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NCT Number: NCT07759791

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Providence care Hospital, Kingston, Ontario, Canada

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About this study

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.

The proposed study will establish the efficacy of OPC for improving participation in valued activities (Canadian Occupational Performance Measure), self-efficacy (Participation Strategeis Self-Efficacy Scale), physical activity (AcivPal activity monitor), cognition (CogniFit computerized assessments : a)Trail Making Test measures processing speed, shifting and visual attention; b) the Stroop test measures inhibition, updating, visual perception, naming, processing speed and response time; and c) the Visual Working Memory Span Test measures spatial perception, short-term memory, visual short-term memory, non-verbal memory, working memory, planning, processing speed, and response time), and emotional well-being (Generalized Anxiety Disorders Scale-7 and Brief Patient Health Questionnaire ). In addition, wthe investigators will conduct a process evaluation to examine characteristics of participants that act as mediators or moderators to improve participation in valued activity goals and to explore how OPC works with different subgroups of stroke participants (e.g., stroke severity, age, sex, and gender).

The investigators will conduct a double-blind randomized controlled trial to test whether OPC delivered virtually enhances participation in valued activities among people with stroke compared to an active control condition.

The investigators will recruit 118 patients from inpatient stroke rehabilitation and randomly assign them (stratified by stroke severity) to OPC (intervention group) or computerized cognitive therapy with check-ins (active control group) at the end of publicly funded rehabilitation. Participants will be 3 to 12 months post-stroke. A blinded research assistant will administer outcomes at baseline, post-intervention, and at 3-month follow-up. The primary outcome will be participation in valued activities. Secondary outcomes will be participation self-efficacy, physical activity, cognition, and emotional well-being. The investigators will examine mediators and moderators that impact the outcome of OPC and interview a subsample of 20 participants who receive OPC to better understand how OPC works with people of different stroke severity, age, sex, and gender.

Participants, blinded to study purposes, will receive 10 one-hour sessions of either OPC or an active control delivered virtually using Zoom over 15 weeks.

Between-group differences across the three timepoints for each outcome will be tested using repeated measures ANOVA. Interview transcripts will be analyzed using content analysis.

This project addresses an important knowledge gap related to improving participation among patients with stroke. The investigators will establish the efficacy of OPC, an established adaptive intervention, and expand our understanding of how it works. Without evidence-based interventions to promote participation, stroke survivors will continue to struggle to return to valued activities and miss out on associated health benefits (physical, cognitive, emotional). This work will also build on evidence for virtual approaches to stroke rehabilitation; these approaches have the potential to improve accessibility to rehabilitation for stroke survivors.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Occupational Performance Coaching (OPC)

Behavioral

Occupational Performance Coaching (OPC) is an innovative, person-centered, strengths-based intervention designed to enhance participation in valued activities after stroke. OPC targets modifiable factors such as goal setting, self-efficacy, emotional support, problem-solving, and individualized education. Through a collaborative process, therapists partner with stroke survivors to identify challenges, set meaningful goals, and experiment with tailored solutions, refining them until successful strategies are found. Research shows OPC is feasible, acceptable, and effective, with participants demonstrating significant improvements in performance, satisfaction, and re-engagement in valued activities within 8-10 sessions, both in-person and via telerehabilitation. By fostering physical, cognitive, and emotional well-being, OPC addresses barriers like social isolation, physical inactivity, and low self-efficacy. Delivered virtually, OPC overcomes challenges in accessing rehabilitation, parti

computer cognitive training program (CogniFit)

Device

Active control (AC) group will receive access to the CogniFit computer-based cognitive training program, a personalized brain training tool designed to target perception, attention, memory, and reasoning.While cognitive training can improve global cognition, working memory, attention, and executive function, it has not shown effects on daily activities or depression.

Primary outcomes

  1. 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

  1. Participation Strategies Self-Efficacy Scale (PS-SES)

    Time frame: Baseline, periprocedural, and 3-months after periprocedural assessment

    The Participation Strategies Self-Efficacy Scale (PS-SES) is a 35-item scale that measures self-efficacy in using strategies for participation in home, community, work, and social activities. Each item is scored on a scale of 1 (not at all confident) to 10 (totally confident) total score ranges from 35 to 350 with higher scores indicating higher self-efficacy.

  2. Time spent in active veruss sedentary activity

    Time frame: Baseline, periprocedural, and 3-months after periprocedural assessment

    Time spent in active (i.e., standing, walking) versus sedentary (i.e., sitting, lying) activites willk be measured using the ActivPal 4 activity monitor (PAL Technologies Ltd., Glasgow, UK). The ActivPal is a small, lightweight wearable device that measures movement with a triaxial accelerometer and body posture with a gyroscope. Consistent with recommendations for obtaining a good representation of typical physical activity, it will be worn for seven consecutive days ateach data colleciton timepoint. An average of active versus sedentary time will be calculated.

  3. Generalized Anxiety Disorders Scale-7 (GAD-7)

    Time frame: Baseline, periprocedural, and 3-months after periprocedural assessment

    The Generalized Anxiety Disorders Scale-7 (GAD-7) is a brief 7-item screening tool for anxiety that captures the frequency of anxiety-related symptoms. The GAD-7 is a valid, reliable, and responsive measure commonly used in stroke rehabilitation research. Items are socred on a scale of 0 (not at all) to 3 (nearly everyday). Total score ranges from 0-21 with higher scores indicating higher anxiety.

  4. Executive Functioning

    Time frame: Baseline, periprocedural, and 3-months after periprocedural assessment

    Executive functioning will be measured using the following CogniFit computerized assessments : a) the Trail Making Test (TMT) measures processing speed, shifting and visual attention; b) the Stroop test measures inhibition, updating, visual perception, naming, processing speed and response time; and c) the Visual Working Memory Span Test measures spatial perception, short-term memory, visual short-term memory, non-verbal memory, working memory, planning, processing speed, and response time. These tests have demonstrated reliability and validity with older adults.

    Overall executive functioning will be represented using Z scores.

  5. Brief Patient Health Questionnaire (PhQ-9)

    Time frame: Baseline, periprocedural, and 3-months after periprocedural assessment

    The Brief Patient Health Questionnaire (PHQ-9) is a brief 9-item screening tool for depression. PhQ-9 is a valid, reliable, and responsive measure commonly used in stroke rehabilitation research. Items are scored on a scale of 0 (not at all) to 3 (nearly every day). Total score ranges form 0 to 27 with higher scores indicating higher depression.

Study contacts

Contact information is provided by the study sponsor or research team.

Dorothy Kessler, PhD

CONTACT

[email protected]

613-533-6551

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Collaborators

  • Bruyère Health Research Institute.
  • Providence Care Hospital

Registry information

Acronym: No acronyms

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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