Improving Participation After Stroke Self-Management-Rehabilitation

Официальное название

Efficacy of the Improving Participation After Stroke Self-Management-Rehabilitation (IPASS-R) Program in Sub-acute Stroke

Обзор

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.

Вмешательства

• Поведенческое Improving Participation after Stroke Self-Management Program (IPASS)
  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) in
• Поведенческое Chronic Disease Self-Management Program (CDSMP)
  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.

Первичные конечные точки

• Canadian Occupational Performance Measure (COPM) Performance [Срок оценки: Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)]
• Canadian Occupational Performance Measure (COPM) Satisfaction [Срок оценки: Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)]
• Participation Strategies Self-Efficacy Scale (PS-SES) [Срок оценки: Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)]

Вторичные конечные точки (4)

• In home activity level as measured by sensor system [Срок оценки: Duration of study (from baseline assessment (week 0) to 6-month follow-up assessment)]
• Community engagement as measured by sensor system [Срок оценки: Duration of study (from baseline assessment (week 0) to 6-month follow-up assessment)]
• Stroke Impact Scale participation domain [Срок оценки: Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)]
• Assessment of Life Habits (LIFE-H) [Срок оценки: Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)]

Критерии участия

Критерии включения

• less than 6 months post-stroke
• age 45-85 years
• completed inpatient rehabilitation services (if recommended)
• living in the community with or without caregiver support (i.e., not living in a skilled nursing facility)
• ability to read, write, and speak English
• diagnosis of mild or moderate stroke (National Institutes of Health stroke score <16)
• able to use videoconferencing independently or with caregiver support

Критерии исключения

• severe depressive symptoms as indicated by a score ≥21 on the Patient Health Questionnaire
• dementia symptoms as indicated by a score of <23 on the Montreal Cognitive Assessment
• additional neurological diagnoses (e.g., brain malignancy, previous severe stroke)
• (4) moderate or severe aphasia as indicated by a National Institutes of Health Stroke Scale aphasia score of ≥ 2
• inability to provide informed consent
• any other condition not otherwise specified that the PI determines would render participation in this study as unsafe for the participant

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Missouri — Columbia

Публикации

• 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. PMID 15733048
• 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. PMID 27469998
• 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. PMID 27545611
• 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. PMID 29878691
• 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. PMID 21493910
• 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. PMID 27077987
• 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. PMID 28956721

Идентификаторы

NCT: NCT06588647 · 2108606 · 1R01HD114732-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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