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ENGAGE Pilot Study: Promoting Participation and Health After Stroke
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Stroke | Behavioral: ENGAGE | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | ENGAGE Pilot Study: Promoting Participation and Health After Stroke |
| Actual Study Start Date : | September 1, 2019 |
| Estimated Primary Completion Date : | December 30, 2021 |
| Estimated Study Completion Date : | December 30, 2021 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: ENGAGE
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.
|
Behavioral: ENGAGE
ENGAGE blends social learning, guided discovery and skill training focused on community participation
|
- 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 scale, 4 indicating very high satisfaction; items are summed with total a total score of 32 indicating very high satisfaction;
- Adverse Events, defined as reported injuries or injurious falls [ Time Frame: week 7 ]<3% of participants reporting adverse events; investigators will tally the number of participants reporting injuries or injurious falls during the 6 week intervention;
- Change in PROMIS Ability to Participate in Social Roles from week 1 to week 7 [ Time Frame: week 1 vs week 7 ]Cohen's d effect size of change >.20; the PROMIS measure is 8 items rated on a 5-point likert scale; 5=never any difficulty; scores are summed, with total scores 40 indicating high ability to participate;
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
| Contact: Elizabeth R Skidmore, PhD | 412-383-6617 | skidmore@pitt.edu | |
| Contact: Laura F Waterstram, MOT | 412-383-1055 | lfw11@pitt.edu |
| United States, Illinois | |
| University of Illinois at Chicago | Not yet recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Joy Hammel, PhD 312-996-3513 hammel@uic.edu | |
| United States, Missouri | |
| Washington University | Recruiting |
| Saint Louis, Missouri, United States, 63108 | |
| Contact: Carolyn Baum, PhD 314-286-1618 baumc@wustl.edu | |
| United States, Pennsylvania | |
| University of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15260 | |
| Contact: Elizabeth R Skidmore, PhD 412-383-6617 skidmore@pitt.edu | |
| Contact: Laura F Waterstram, MOT 412-383-1055 lfw11@pitt.edu | |
| Principal Investigator: | Elizabeth R Skidmore, PhD | University of Pittsburgh | |
| Principal Investigator: | Carolyn Baum, PhD | Washington University School of Medicine | |
| Principal Investigator: | Joy Hammel, PhD | University of Illinois at Chicago |
| Tracking Information | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 11, 2019 | |||||||||
| First Posted Date ICMJE | July 15, 2019 | |||||||||
| Last Update Posted Date | January 7, 2021 | |||||||||
| Actual Study Start Date ICMJE | September 1, 2019 | |||||||||
| Estimated Primary Completion Date | December 30, 2021 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures ICMJE |
Change in PROMIS Ability to Participate in Social Roles from week 1 to week 7 [ Time Frame: week 1 vs week 7 ] Cohen's d effect size of change >.20; the PROMIS measure is 8 items rated on a 5-point likert scale; 5=never any difficulty; scores are summed, with total scores 40 indicating high ability to participate;
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| Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | ENGAGE Pilot Study: Promoting Participation and Health After Stroke | |||||||||
| Official Title ICMJE | ENGAGE Pilot Study: Promoting Participation and Health After Stroke | |||||||||
| Brief Summary | 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. | |||||||||
| 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. |
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| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Not Applicable | |||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Stroke | |||||||||
| Intervention ICMJE | Behavioral: ENGAGE
ENGAGE blends social learning, guided discovery and skill training focused on community participation
|
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| Study Arms ICMJE | Experimental: ENGAGE
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.
Intervention: Behavioral: ENGAGE
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Recruiting | |||||||||
| Estimated Enrollment ICMJE |
60 | |||||||||
| Original Estimated Enrollment ICMJE | Same as current | |||||||||
| Estimated Study Completion Date ICMJE | December 30, 2021 | |||||||||
| Estimated Primary Completion Date | December 30, 2021 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT04019275 | |||||||||
| Other Study ID Numbers ICMJE | PRO19030256 UL1TR001857 ( U.S. NIH Grant/Contract ) UL1TR002345 ( U.S. NIH Grant/Contract ) |
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| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Elizabeth R. Skidmore, PhD, OTR/L, University of Pittsburgh | |||||||||
| Study Sponsor ICMJE | University of Pittsburgh | |||||||||
| Collaborators ICMJE | National Institutes of Health (NIH) | |||||||||
| Investigators ICMJE |
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| PRS Account | University of Pittsburgh | |||||||||
| Verification Date | January 2021 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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