跳至主要内容
临床试验/NCT06588647
NCT06588647
招募中
不适用

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

University of Missouri-Columbia2 个研究点 分布在 1 个国家目标入组 100 人2024年12月16日

概览

阶段
不适用
干预措施
Improving Participation after Stroke Self-Management Program (IPASS)
疾病 / 适应症
Stroke
发起方
University of Missouri-Columbia
入组人数
100
试验地点
2
主要终点
Canadian Occupational Performance Measure (COPM) Performance
状态
招募中
最后更新
4天前

概览

简要总结

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.

注册库
clinicaltrials.gov
开始日期
2024年12月16日
结束日期
2029年12月15日
最后更新
4天前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Anna Boone

Assistant Professor of Occupational Therapy

University of Missouri-Columbia

入排标准

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Improving Participation after Stroke Self-Management Program (IPASS)

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.

干预措施: Improving Participation after Stroke Self-Management Program (IPASS)

Chronic Disease Self-Management Program (CDSMP)

The CDSMP will consist of 6, weekly 90-minute sessions. All sessions will be delivered remotely via videoconferencing.

干预措施: Chronic Disease Self-Management Program (CDSMP)

结局指标

主要结局

Canadian Occupational Performance Measure (COPM) Performance

时间窗: Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)

Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.

Canadian Occupational Performance Measure (COPM) Satisfaction

时间窗: Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)

Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean higher satisfaction.

Participation Strategies Self-Efficacy Scale (PS-SES)

时间窗: Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)

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.

次要结局

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

研究点 (2)

Loading locations...

相似试验