Trial Outcomes & Findings for Community Health Worker Assisted Task Specific and Cognitive Therapy at Home With Exposure After Stroke (NCT NCT06314308)
NCT ID: NCT06314308
Last Updated: 2026-04-20
Results Overview
This outcome is designed to measure intervention feasibility, which will take recruitment, retention, and fidelity of implementation into account. The participants who complete 100% of the study required procedures will be tallied.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
3 months
Results posted on
2026-04-20
Participant Flow
The study consented (enrolled) 30 participants. 22 out of 30 participants were assigned to the intervention after passing screening period.
Participant milestones
| Measure |
Intervention
Task Specific Training Task-Specific Training (TST) which is the repeated, active practice of a motor skill or activity that is meaningful to an individual with the goal of skill acquisition and retention will be provided over 5 sessions after initial an initial assessment by a physical therapist. Cognitive Behavioral Therapy (CBT) with exposure is a psychotherapeutic intervention that focuses on modifying individuals' thoughts and behavior guided through graded exposure will be guided by a psychologist.
CATCHES: At the baseline visit (T0), informed consent will be obtained, and baseline questionnaires and measurements completed. A physical activity monitor will be provided. After discharge, Task Specific Training guided by Cognitive Behavioral Therapy with Exposure delivered over 7 one-hour sessions including two intake sessions by specialists and five follow up sessions delivered by CHWs individually at home over 3 months. After the final session at 12 weeks (about 3 months), participants will complete a study end visit (T1) which will include follow up questionnaires and measurements.
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Intervention
Task Specific Training Task-Specific Training (TST) which is the repeated, active practice of a motor skill or activity that is meaningful to an individual with the goal of skill acquisition and retention will be provided over 5 sessions after initial an initial assessment by a physical therapist. Cognitive Behavioral Therapy (CBT) with exposure is a psychotherapeutic intervention that focuses on modifying individuals' thoughts and behavior guided through graded exposure will be guided by a psychologist.
CATCHES: At the baseline visit (T0), informed consent will be obtained, and baseline questionnaires and measurements completed. A physical activity monitor will be provided. After discharge, Task Specific Training guided by Cognitive Behavioral Therapy with Exposure delivered over 7 one-hour sessions including two intake sessions by specialists and five follow up sessions delivered by CHWs individually at home over 3 months. After the final session at 12 weeks (about 3 months), participants will complete a study end visit (T1) which will include follow up questionnaires and measurements.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Community Health Worker Assisted Task Specific and Cognitive Therapy at Home With Exposure After Stroke
Baseline characteristics by cohort
| Measure |
Intervention
n=22 Participants
Task Specific Training Task-Specific Training (TST) which is the repeated, active practice of a motor skill or activity that is meaningful to an individual with the goal of skill acquisition and retention will be provided over 5 sessions after initial an initial assessment by a physical therapist. Cognitive Behavioral Therapy (CBT) with exposure is a psychotherapeutic intervention that focuses on modifying individuals' thoughts and behavior guided through graded exposure will be guided by a psychologist.
CATCHES: At the baseline visit (T0), informed consent will be obtained, and baseline questionnaires and measurements completed. A physical activity monitor will be provided. After discharge, Task Specific Training guided by Cognitive Behavioral Therapy with Exposure delivered over 7 one-hour sessions including two intake sessions by specialists and five follow up sessions delivered by CHWs individually at home over 3 months. After the final session at 12 weeks (about 3 months), participants will complete a study end visit (T1) which will include follow up questionnaires and measurements.
|
|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 11 • n=129 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=129 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=129 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=129 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=129 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=129 Participants
|
PRIMARY outcome
Timeframe: 3 monthsThis outcome is designed to measure intervention feasibility, which will take recruitment, retention, and fidelity of implementation into account. The participants who complete 100% of the study required procedures will be tallied.
