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| ID | Type | Description | Link |
|---|---|---|---|
| K23HL159240 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The goal of this clinical trial to test whether a remotely delivered behavioral activation-based intervention called "teleABLE" works better than a health education intervention for (1) reducing sitting time and (2) improving health-related quality among adults who were diagnosed with stroke within the past 12 months.
Participants in this study will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| teleABLE | Experimental | Participants meet with a study therapist 2x/week for 6 weeks (12 sessions) to complete behavioral activation focused on adding personally meaningful non-sedentary activities during times when they typically spend sitting. All sessions are delivered remotely using Zoom videoconferencing. |
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| Health Education | Active Comparator | Participants meet with a study therapist 1x/week for 6 weeks (6 sessions) to review fact sheets focused on healthy lifestyles after stroke. All sessions are delivered remotely using Zoom videoconferencing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| teleABLE (telehealth-delivered Activating Behavior for Lasting Engagement) | Behavioral | teleABLE uses behavioral activation to build personally meaningful non-sedentary throughout the day. This is accomplished using a global strategy, the ICAN Planning Process, which guides participants through activity scheduling, activity monitoring, self-assessment, and collaborative problem solving. |
| Measure | Description | Time Frame |
|---|---|---|
| Between-group difference in change scores on health-related quality of life | European Quality of Life 5-Dimension 5-Level (EuroQOL-5D-5L) change score. The possible range on this tool is -1 (worst) to 1 (best). | Week 0 to Week 8 |
| Between-group difference in change in sedentary behavior | Change in mean minutes per day spent in prolonged sedentary time (accumulated in bouts of 30 minutes or more) measured using the activPAL micro4 (7-day wear protocol) | Week 0 to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Between-group difference in change in sedentary behavior | Change in mean minutes per day spent in prolonged sedentary time (accumulated in bouts of 30 minutes or more) measured using the activPAL micro4 (7-day wear protocol) | Week 0 to Week 24 |
| Between-group difference in change scores on health-related quality of life |
| Measure | Description | Time Frame |
|---|---|---|
| Between-group difference in change in step count | Mean daily step count measured using the activPAL micro4 (7-day wear protocol) | Week 0 to Week 8 |
| Between-group difference in change in step count | Mean daily step count measured using the activPAL micro4 (7-day wear protocol) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily Kringle, PhD, OTR/L | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Kinesiology, University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D057185 | Sedentary Behavior |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Health Education | Other | Health Education provides information about stroke using factsheets from the American Heart Association and reflection questions that support participants in applying the information. |
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European Quality of Life 5-Dimension 5-Level (EuroQOL-5D-5L) change score. The possible range on this tool is -1 (worst) to 1 (best). |
| Week 0 to Week 24 |
| Week 0 to Week 24 |
| Between-group difference in change in total activity retention | Change in the proportion of total activities retained measured using the Activity Card Sort (ACS3) | Week 0 to Week 8 |
| Between-group difference in change in total activity retention | Change in the proportion of total activities retained measured using the Activity Card Sort (ACS3) | Week 0 to Week 24 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |