Trial Outcomes & Findings for ENGAGE Pilot Study: Promoting Participation and Health After Stroke (NCT NCT04019275)
NCT ID: NCT04019275
Last Updated: 2024-02-21
Results Overview
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
TERMINATED
NA
38 participants
week 7
2024-02-21
Participant Flow
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.
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ENGAGE Pilot Study: Promoting Participation and Health After Stroke
Baseline characteristics by cohort
| Measure |
ENGAGE
n=30 Participants
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
|
|---|---|
|
Age, Continuous
|
62.28 years
STANDARD_DEVIATION 12.10 • n=39 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=39 Participants
|
|
PROMIS Ability to Participate in Social Roles
|
43.48 T-score
STANDARD_DEVIATION 7.34 • n=39 Participants
|
PRIMARY outcome
Timeframe: week 7Population: 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.
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
Outcome measures
| Measure |
ENGAGE
n=4 sessions
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
|
|---|---|
|
Fidelity, Indicated by Score of 18 or Higher Out of 20 on the ENGAGE Fidelity Checklist
|
4 sessions
|
PRIMARY outcome
Timeframe: week 7Population: One participant did not complete 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.
Outcome measures
| Measure |
ENGAGE
n=23 Participants
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
|
|---|---|
|
Acceptability, Indicated by Score 24 or Higher Out of 32 on the Client Satisfaction Questionnaire
|
20 Participants
|
PRIMARY outcome
Timeframe: week 7Outcome measures
| Measure |
ENGAGE
n=24 Participants
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
|
|---|---|
|
Adverse Events, Defined as Reported Injuries or Injurious Falls
|
0 Participants
|
SECONDARY outcome
Timeframe: week 1 vs week 7The 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.
Outcome measures
| Measure |
ENGAGE
n=24 Participants
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
|
|---|---|
|
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
Interval -0.11 to 0.94
|
Adverse Events
ENGAGE
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place