine the feasibility, safety, and acceptability of a multi-site community-based intervention to promote self-management of community participation after stroke, with a particular focus on the needs of people with low income. The study will also characterize variances in intervention response.

Conditions: Stroke
Being tested: ENGAGE
Keywords: disability, rehabilitation
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ENGAGEBehavioural
ENGAGE blends social learning, guided discovery and skill training focused on community participation

Study groups in NCT04019275
Study group	Role	What they receive
ENGAGE	Experimental	The intervention blends social learning, guided discovery, and skill training to promote community participation after stroke. The intervention is delivered in a group format and comprises group learning activities and individual action planning activities that address barriers to community participation after stroke. Receives: Behavioral: ENGAGE

What is being measured

The primary outcome is the main question the study is designed to answer.

Fidelity, Indicated by Score of 18 or Higher Out of 20 on the ENGAGE Fidelity Checklist
number of sessions attaining >= 90% adherence to protocol; an independent evaluator will assess a random 20% of sessions using the ENGAGE Fidelity Checklist; the Checklist has 20 items, each rated as 2=exceptional, 1=adherent, 0=not adherent
Measured: week 7
Acceptability, Indicated by Score 24 or Higher Out of 32 on the Client Satisfaction Questionnaire
Number of participants attaining >= 90% satisfaction; satisfaction is rated on 8 items with a 4-point Likert-type scale, 4 indicating very high satisfaction. Items are summed with total score ranging from 8 indicating poor satisfaction to 32 indicating very high satisfaction.
Measured: week 7
Adverse Events, Defined as Reported Injuries or Injurious Falls
Measured: week 7

Secondary outcomes (1)

Cohen's d Effect Size of the Change From Week 1 to Week 7 in PROMIS Ability to Participate in Social Roles
The PROMIS Ability to Participate in Social Roles scale measures difficulty participating in social roles and activities. Eight items are rated on a Liker-type scale from 1=always having difficulty to 5=never having difficulty. Raw total scores (range 8 to 40) are converted to standardized T-scores with a population mean of 50, with a standard deviation of 10. Higher T-scores are associated with less difficulty. A T-score of 40 is considered subclinical difficulty with ability to participate in social roles and activities.
A Cohen's d=.20 is considered a small effect size, d=.50 is considered a medium effect size, and d=.80 is considered a large effect size. A positive Cohen's d effect size indicates a higher score at week 7 than week 1. A negative Cohen's d effect size indicates a higher score at week 1 than week 7.
Measured: week 1 vs week 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201930 Dec 2022

First posted15 Jul 2019
Study start1 Sep 2019
Primary completion30 Jun 2022
Study completion30 Dec 2022

Why it stopped: The COVID pandemic impeded recruitment at two sites (Pitt 80% target recruitment, Wash U 70% target recruitment) and prohibited recruitment at one site (UIC). Study was terminated when funding was spent.

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 University of PittsburghThe 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04019275
Sponsor's protocol ID: PRO19030256
Other IDs: UL1TR001857, UL1TR002345
Status last verified: Feb 2024
First submitted: 11 Jul 2019
Last updated: 21 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ENGAGE Pilot Study: Promoting Participation and Health After Stroke
ClinicalTrials.gov ID: NCT04019275
Acronym / sponsor ID: PRO19030256
Conditions: Stroke
Keywords: disability, rehabilitation
Study type: Interventional
Recruitment status: TerminatedReason stopped: The COVID pandemic impeded recruitment at two sites (Pitt 80% target recruitment, Wash U 70% target recruitment) and prohibited recruitment at one site (UIC). Study was terminated when funding was spent.
Enrolment: 38 participants (actual)
Lead sponsor: University of PittsburghUniversity, hospital or other
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Study start: 1 Sep 2019 (actual)
Primary completion: 30 Jun 2022 (actual)
Study completion: 30 Dec 2022 (actual)
First posted: 15 Jul 2019 (actual)
Results: Posted 23 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ENGAGE	Experimental	Behavioral: ENGAGEThe intervention blends social learning, guided discovery, and skill training to promote community participation after stroke. The intervention is delivered in a group format and comprises group learning activities and individual action planning activities that address barriers to community participation after stroke.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

ages 18 and older
chronic stroke (minimum 3 months)
community-dwelling
mild to moderate stroke-related disability (NIHSS<=16)
restrictions in community participation (ACS <80% of pre-stroke activities)

