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| ID | Type | Description | Link |
|---|---|---|---|
| P20GM109040-06 | U.S. NIH Grant/Contract | View source |
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Due to COVID-19 and loss of funding
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of General Medical Sciences (NIGMS) | NIH |
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Stroke survivors with arm paresis because of stroke use their "good" arm for daily activities, but in doing so may be self-limiting their own recovery of the "bad" arm. Traditional models of stroke rehabilitation fail to fully engage the survivor and care partner(s) in actively planning post-discharge habits that improve their capacity to live well over their entire lives. This study will test a cutting-edge in-person therapy + online training program designed to progressively transfer the responsibility of driving post-stroke recovery from the therapist to the survivor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| e learning+therapy (TEAACH) | Experimental | TEAACH-Training to Empower Activity-dependent plasticity-based Arm-use habits in the Community and at Home |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEAACH | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Health Literacy From Baseline to 3 Months | 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. | Baseline Visit and 3 months |
| Change in Self Management Skills From Baseline to 3 Months | 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. | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Self-Efficacy for Managing Daily Activities From Baseline to 3 Months and 5 Months | 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. | Baseline Visit, 3 months and 5 months |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Woodbury, PT, PhD | Medical University of SC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Health Literacy From Baseline to 3 Months | 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. | 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. | Posted | Baseline Visit and 3 months |
|
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed
The first subject was enrolled in August 2019 but study procedures could not begin until a cohort was enrolled as per study design. Hence, because of the covid shut down in March 2020 we did not enroll a complete cohort and the study stopped prior to beginning the group-related study procedures. Therefore, All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Woodbury, PhD | Medical University of South Carolina | 843-792-0651 | woodbuml@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 14, 2019 | Oct 7, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 14, 2019 | Mar 15, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Change in Social Isolation From Baseline to 3 Months and 5 Months |
Social Isolation will be assessed using the NIH PROMIS Social Isolation assessment. Minimum score = 0, Maximum score = 8. Higher numbers indicate less social isolation. |
| Baseline Visit, 3 months & 5 months |
| Change in Emotional Support From Baseline to 3 Months and 5 Months | Emotional Support will be assessed using the NIH PROMIS Emotional Support assessment. Minimum score = 0, Maximum score = 8. Higher numbers indicate greater emotional support. | Baseline Visit, 3 months (Post Treatment+/- 3 days), & 5 months (Follow up +/- 3 days) |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
| Primary | Change in Self Management Skills From Baseline to 3 Months | 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. | 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. | Posted | Baseline and 3 months |
|
|
| Secondary | Change in Self-Efficacy for Managing Daily Activities From Baseline to 3 Months and 5 Months | 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. | 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. | Posted | Baseline Visit, 3 months and 5 months |
|
|
| Secondary | Change in Social Isolation From Baseline to 3 Months and 5 Months | Social Isolation will be assessed using the NIH PROMIS Social Isolation assessment. Minimum score = 0, Maximum score = 8. Higher numbers indicate less social isolation. | 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. | Posted | Baseline Visit, 3 months & 5 months |
|
|
| Secondary | Change in Emotional Support From Baseline to 3 Months and 5 Months | Emotional Support will be assessed using the NIH PROMIS Emotional Support assessment. Minimum score = 0, Maximum score = 8. Higher numbers indicate greater emotional support. | 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. | Posted | Baseline Visit, 3 months (Post Treatment+/- 3 days), & 5 months (Follow up +/- 3 days) |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |