Trial Outcomes & Findings for E-learning+ Rehab Therapy (NCT NCT04245449)
NCT ID: NCT04245449
Last Updated: 2023-03-17
Results Overview
Health Literacy will be assessed via a standardize 18-item test designed to assess an adult's ability to read and understand common medical terms. Minimum = 0, Maximum = 18. Higher scores indicate greater health literacy.
TERMINATED
NA
7 participants
Baseline Visit and 3 months
2023-03-17
Participant Flow
Participants were enrolled however the study is designed so that cohorts start together. Study procedures did not start until a group of subjects were enrolled. Due to Covid shutting the study down study procedures did not start.
Participant milestones
| Measure |
e Learning+Therapy (TEAACH)
TEAACH-Training to Empower Activity-dependent plasticity-based Arm-use habits in the Community and at Home
TEAACH: TEAACH e-learning: 3-months of online educational modules include neuroscience education (based on an effective pain educational model37) to improve patient self-efficacy, and strategy-training38 to improve patients' problem-solving abilities for at-home arm use. The course is live on the MUSC MoodleCE platform.
TEAACH in-clinic therapy: 24 in-clinic sessions; 3 times/week for 4 weeks (month 1), 2 times/week for 4 weeks (month 2) and 1 time/week for 4 weeks (month 3) with 200 movement repetitions per session. In our RCTs, this therapy dose required \~1.0-1.5 hours/session. A critical element of TEAACH is the focus on linking in-clinic therapy to out-of-clinic real world paretic arm use via MoodleCE Learning Activities.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
e Learning+Therapy (TEAACH)
TEAACH-Training to Empower Activity-dependent plasticity-based Arm-use habits in the Community and at Home
TEAACH: TEAACH e-learning: 3-months of online educational modules include neuroscience education (based on an effective pain educational model37) to improve patient self-efficacy, and strategy-training38 to improve patients' problem-solving abilities for at-home arm use. The course is live on the MUSC MoodleCE platform.
TEAACH in-clinic therapy: 24 in-clinic sessions; 3 times/week for 4 weeks (month 1), 2 times/week for 4 weeks (month 2) and 1 time/week for 4 weeks (month 3) with 200 movement repetitions per session. In our RCTs, this therapy dose required \~1.0-1.5 hours/session. A critical element of TEAACH is the focus on linking in-clinic therapy to out-of-clinic real world paretic arm use via MoodleCE Learning Activities.
|
|---|---|
|
Overall Study
COVID shutdown
|
7
|
Baseline Characteristics
E-learning+ Rehab Therapy
Baseline characteristics by cohort
| Measure |
e Learning+Therapy (TEAACH)
n=7 Participants
TEAACH-Training to Empower Activity-dependent plasticity-based Arm-use habits in the Community and at Home
TEAACH: TEAACH e-learning: 3-months of online educational modules include neuroscience education (based on an effective pain educational model37) to improve patient self-efficacy, and strategy-training38 to improve patients' problem-solving abilities for at-home arm use. The course is live on the MUSC MoodleCE platform.
TEAACH in-clinic therapy: 24 in-clinic sessions; 3 times/week for 4 weeks (month 1), 2 times/week for 4 weeks (month 2) and 1 time/week for 4 weeks (month 3) with 200 movement repetitions per session. In our RCTs, this therapy dose required \~1.0-1.5 hours/session. A critical element of TEAACH is the focus on linking in-clinic therapy to out-of-clinic real world paretic arm use via MoodleCE Learning Activities.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline Visit and 3 monthsPopulation: Although the first subject was enrolled in August 2019, the Project was designed so that a cohort started together. In other words, the study team could not start study procedures until we had a group of subjects enrolled. Hence, although the first participant was enrolled in August, the study team was not able to start the study, because of the covid shut down in March prior to beginning the group related study procedures.
Health Literacy will be assessed via a standardize 18-item test designed to assess an adult's ability to read and understand common medical terms. Minimum = 0, Maximum = 18. Higher scores indicate greater health literacy.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: Although the first subject was enrolled in August 2019, the Project was designed so that a cohort started together. In other words, the study team could not start study procedures until we had a group of subjects enrolled. Hence, although the first participant was enrolled in August, the study team was not able to start the study, because of the covid shut down in March prior to beginning the group related study procedures.
Participants' ability to manage their chronic condition (their stroke) will be assessed qualitatively using interview questions. Participants' narratives will be analyzed and reported as a description of how their own skills have changed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline Visit, 3 months and 5 monthsPopulation: Although the first subject was enrolled in August 2019, the Project was designed so that a cohort started together. In other words, the study team could not start study procedures until we had a group of subjects enrolled. Hence, although the first participant was enrolled in August, the study team was not able to start the study, because of the covid shut down in March prior to beginning the group related study procedures.
Self-Efficacy will be assessed using the NIH PROMIS Self-Efficacy for Managing Daily Activities assessment. Minimum score = 0, Maximum score = 8. Higher numbers indicate greater self efficacy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline Visit, 3 months & 5 monthsPopulation: Although the first subject was enrolled in August 2019, the Project was designed so that a cohort started together. In other words, the study team could not start study procedures until we had a group of subjects enrolled. Hence, although the first participant was enrolled in August, the study team was not able to start the study, because of the covid shut down in March prior to beginning the group related study procedures.
Social Isolation will be assessed using the NIH PROMIS Social Isolation assessment. Minimum score = 0, Maximum score = 8. Higher numbers indicate less social isolation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline Visit, 3 months (Post Treatment+/- 3 days), & 5 months (Follow up +/- 3 days)Population: Although the first subject was enrolled in August 2019, the Project was designed so that a cohort started together. In other words, the study team could not start study procedures until we had a group of subjects enrolled. Hence, although the first participant was enrolled in August, the study team was not able to start the study, because of the covid shut down in March prior to beginning the group related study procedures.
Emotional Support will be assessed using the NIH PROMIS Emotional Support assessment. Minimum score = 0, Maximum score = 8. Higher numbers indicate greater emotional support.
Outcome measures
Outcome data not reported
Adverse Events
e Learning+Therapy (TEAACH)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michelle Woodbury, PhD
Medical University of South Carolina
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place