Key exclusion criteria (6 listed)

currently receiving rehabilitation serves
dementia diagnosis
severe aphasia (BDAE=0 or 1)
current major depressive disorder (unless treated and in partial remission)
current bipolar or psychotic disorder

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
ENGAGEENGAGE blends social learning, guided discovery and skill training focused on community participation	Behavioural	ENGAGE

Primary outcome

Fidelity, Indicated by Score of 18 or Higher Out of 20 on the ENGAGE Fidelity Checklist
Time frame: week 7
number of sessions attaining >= 90% adherence to protocol; an independent evaluator will assess a random 20% of sessions using the ENGAGE Fidelity Checklist; the Checklist has 20 items, each rated as 2=exceptional, 1=adherent, 0=not adherent
Acceptability, Indicated by Score 24 or Higher Out of 32 on the Client Satisfaction Questionnaire
Time frame: week 7
Number of participants attaining >= 90% satisfaction; satisfaction is rated on 8 items with a 4-point Likert-type scale, 4 indicating very high satisfaction. Items are summed with total score ranging from 8 indicating poor satisfaction to 32 indicating very high satisfaction.
Adverse Events, Defined as Reported Injuries or Injurious Falls
Time frame: week 7

1 secondary outcome

Cohen's d Effect Size of the Change From Week 1 to Week 7 in PROMIS Ability to Participate in Social Roles
Time frame: week 1 vs week 7

Results and safety

Results posted to the registry on 23 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ENGAGE	30	24

Primary outcome: Fidelity, Indicated by Score of 18 or Higher Out of 20 on the ENGAGE Fidelity Checklist

Time frame: week 7. Number. Unit: sessions

Measure	ENGAGE n = 9
Value	4

Population analysed: Fidelity was observed for 4 randomly selected sessions from 24 total session, or 17% of group sessions involving 9 participants. After this point, fidelity assessment was halted due to the COVID pandemic.

Primary outcome: Acceptability, Indicated by Score 24 or Higher Out of 32 on the Client Satisfaction Questionnaire

Time frame: week 7. Count of participants. Unit: Participants

Measure	ENGAGE n = 23
Value	20

Population analysed: One participant did not complete the Client Satisfaction Questionnaire

Primary outcome: Adverse Events, Defined as Reported Injuries or Injurious Falls

Time frame: week 7. Count of participants. Unit: Participants

Measure	ENGAGE n = 24
Value	0

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 7 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ENGAGE	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Limitations and caveats (from the sponsor): The ENGAGE Fidelity Checklist was not finalized due to changes in procedures during the COVID pandemic. Thus, while 4 of 24 sessions involving 9 participants were assessed for fidelity, and all 4 sessions met criteria for fidelity, the method for assessing fidelity was still in development and was only applied to a limited sample of sessions. Data pertaining to this should be interpreted with caution.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Stroke

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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
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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.

Elizabeth R Skidmore, PhD principal investigator

University of Pittsburgh

Carolyn Baum, PhD principal investigator

Washington University School of Medicine

Joy Hammel, PhD principal investigator

University of Illinois Chicago

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ENGAGE in people with Stroke, run by University of Pittsburgh at 3 sites 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 7 inclusion and 6 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: stopped early, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 23 Jun 2023). 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?

Fidelity, Indicated by Score of 18 or Higher Out of 20 on the ENGAGE Fidelity Checklist (time frame: week 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04019275.

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 21 Feb 2024.