跳至主要内容
临床试验/NCT07759791
NCT07759791招募中不适用

Supporting Re-engagement in Life: Coaching to Enhance Participation in Valued Activities Following Stroke

Queen's University2 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2025年11月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
118
试验地点
2
主要终点
Canadian Occupational Performance Measure (COPM)

研究概览

简要总结

The goal of this clinical trial is to determine whether Occupational Performance Coaching (OPC), a person-centered, strength-based intervention, can improve participation in valued activities among adults who have experienced a stroke and recently completed community- or clinic-based stroke rehabilitation.

The main questions it aims to answer are:

Does OPC improve performance and satisfaction with participation in personally valued activities?

Does OPC improve participation self-efficacy, physical activity, cognition, and emotional well-being compared to an active attention control intervention?

Researchers will compare the OPC group to an active attention control group to see if OPC leads to greater improvements in participation and secondary outcomes.

Participants will:

Be randomized to receive either OPC (delivered virtually, including collaborative goal-setting and problem-solving) or an active attention control intervention.

Complete assessments of participation in valued activties, physical activity (using movement sensors), self-efficacy, cognition, and mood immediately after treatment and at 3 months.

A subset of 20 participants from intervention group will take part in interviews to share their experiences.

详细描述

Most stroke survivors, access of all levels of impairment, have difficulty returning to valued activities and social roles, leading to loss of sense of self and purpose in life and impacting both physical and mental health. Occupational Performance Coaching (OPC) shows promise in quickly returning people to their valued activities, thereby offering hope and improving well-being. This project asks, "Will OPC, an innovative adaptive approach to returning people quickly to their valued activities, lead to increased participation for individuals with stroke?"

The experience of stroke is devastating for both stroke survivors and their families. The process of picking up the pieces, adjusting, and finding ways to engage in activities that provide meaning and purpose is complex, requiring emotional and practical support, access to information, and opportunities to test abilities and try new ways of doing. With much of the focus of rehabilitation practice and guidelines being on reducing impairment, it is not surprising that stroke survivors feel lost and ill-prepared to participate in their valued activities when formal rehabilitation ends. Effective adaptive interventions are needed to return people quickly to activities to prevent negative outcomes associated with decreased participation.

OPC is a person-centred, strengths-based, adaptive approach that focuses on providing emotional support, collaborative goal setting, solution-focused problem-solving, and experimentation to build knowledge, skills, and self-efficacy for participation. OPC capitalizes on modifiable factors influencing participation after stroke. and builds the skills needed for stroke survivors to continue setting and achieving goals on their own.

OPC is the most widely researched coaching intervention in occupational therapy and stroke rehabilitation. PI Kessler the lead international researcher testing OPC with adults with neurological conditions, namely stroke and multiple sclerosis. Pilot feasibility studies demonstrated the potential of OPC, delivered in person or virtually, to return individuals living with stroke to valued activities within 8-10 sessions.

Based on previous participation research, through enhancing participation in personally valued activities, OPC may enhance self-efficacy, physical activity, cognitive abilities, and emotional well-being.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Be living in the community (home, retirement home)
  • •Have completed publicly funded rehabilitation
  • •Are 3 to 12 months post-first stroke.
  • •Be able to communicate in English
  • •Have adequate comprehension and memory to participate in the coaching process. (Must have FIM scores of at least 3 (needs assistance less than 50% of the time) for comprehension and memory at the time of discharge from inpatient rehabilitation).

排除标准

  • •We will exclude individuals with unstable major psychiatric conditions or neurodegenerative conditions.

研究组 & 干预措施

OPC Intervention Group (occupational performance couching groups

Experimental

Participants will receive 10 one-hour telerehabilitation sessions delivered via Zoom (Zoom Video Communications Inc., San Jose, CA) over a 15-week period. Sessions will be delivered by an Occupational Therapist trained in the Occupational Performance Coaching (OPC) approach and in telerehabilitation service delivery. The 15-week period allows flexibility for scheduling (e.g., to accommodate appointments or vacations).

干预措施: Occupational Performance Coaching (OPC) (Behavioral)

Active Control (AC) Group

Active Comparator

Participants will receive access to the CogniFit (computer cognitive training program (CogniFit Inc. © 2024) for 15 weeks. There will be 10 virtual contacts via Zoom. The AC interventionist will be trained in telerehabilitation service delivery. The program is designed to train perception, attention, memory, and reasoning.

干预措施: computer cognitive training program (CogniFit) (Device)

结局指标

主要结局

Canadian Occupational Performance Measure (COPM)

时间窗: Baseline, periprocedural, and 3-months after periprocedural assessment

The Canadian Occupational Performance Measure (COPM) is a reliable, valid, and responsive tool frequently used in stroke rehabilitation outcome studies. Using the COPM, participants identify problems related to participation in valued activities that are then rated by participants for performance and satisfaction with current status on a scale of 1-10, where 10 indicates optimal performance or satisfaction. Numbers are summed and divided by the number of goals.

次要结局

  • Participation Strategies Self-Efficacy Scale (PS-SES)(Baseline, periprocedural, and 3-months after periprocedural assessment)
  • Time spent in active veruss sedentary activity(Baseline, periprocedural, and 3-months after periprocedural assessment)
  • Generalized Anxiety Disorders Scale-7 (GAD-7)(Baseline, periprocedural, and 3-months after periprocedural assessment)
  • Executive Functioning(Baseline, periprocedural, and 3-months after periprocedural assessment)
  • Brief Patient Health Questionnaire (PhQ-9)(Baseline, periprocedural, and 3-months after periprocedural assessment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dorothy Kessler

Dr.

Queen's University

研究点 (2)

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