StrokeNCT01800461
Occupational Performance Coaching for Stroke Survivors
A study testing OPC-Stroke in people with Stroke, run by Ottawa Hospital Research Institute at 2 sites in Canada.
Trial summary
Participation in valued activities following stroke is a recognized problem. Efficient and effective interventions to address this problem have not yet been established although the literature provides direction as to the needs of stroke survivors and important parts of interventions to address these needs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- OPC-Stroke
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesCanada
- Study dates
- Feb 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- first hospitalization with a diagnosis of stroke (previous experience of adjustment to stroke may influence outcomes),
- discharge from acute care hospital, inpatient rehabilitation or outpatient occupational therapy to a non-institutionalized setting,
- FIM scores at rehabilitation discharge of at least 3 for expression, comprehension, memory and problem-solving (to ensure potential participants' ability to participate in coaching process) and
- live within the City of Ottawa.
Who cannot join
- Those discharged from acute or inpatient rehabilitation and are referred to outpatient stroke rehabilitation for occupational therapy will be excluded until they complete their outpatient occupational therapy (due to potential overlap of client goals while in outpatient occupational therapy)
- have other degenerative neurological diagnoses (such as Parkinson's, Multiple Sclerosis) or
- have a current major depressive or psychotic disorder.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Bruyere Continuing Care
Ottawa, Ontario, K1N 5C8
About this study
Official title: Occupational Performance Coaching for Stroke Survivors: A Novel Patient-centered Intervention to Improve Participation in Personally Valued Activities
Participation in valued activities following stroke is a recognized problem. Efficient and effective interventions to address this problem have not yet been established although the literature provides direction as to the needs of stroke survivors and important parts of interventions to address these needs. Occupational Performance Coaching (OPC) is an emerging approach to enabling occupational performance or participation in valued activities that includes these important parts of interventions. The primary goal of OPC is ability and satisfaction with participation in chosen activities, while promoting a client's ability to address future problems with participation. OPC has been successfully used with parents and their children in addressing problems with participation.
OPC has not been explored among adults who have experienced a stroke. For this study OPC-Stroke (OPC adapted for stroke survivors) will be tested to explore its potential effectiveness for increasing participation as well as how feasible and acceptable the research methods are. Sixteen participants who receive OPC-Stroke will be compared with sixteen who do not using measures of participation, goal achievement, well-being, self-efficacy and cognition. Those who receive OPC-Stroke will also be interviewed about their experience of the treatment.
Read the detailed description
Introduction Approximately 300,000 Canadians live with the effects of stroke. Following hospital discharge, stroke survivors attempt to return to participation in valued activities but this can be quite challenging. In fact, the majority of stroke survivors, across all disability levels, report problems occupying their time in meaningful ways.
Current interventions to enhance participation in valued activities have been limited and studies of these have had mixed results. This may be due to lack on consideration of important factors. As well, it is possible that success has been limited because there is not yet an efficient way to provide the kind of long term, individualized support that is required for successful return to valued activities. Effective and efficient interventions must be designed to build competence and provide stroke survivors with the skills and the tools they need to allow them to plan and manage their own return to personally valued activities over several months of recovery.
Occupational Performance Coaching (OPC) is a new approach in occupational therapy whereby individuals are guided to solve problems critical to the achievement of self-identified goals related to participation. OPC draws on concepts from personal coaching, solution-focused therapy, problem solving interventions and emotional support. A positive, strengths-based approach is used to promote patient self-efficacy and self-management. This individualized approach provides a time-limited intervention to address current participation goals, while allowing individuals to develop the skills to address future participation goals. OPC has been tested with families of children who face challenges participating in age appropriate activities but has not been tested with adults who have experienced stroke. Following review of the literature, an adaptation of OPC for stroke survivors (OPC-Stroke) was developed that emphasizes individualized education and metacognitive strategies during both goal setting and problem solving, and broadens how support is considered beyond the family.
The purpose of this research is to explore the effectiveness of OPC-Stroke with adults who have experienced stroke and to examine the feasibility and acceptability of the research methods in preparation for a larger randomized controlled trial (RCT). This objective will be attained through answering the following questions:
- Do stroke survivors receiving OPC-Stroke following discharge to the community report increased participation compared with those receiving standard care.
- Do stroke survivors receiving OPC-Stroke following discharge to the community report increased performance and satisfaction with individually identified participation goals, emotional wellbeing, goal self-efficacy, cognition and mobility compared with those receiving standard care?
- What is the experience of research participants receiving OPC-Stroke?
- Which components and processes of OPC-Stroke promote achievement of self-identified participation goals?