Outcome measures
| Measure |
Intervention
n=22 Participants
Task Specific Training Task-Specific Training (TST) which is the repeated, active practice of a motor skill or activity that is meaningful to an individual with the goal of skill acquisition and retention will be provided over 5 sessions after initial an initial assessment by a physical therapist. Cognitive Behavioral Therapy (CBT) with exposure is a psychotherapeutic intervention that focuses on modifying individuals' thoughts and behavior guided through graded exposure will be guided by a psychologist.
CATCHES: At the baseline visit (T0), informed consent will be obtained, and baseline questionnaires and measurements completed. A physical activity monitor will be provided. After discharge, Task Specific Training guided by Cognitive Behavioral Therapy with Exposure delivered over 7 one-hour sessions including two intake sessions by specialists and five follow up sessions delivered by CHWs individually at home over 3 months. After the final session at 12 weeks (about 3 months), participants will complete a study end visit (T1) which will include follow up questionnaires and measurements.
|
|---|---|
|
Percentage of Intervention Completers to Demonstrate Feasibility
|
19 Participants
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: 18 out of 22 participants completed the questionnaire up to 3 months.
This outcome is designed to measure the change in fear of falling. This is a 16-item self-reported questionnaire with a score range of 1-100. 1 = no confidence and 100 = completely confident. The higher the score, the lesser the fear. Total scores are calculated by summing items (16-1600 range) and dividing by 16.
Outcome measures
| Measure |
Intervention
n=18 Participants
Task Specific Training Task-Specific Training (TST) which is the repeated, active practice of a motor skill or activity that is meaningful to an individual with the goal of skill acquisition and retention will be provided over 5 sessions after initial an initial assessment by a physical therapist. Cognitive Behavioral Therapy (CBT) with exposure is a psychotherapeutic intervention that focuses on modifying individuals' thoughts and behavior guided through graded exposure will be guided by a psychologist.
CATCHES: At the baseline visit (T0), informed consent will be obtained, and baseline questionnaires and measurements completed. A physical activity monitor will be provided. After discharge, Task Specific Training guided by Cognitive Behavioral Therapy with Exposure delivered over 7 one-hour sessions including two intake sessions by specialists and five follow up sessions delivered by CHWs individually at home over 3 months. After the final session at 12 weeks (about 3 months), participants will complete a study end visit (T1) which will include follow up questionnaires and measurements.
|
|---|---|
|
Change in Activities-specific Balance Confidence Scale Score
|
27.3 score on a scale
Interval 17.5 to 37.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 3 monthsPopulation: 19 out of 22 participants completed the test up to 3 months.
This exploratory outcome is to measure change in physical function. The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk in older adults. The test involves recording the length of time it takes a participant to stand from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. Change in time to perform the test will be assessed. Measured in number of second taken to complete the test. When the number is negative, it means that the participant took less time to complete the test at 3 months compared to baseline.
Outcome measures
| Measure |
Intervention
n=19 Participants
Task Specific Training Task-Specific Training (TST) which is the repeated, active practice of a motor skill or activity that is meaningful to an individual with the goal of skill acquisition and retention will be provided over 5 sessions after initial an initial assessment by a physical therapist. Cognitive Behavioral Therapy (CBT) with exposure is a psychotherapeutic intervention that focuses on modifying individuals' thoughts and behavior guided through graded exposure will be guided by a psychologist.
CATCHES: At the baseline visit (T0), informed consent will be obtained, and baseline questionnaires and measurements completed. A physical activity monitor will be provided. After discharge, Task Specific Training guided by Cognitive Behavioral Therapy with Exposure delivered over 7 one-hour sessions including two intake sessions by specialists and five follow up sessions delivered by CHWs individually at home over 3 months. After the final session at 12 weeks (about 3 months), participants will complete a study end visit (T1) which will include follow up questionnaires and measurements.
|
|---|---|
|
Change in Timed Up and Go Test Score
|
-7.3 seconds
Interval -14.3 to -0.4
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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