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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD114732-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Washington | OTHER |
| National Institutes of Health (NIH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The overall goal of this proposed study is to evaluate the efficacy of a small-group, stroke-specific, self-management program delivered via telehealth to improve self-efficacy, activity performance, and quality of life in individuals with sub-acute stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Improving Participation after Stroke Self-Management Program (IPASS) | Experimental | The IPASS-R intervention consists of 6 weekly 90-minute sessions delivered by an occupational therapist and stroke survivor peer facilitator. All sessions will be delivered remotely via videoconferencing. |
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| Chronic Disease Self-Management Program (CDSMP) | Active Comparator | The CDSMP will consist of 6, weekly 90-minute sessions. All sessions will be delivered remotely via videoconferencing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Improving Participation after Stroke Self-Management Program (IPASS) | Behavioral | The IPASS-R program is a group-based self-management intervention that aims to improve problem-solving, action-planning, and resource utilization skills for improved community living and participation. The Activity-Barriers-Changes-Doing-Evaluation (ABCDE) framework is a user friendly problem-solving and goal setting framework that is used repetitively in each session throughout the program. Participants are guided to identify (1) an activity that they want to improve or re-engage in (A); (2) individual and environmental barriers that hinder their engagement (B); (3) changes that they can make to deal with the barriers and improve their engagement (C); and (4) an action plan to pursue (D). After the action plan, participants come back in the next session and evaluate their performance in following through on their plans (E). |
| Measure | Description | Time Frame |
|---|---|---|
| Canadian Occupational Performance Measure (COPM) Performance | Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance. | Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32) |
| Canadian Occupational Performance Measure (COPM) Satisfaction | Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean higher satisfaction. | Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32) |
| Participation Strategies Self-Efficacy Scale (PS-SES) | Self-report measure of self-efficacy in using participation strategies. The subject rates confidence across 35 items within six subscales: (1) managing home participation, (2) staying organized, (3) planning and managing community participation, (4) managing work and productivity), (5) managing communication, and (6) advocating for resources. Range of scores from 35-350. Higher scores indicate greater self-efficacy. | Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32) |
| Measure | Description | Time Frame |
|---|---|---|
| In home activity level as measured by sensor system | average hourly percentage of time spent engaged in activity | Duration of study (from baseline assessment (week 0) to 6-month follow-up assessment) |
| Community engagement as measured by sensor system |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna E Boone, PhD, OTR/L | Contact | 5738827023 | booneae@umsystem.edu | |
| Juliana H. Earwood, OTD, OTR/L | Contact | 5738846681 | jmhudson@health.missouri.edu |
| Name | Affiliation | Role |
|---|---|---|
| Anna E Boone, PhD, OTR/L | University of Missouri Occupational Therapy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri | Recruiting | Columbia | Missouri | 65211 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15733048 | Background | Jette DU, Latham NK, Smout RJ, Gassaway J, Slavin MD, Horn SD. Physical therapy interventions for patients with stroke in inpatient rehabilitation facilities. Phys Ther. 2005 Mar;85(3):238-48. | |
| 27469998 | Background | Sakakibara BM, Kim AJ, Eng JJ. A Systematic Review and Meta-Analysis on Self-Management for Improving Risk Factor Control in Stroke Patients. Int J Behav Med. 2017 Feb;24(1):42-53. doi: 10.1007/s12529-016-9582-7. |
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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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| University of Illinois at Chicago |
| OTHER |
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All outcomes assessors will be blinded to participant study group assignment.
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| Chronic Disease Self-Management Program (CDSMP) | Behavioral | The program is facilitated by two trained leaders in small groups in a community setting with individuals who have chronic health problems and will follow the CDSMP protocol. Participants receive education on various health-related topics applicable to a range of chronic conditions, share experiences, and support one another. |
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Time outside the home as measured by time between door sensor activations
| Duration of study (from baseline assessment (week 0) to 6-month follow-up assessment) |
| Stroke Impact Scale participation domain | Measures perceived stroke recovery/quality of life. Range of scores 0-100. Higher scores indicate higher performance. | Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32) |
| Assessment of Life Habits (LIFE-H) | Measures self-reported participation in daily activities by measuring total score across 6 domains. Score range of 0 to 9 with higher scores indicating better performance. | Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32) |
| 27545611 | Background | Fryer CE, Luker JA, McDonnell MN, Hillier SL. Self management programmes for quality of life in people with stroke. Cochrane Database Syst Rev. 2016 Aug 22;2016(8):CD010442. doi: 10.1002/14651858.CD010442.pub2. |
| 29878691 | Background | Chen L, Chen Y, Chen X, Shen X, Wang Q, Sun C. Longitudinal Study of Effectiveness of a Patient-Centered Self-Management Empowerment Intervention During Predischarge Planning on Stroke Survivors. Worldviews Evid Based Nurs. 2018 Jun;15(3):197-205. doi: 10.1111/wvn.12295. |
| 21493910 | Background | Cadilhac DA, Hoffmann S, Kilkenny M, Lindley R, Lalor E, Osborne RH, Batterbsy M. A phase II multicentered, single-blind, randomized, controlled trial of the stroke self-management program. Stroke. 2011 Jun;42(6):1673-9. doi: 10.1161/STROKEAHA.110.601997. Epub 2011 Apr 14. |
| 27077987 | Background | Wolf TJ, Baum CM, Lee D, Hammel J. The Development of the Improving Participation after Stroke Self-Management Program (IPASS): An Exploratory Randomized Clinical Study. Top Stroke Rehabil. 2016 Aug;23(4):284-92. doi: 10.1080/10749357.2016.1155278. Epub 2016 Mar 16. |
| 28956721 | Background | Lee D, Fischer H, Zera S, Robertson R, Hammel J. Examining a participation-focused stroke self-management intervention in a day rehabilitation setting: a quasi-experimental pilot study. Top Stroke Rehabil. 2017 Dec;24(8):601-607. doi: 10.1080/10749357.2017.1375222. Epub 2017 Sep 28. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |