- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04908085
Creating Satisfying Engagement in Daily Life Through Coaching for People With Multiple Sclerosis
April 17, 2024 updated by: Dorothy Kessler
Creating Satisfying Engagement in Daily Life Through Coaching for People With Multiple
Multiple sclerosis (MS) is a complex disease that negatively impacts a person's ability to participate in a wide range of important and meaningful activities1-4.
MS rehabilitation interventions often focus on reducing symptoms, with the assumption that fewer symptoms will lead to improved participation in daily activities5-8.
Yet, literature shows that engagement in necessary and desired activities requires more than symptom reduction - it requires people with chronic diseases like MS to apply their knowledge and skills to a complex self-management process9-11 that balances personal values, and activity and environmental demands.
Core self-management skills include self-monitoring, problem-solving, decision-making, goal setting, action planning, and the ability to adjust plans when necessary12.
Looking beyond MS, coaching interventions have enabled people with stroke13-16, traumatic brain injury17, and Parkinson's disease18, 19 to develop self-management skills and achieve personally meaningful activity goals.
Occupational Performance Coaching (OPC) is a well-developed form of coaching that builds competence in core self-management skills and improves participation in daily activities20, 21.
The investigator's preliminary work indicates that OPC is an acceptable and feasible intervention for people with MS22.
The investigators now must determine if OPC reduces the impact of MS on participation in daily activities and increases the satisfaction of people with MS in performance of personally important daily activities.
Therefore, the investigators will conduct a waitlist-control randomized clinical trial (RCT) with 30 adults with MS to determine if receipt of six OPC sessions improves participants' satisfaction with performance in daily activities (primary outcome).
The investigators will also examine whether OPC reduces illness intrusiveness (MS impact), improves resilience, and improves autonomy and participation (secondary outcomes).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Kingston, Ontario, Canada, K7L 3N6
- Queen's University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- able to participate in coaching in English.
Exclusion Criteria:
- serious cognitive impairment as indicated by a score of 10 or more on the Short Blessed Test,
- severe depression as measured by the PHQ-2
- are receiving life, health or executive coaching by a certified coach
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: OPC
Occupational Performance Coaching delivered by telephone
|
Six sessions of OPC delivered by telephone over 10 weeks.
Other Names:
|
|
No Intervention: Waitlist control
Intervention provided after post intervention assessment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Canadian Occupational Performance Measure
Time Frame: Pre-intervention, 10 weeks, and 2 months post intervention
|
Measure of performance and satisfaction with performance and satisfaction on a scale of 1-10 where 10 indicates higher performance or satisfaction with performance.
|
Pre-intervention, 10 weeks, and 2 months post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Illness Intrusiveness Rating Scale
Time Frame: Pre-intervention, 10 weeks, and 2 months post intervention
|
The Illness Intrusiveness Rating Scale captures induced interference of chronic disease and treatment on valued activities and interests.
The scale is a brief self-report questionnaire that is composed of 13 items: health, diet, work, active recreation, passive recreation, financial situation, relationship with your spouse, sex life, family relations, other social relations, self-expression/ self-improvement, religious expression, and community and civic involvement.
Respondents rate the degree to which their illness and/or treatment interfere with these domains using a seven-point scale (1- not very much, 7 - very much).
A higher overall score (range13-91) indicates a higher level of illness intrusiveness.
|
Pre-intervention, 10 weeks, and 2 months post intervention
|
|
MS Impact Scale-29
Time Frame: Pre-intervention, 10 weeks, and 2 months post intervention
|
The MS Impact scale is a 29-item scale that measures the impact of MS on day-to day life on a scale from 1 (not at all) to 5 (extremely).
Higher scores (range 29-145) indicate higher impact of MS on daily life.
|
Pre-intervention, 10 weeks, and 2 months post intervention
|
|
Connor-Davidson Resilience Scale-10
Time Frame: Pre-intervention, 10 weeks, and 2 months post intervention
|
The CDRS is a 10 item questionnaire used to measure participant's perception of their ability to cope and adapt to challenges.
Scores range from 0-40 where a higher score indicates better resilience.
|
Pre-intervention, 10 weeks, and 2 months post intervention
|
|
Impact on Participation and Autonomy Questionnaire
Time Frame: Pre-intervention, 10 weeks, and 2 months post intervention
|
The IPA provides a measure of limitations in participation and autonomy.
The tool includes 39 questions across 5 domains: autonomy indoors, autonomy outdoors, family role, social life and relationships, and work and education.
Participants rate each item on scale from 0 (very good) to 4 (very poor).
Score range is 0-156 with higher scores representing poorer autonomy and participation.
|
Pre-intervention, 10 weeks, and 2 months post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dorothy Kessler, Queen's University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2021
Primary Completion (Actual)
June 30, 2022
Study Completion (Actual)
June 30, 2022
Study Registration Dates
First Submitted
May 19, 2021
First Submitted That Met QC Criteria
May 25, 2021
First Posted (Actual)
June 1, 2021
Study Record Updates
Last Update Posted (Actual)
April 19, 2024
Last Update Submitted That Met QC Criteria
April 17, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6032454
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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