Stroke
Conditions
Keywords
disability, rehabilitation
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.
Interventions
BEHAVIORALENGAGE
ENGAGE blends social learning, guided discovery and skill training focused on community participation
Sponsors
National Center for Advancing Translational Sciences (NCATS)
University of Pittsburgh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fidelity, Indicated by Score of 18 or Higher Out of 20 on the ENGAGE Fidelity Checklist | 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 | 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 | week 7 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cohen's d Effect Size of the Change From Week 1 to Week 7 in PROMIS Ability to Participate in Social Roles | week 1 vs week 7 | 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. |
Countries
United States
Participant flow
Pre-assignment details
38 participants provided informed consent and were eligible for the study. 8 participants withdrew before starting intervention (3 due to scheduling, 3 due to difficulty with accessing technology for the intervention, 1 was hospitalized, 1 withdrew at family request). 30 participants started the protocol.
Participants by arm
| Arm | Count |
|---|---|
| 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.
ENGAGE: ENGAGE blends social learning, guided discovery and skill training focused on community participation | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | ENGAGE |
|---|---|
| Age, Continuous | 62.28 years STANDARD_DEVIATION 12.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| PROMIS Ability to Participate in Social Roles | 43.48 T-score STANDARD_DEVIATION 7.34 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
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.
Time frame: week 7
Population: One participant did not complete the Client Satisfaction Questionnaire
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ENGAGE | Acceptability, Indicated by Score 24 or Higher Out of 32 on the Client Satisfaction Questionnaire | 20 Participants |
Primary
Adverse Events, Defined as Reported Injuries or Injurious Falls
Time frame: week 7
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ENGAGE | Adverse Events, Defined as Reported Injuries or Injurious Falls | 0 Participants |
Primary
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
Time frame: week 7
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ENGAGE | Fidelity, Indicated by Score of 18 or Higher Out of 20 on the ENGAGE Fidelity Checklist | 4 sessions |
Secondary
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.
Time frame: week 1 vs week 7
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ENGAGE | Cohen's d Effect Size of the Change From Week 1 to Week 7 in PROMIS Ability to Participate in Social Roles | 0.38 Cohen's d effect size |