- Are the research procedures feasible to implement and are they acceptable to participants and therefore appropriate for testing OPC-Stroke in a larger trial.
Design This study will use a concurrent mixed method design of a pilot RCT with an embedded qualitative study. The qualitative component of this study will be a descriptive qualitative study with the goal of exploring the experience of participants who receive OPC-Stroke and providing insight into the components and processes of OPC-Stroke that promote goal achievement.
Study Population Thirty-two stroke survivors being discharged home from the acute stroke unit at The Ottawa Hospital or the Bruyère in-patient stroke rehabilitation unit will be recruited to the study.
Participants will be recruited at the time of discharge from hospital. The occupational therapists at the hospitals will screen potential participants and refer potentially interested patients to the Research Assistant who will seek informed consent.
Randomization Following consent to participate in the research study and completion of the initial outcome measures, participants will be allocated to the treatment or control group using block randomization (block size of 4). The randomization and allocation process will be completed by the statistician on contract with Bruyère Research Institute to ensure that randomization is adequate and group allocation cannot be tampered with.
The OPC-Stroke intervention consists of 10 face to face visits with an occupational therapist trained in OPC over a 16 week period. Visits will last approximately one hour.
Since the one of the secondary outcomes is changes in performance and satisfaction with individually-identified participation goals, all participants will receive the first visit prior to randomization. During this visit the coach will use the Personal Project Analysis tool combined with the Canadian Occupational Performance Measure (COPM) to facilitate discussion of and reflection on current participation in activities/projects. Three personal projects will be identified by each participant as intervention goals, and OPC-Stroke sessions will be focused on these projects. Finally, during this first session each participants will score their current performance and satisfaction in these projects using the COPM; as well as goal self-efficacy for each goal
Intervention participants will proceed directly to receive the OPC-Stroke intervention. As noted in the introduction, OPC-Stroke is a process of goal-focussed problem solving and collaborative performance analysis examining the interaction between the person, the environment and the task demands of the project/goal. Throughout the process, the coach will provide emotional support and promote exchange of information. During the final intervention visit, goal progress and the problem solving process will be reviewed.
Control Group The purpose of the control group in this study is to enhance internal validity including controlling for change that may occur with the passage of time. This is particularly relevant following stroke as the course of natural recovery and adjustment may lead to changes in participation. Therefore a usual care option for the control group was selected. Usual care is may consist of limited outpatient therapy (excluding occupational therapy) and/or personal support services for activities of daily living.
- Conditions
- Stroke
- Being tested
- OPC-Stroke, Usual care
- Keywords
- Participation, Occupational Therapy, Valued Activities
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPC-StrokeOther
Occupational therapy coaching intervention
Usual careOther
Usual community care
| Study group | Role | What they receive |
|---|---|---|
| OPC-Stroke, Usual care | Experimental | OPC-Stroke - 10 weekly sessions of goal setting followed by problem solving process Receives: Other: OPC-Stroke; Other: Usual care |
| Usual care | Other | Usual care - Follow-up by physician and possible receipt of home care services Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Reintegration to Normal Living Index score
Measurement of change in level of participation from baseline to immediately post-intervention(average of 14 weeks) and to 6 months.
Measured: Baseline, average of 14 weeks, and 6 months
Secondary outcomes (4)
Change in Canadian Occupational Performance Measure scores
Measured: Baseline, average of 14 weeks, and 6 months
Change in Hospital Anxiety and Depression Scale score
Measure of change in overall well-being
Measured: Baseline, average of 14 weeks, and 6 months
Change in Goals Systems Assessment Battery - Directive Functions Indicators score
Measure of change in goal self-efficacy
Measured: Baseline, average of 14 weeks, and 6 months
Change in Montreal Cognitive Assessment score
Measure of change in cognition
Measured: Baseline, average of 14 weeks, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ottawa
- Responsible party
- Principal investigator, Dorothy Kessler, Ottawa Hospital Research Institute
- Investigators
- Dorothy Kessler, M. Sc., Principal investigator, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800461
- Sponsor's protocol ID
- 20120844-01H
- Status last verified
- Oct 2015
- First submitted
- 22 Feb 2013
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kessler D, Egan M, Dubouloz CJ, McEwen S, Graham FP. Occupational Performance Coaching for Stroke Survivors: A Pilot Randomized Controlled Trial. Am J Occup Ther. 2017 May/Jun;71(3):7103190020p1-7103190020p7. doi: 10.5014/ajot.2017.024216.
