Stroke Clinical Trial
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.
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:
1. Do stroke survivors receiving OPC-Stroke following discharge to the community report
increased participation compared with those receiving standard care.
2. 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?
3. What is the experience of research participants receiving OPC-Stroke?
4. Which components and processes of OPC-Stroke promote achievement of self-identified
participation goals?
5. 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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
| Recruiting |
NCT03869138 -
Alternative Therapies for Improving Physical Function in Individuals With Stroke
|
N/A | |
| Completed |
NCT04034069 -
Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
|
N/A | |
| Completed |
NCT04101695 -
Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects
|
N/A | |
| Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
| Completed |
NCT00391378 -
Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
|
N/A | |
| Recruiting |
NCT06204744 -
Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial
|
N/A | |
| Active, not recruiting |
NCT06043167 -
Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
|
||
| Active, not recruiting |
NCT04535479 -
Dry Needling for Spasticity in Stroke
|
N/A | |
| Completed |
NCT03985761 -
Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke
|
N/A | |
| Recruiting |
NCT00859885 -
International PFO Consortium
|
N/A | |
| Recruiting |
NCT06034119 -
Effects of Voluntary Adjustments During Walking in Participants Post-stroke
|
N/A | |
| Completed |
NCT03622411 -
Tablet-based Aphasia Therapy in the Chronic Phase
|
N/A | |
| Completed |
NCT01662960 -
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
|
N/A | |
| Recruiting |
NCT05854485 -
Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
|
N/A | |
| Active, not recruiting |
NCT05520528 -
Impact of Group Participation on Adults With Aphasia
|
N/A | |
| Completed |
NCT03366129 -
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
|
||
| Completed |
NCT05805748 -
Serious Game Therapy in Neglect Patients
|
N/A | |
| Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
| Recruiting |
NCT05993221 -
Deconstructing Post Stroke Hemiparesis
|