Supporting Re-engagement in Life: Coaching to Enhance Participation in Valued Activities Following Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Queen's University
- Enrollment
- 118
- Locations
- 2
- Primary Endpoint
- Canadian Occupational Performance Measure (COPM)
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
Exclusion Criteria
- •We will exclude individuals with unstable major psychiatric conditions or neurodegenerative conditions.
Arms & Interventions
OPC Intervention Group (occupational performance couching groups
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).
Intervention: Occupational Performance Coaching (OPC) (Behavioral)
Active Control (AC) Group
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.
Intervention: computer cognitive training program (CogniFit) (Device)
Outcomes
Primary Outcomes
Canadian Occupational Performance Measure (COPM)
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Dorothy Kessler
Dr.
Queen's University