PubMed 28422628Kessler DE, Egan MY, Dubouloz CJ, Graham FP, McEwen SE. Occupational performance coaching for stroke survivors: a pilot randomized controlled trial protocol. Can J Occup Ther. 2014 Dec;81(5):279-88. doi: 10.1177/0008417414545869.
PubMed 25702372
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational Performance Coaching for Stroke Survivors: A Novel Patient-centered Intervention to Improve Participation in Personally Valued Activities
- ClinicalTrials.gov ID
- NCT01800461
- Acronym / sponsor ID
- 20120844-01H
- Conditions
- Stroke
- Keywords
- Participation, Occupational Therapy, Valued Activities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- University of Ottawa
- Study start
- Feb 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 27 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participation in valued activities following stroke is a recognized problem. Efficient and effective interventions to address this problem have not yet been established although the literature provides direction as to the needs of stroke survivors and important parts of interventions to address these needs. Occupational Performance Coaching (OPC) is an emerging approach to enabling occupational performance or participation in valued activities that includes these important parts of interventions. The primary goal of OPC is ability and satisfaction with participation in chosen activities, while promoting a client's ability to address future problems with participation. OPC has been successfully used with parents and their children in addressing problems with participation.
OPC has not been explored among adults who have experienced a stroke. For this study OPC-Stroke (OPC adapted for stroke survivors) will be tested to explore its potential effectiveness for increasing participation as well as how feasible and acceptable the research methods are. Sixteen participants who receive OPC-Stroke will be compared with sixteen who do not using measures of participation, goal achievement, well-being, self-efficacy and cognition. Those who receive OPC-Stroke will also be interviewed about their experience of the treatment.
Detailed description
Introduction Approximately 300,000 Canadians live with the effects of stroke. Following hospital discharge, stroke survivors attempt to return to participation in valued activities but this can be quite challenging. In fact, the majority of stroke survivors, across all disability levels, report problems occupying their time in meaningful ways.
Current interventions to enhance participation in valued activities have been limited and studies of these have had mixed results. This may be due to lack on consideration of important factors. As well, it is possible that success has been limited because there is not yet an efficient way to provide the kind of long term, individualized support that is required for successful return to valued activities. Effective and efficient interventions must be designed to build competence and provide stroke survivors with the skills and the tools they need to allow them to plan and manage their own return to personally valued activities over several months of recovery.
Occupational Performance Coaching (OPC) is a new approach in occupational therapy whereby individuals are guided to solve problems critical to the achievement of self-identified goals related to participation. OPC draws on concepts from personal coaching, solution-focused therapy, problem solving interventions and emotional support. A positive, strengths-based approach is used to promote patient self-efficacy and self-management. This individualized approach provides a time-limited intervention to address current participation goals, while allowing individuals to develop the skills to address future participation goals. OPC has been tested with families of children who face challenges participating in age appropriate activities but has not been tested with adults who have experienced stroke. Following review of the literature, an adaptation of OPC for stroke survivors (OPC-Stroke) was developed that emphasizes individualized education and metacognitive strategies during both goal setting and problem solving, and broadens how support is considered beyond the family.
The purpose of this research is to explore the effectiveness of OPC-Stroke with adults who have experienced stroke and to examine the feasibility and acceptability of the research methods in preparation for a larger randomized controlled trial (RCT). This objective will be attained through answering the following questions:
- Do stroke survivors receiving OPC-Stroke following discharge to the community report increased participation compared with those receiving standard care.
- Do stroke survivors receiving OPC-Stroke following discharge to the community report increased performance and satisfaction with individually identified participation goals, emotional wellbeing, goal self-efficacy, cognition and mobility compared with those receiving standard care?
- What is the experience of research participants receiving OPC-Stroke?
- Which components and processes of OPC-Stroke promote achievement of self-identified participation goals?
- Are the research procedures feasible to implement and are they acceptable to participants and therefore appropriate for testing OPC-Stroke in a larger trial.
Design This study will use a concurrent mixed method design of a pilot RCT with an embedded qualitative study. The qualitative component of this study will be a descriptive qualitative study with the goal of exploring the experience of participants who receive OPC-Stroke and providing insight into the components and processes of OPC-Stroke that promote goal achievement.
Study Population Thirty-two stroke survivors being discharged home from the acute stroke unit at The Ottawa Hospital or the Bruyère in-patient stroke rehabilitation unit will be recruited to the study.
Participants will be recruited at the time of discharge from hospital. The occupational therapists at the hospitals will screen potential participants and refer potentially interested patients to the Research Assistant who will seek informed consent.
Randomization Following consent to participate in the research study and completion of the initial outcome measures, participants will be allocated to the treatment or control group using block randomization (block size of 4). The randomization and allocation process will be completed by the statistician on contract with Bruyère Research Institute to ensure that randomization is adequate and group allocation cannot be tampered with.
The OPC-Stroke intervention consists of 10 face to face visits with an occupational therapist trained in OPC over a 16 week period. Visits will last approximately one hour.
Since the one of the secondary outcomes is changes in performance and satisfaction with individually-identified participation goals, all participants will receive the first visit prior to randomization. During this visit the coach will use the Personal Project Analysis tool combined with the Canadian Occupational Performance Measure (COPM) to facilitate discussion of and reflection on current participation in activities/projects. Three personal projects will be identified by each participant as intervention goals, and OPC-Stroke sessions will be focused on these projects. Finally, during this first session each participants will score their current performance and satisfaction in these projects using the COPM; as well as goal self-efficacy for each goal
Intervention participants will proceed directly to receive the OPC-Stroke intervention. As noted in the introduction, OPC-Stroke is a process of goal-focussed problem solving and collaborative performance analysis examining the interaction between the person, the environment and the task demands of the project/goal. Throughout the process, the coach will provide emotional support and promote exchange of information. During the final intervention visit, goal progress and the problem solving process will be reviewed.
Control Group The purpose of the control group in this study is to enhance internal validity including controlling for change that may occur with the passage of time. This is particularly relevant following stroke as the course of natural recovery and adjustment may lead to changes in participation. Therefore a usual care option for the control group was selected. Usual care is may consist of limited outpatient therapy (excluding occupational therapy) and/or personal support services for activities of daily living.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPC-Stroke, Usual care | Experimental | Other: OPC-Stroke, Other: Usual careOPC-Stroke - 10 weekly sessions of goal setting followed by problem solving process |
| Usual care | Other | Other: Usual careUsual care - Follow-up by physician and possible receipt of home care services |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- first hospitalization with a diagnosis of stroke (previous experience of adjustment to stroke may influence outcomes),
- discharge from acute care hospital, inpatient rehabilitation or outpatient occupational therapy to a non-institutionalized setting,
- FIM scores at rehabilitation discharge of at least 3 for expression, comprehension, memory and problem-solving (to ensure potential participants' ability to participate in coaching process) and
- live within the City of Ottawa.
Key exclusion criteria (3 listed)
- Those discharged from acute or inpatient rehabilitation and are referred to outpatient stroke rehabilitation for occupational therapy will be excluded until they complete their outpatient occupational therapy (due to potential overlap of client goals while in outpatient occupational therapy)
- have other degenerative neurological diagnoses (such as Parkinson's, Multiple Sclerosis) or
- have a current major depressive or psychotic disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPC-StrokeOccupational therapy coaching intervention | Other | OPC-Stroke, Usual care |
| Usual careUsual community care | Other | OPC-Stroke, Usual care, Usual care |
Primary outcome
Change in Reintegration to Normal Living Index score
Time frame: Baseline, average of 14 weeks, and 6 months
Measurement of change in level of participation from baseline to immediately post-intervention(average of 14 weeks) and to 6 months.
4 secondary outcomes
Change in Canadian Occupational Performance Measure scores
Time frame: Baseline, average of 14 weeks, and 6 months
Change in Hospital Anxiety and Depression Scale score
Time frame: Baseline, average of 14 weeks, and 6 months
Change in Goals Systems Assessment Battery - Directive Functions Indicators score
Time frame: Baseline, average of 14 weeks, and 6 months
Change in Montreal Cognitive Assessment score
Time frame: Baseline, average of 14 weeks, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2015.
- Derived from this study: PubMed 28422628Kessler D, Egan M, Dubouloz CJ, McEwen S, Graham FP. Occupational Performance Coaching for Stroke Survivors: A Pilot Randomized Controlled Trial. Am J Occup Ther. 2017 May/Jun;71(3):7103190020p1-7103190020p7. doi: 10.5014/ajot.2017.024216.
- Derived from this study: PubMed 25702372Kessler DE, Egan MY, Dubouloz CJ, Graham FP, McEwen SE. Occupational performance coaching for stroke survivors: a pilot randomized controlled trial protocol. Can J Occup Ther. 2014 Dec;81(5):279-88. doi: 10.1177/0008417414545869.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dorothy Kessler, M. Sc. principal investigator
University of Ottawa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPC-Stroke in people with Stroke, run by Ottawa Hospital Research Institute at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Reintegration to Normal Living Index score (time frame: Baseline, average of 14 weeks, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01800461, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2015.