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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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Adults with stroke-related disability spend more time sedentary than adults without stroke-related disability, which places them at risk for poor cardiovascular health outcomes. Few interventions are designed to reduce post-stroke sedentary time.
The purpose of this research is to test whether the teleABLE (Activating Behavior for Lasting Engagement) Intervention is feasible and acceptable to adults within the first 12 months post-stroke. The hypothesis is that teleABLE can be feasibly delivered using videoconferencing within the first 12 months post-stroke. 10 participants will complete assessments and activity monitoring (activPAL micro3) at 0 (baseline) and 8 (post-intervention)-weeks. Participants will complete 12 sessions of the teleABLE intervention.
Findings from this study will be used to guide the intervention protocol in the planned next phase of this research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| teleABLE | Experimental | Participants will complete 12 teleABLE sessions via videoconferencing, guided by an intervention therapist and participant workbook. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| teleABLE | Behavioral | Participants will be guided to self-monitor their daily activities, schedule personally meaningful non-sedentary activities, collaboratively problem solve to overcome barriers to the activity, and self-assess their progress. Participants may be asked to self-monitor their activity levels and complete planned activities between sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | The count of treatment-related serious (e.g. injurious) and non-serious (e.g. fall without injury) adverse events that occur during intervention delivery will be reported. | week 2 through week 7 |
| Participant Satisfaction | Assessed by the Client Satisfaction Questionnaire-8. This is an 8-item questionnaire with each item ranked on an 1 to 4 Likert-type scale. We will compute the mean score across all items. The possible range is 1 to 4, with high scores indicating high satisfaction. | week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Participation Restrictions | Assessed by the Activity Card Sort 3. This is a 100-item tool during which participants indicate whether they did the activity prior to their stroke, continue to do the activity since their stroke, or have given up the activity since their stroke. Change in the proportion of activities retained will be reported. | week 0 to week 8 |
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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 |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | teleABLE | Participants will complete 12 teleABLE sessions via videoconferencing, guided by an intervention therapist and participant workbook. teleABLE: Participants will be guided to self-monitor their daily activities, schedule personally meaningful non-sedentary activities, collaboratively problem solve to overcome barriers to the activity, and self-assess their progress. Participants may be asked to self-monitor their activity levels and complete planned activities between sessions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | teleABLE | Participants will complete 12 teleABLE sessions via videoconferencing, guided by an intervention therapist and participant workbook. teleABLE: Participants will be guided to self-monitor their daily activities, schedule personally meaningful non-sedentary activities, collaboratively problem solve to overcome barriers to the activity, and self-assess their progress. Participants may be asked to self-monitor their activity levels and complete planned activities between sessions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Incidence of Treatment-Emergent Adverse Events | The count of treatment-related serious (e.g. injurious) and non-serious (e.g. fall without injury) adverse events that occur during intervention delivery will be reported. | Posted | Number | adverse events | week 2 through week 7 |
|
8 weeks
Adverse events were queried using a questionnaire at the Week 8 assessment timepoint. If the treating occupational therapist became aware of an adverse event during an intervention session, it was reported at the time it was discovered.
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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 | teleABLE | Participants will complete 12 teleABLE sessions via videoconferencing, guided by an intervention therapist and participant workbook. teleABLE: Participants will be guided to self-monitor their daily activities, schedule personally meaningful non-sedentary activities, collaboratively problem solve to overcome barriers to the activity, and self-assess their progress. Participants may be asked to self-monitor their activity levels and complete planned activities between sessions. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle soreness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Emily Kringle | University of Minnesota | (612) 624-8994 | ekringle@umn.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 | Jul 21, 2023 | Jun 9, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 27, 2023 | Jun 9, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| D000083302 | Hemorrhagic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Change in Health-Related Quality of Life | Assessed by the EuroQol-5 Dimension-5 Level. This is a 5-item self-report questionnaire with each item scored on a 1 to 5 scale. Scores are converted to Index Scores following published procedures (possible range -1 to 1), with high scores indicating high quality of life. | week 0 to week 8 |
| Change in Sedentary Minutes | Assessed using the activPAL micro3 monitor following a 7-day wear protocol. The mean daily minutes of sitting time accumulated in bouts of 30 minutes or more will be computed for each time point. Change in mean daily minutes of sitting time accumulated in bouts of 30 minutes or more will be reported. | week 0 to week 8 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | Participant Satisfaction | Assessed by the Client Satisfaction Questionnaire-8. This is an 8-item questionnaire with each item ranked on an 1 to 4 Likert-type scale. We will compute the mean score across all items. The possible range is 1 to 4, with high scores indicating high satisfaction. | Posted | Mean | Standard Deviation | score on a scale of 1 to 4 | week 8 |
|
|
|
| Secondary | Change in Participation Restrictions | Assessed by the Activity Card Sort 3. This is a 100-item tool during which participants indicate whether they did the activity prior to their stroke, continue to do the activity since their stroke, or have given up the activity since their stroke. Change in the proportion of activities retained will be reported. | Posted | Median | Inter-Quartile Range | change in % retained activities | week 0 to week 8 |
|
|
|
| Secondary | Change in Health-Related Quality of Life | Assessed by the EuroQol-5 Dimension-5 Level. This is a 5-item self-report questionnaire with each item scored on a 1 to 5 scale. Scores are converted to Index Scores following published procedures (possible range -1 to 1), with high scores indicating high quality of life. | Posted | Median | Inter-Quartile Range | change score on a scale of -1 to 1 | week 0 to week 8 |
|
|
|
| Secondary | Change in Sedentary Minutes | Assessed using the activPAL micro3 monitor following a 7-day wear protocol. The mean daily minutes of sitting time accumulated in bouts of 30 minutes or more will be computed for each time point. Change in mean daily minutes of sitting time accumulated in bouts of 30 minutes or more will be reported. | n=1 participant lost to follow-up n=3 participants with <6 valid activPAL days at 1 or more timepoints | Posted | Median | Inter-Quartile Range | change in sedentary minutes | week 0 to week 8 |
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| 0 |
| 10 |
| 0 |
| 10 |
| 2 |
| 10 |
| Skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |