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

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:

  1. serious cognitive impairment as indicated by a score of 10 or more on the Short Blessed Test,
  2. severe depression as measured by the PHQ-2
  3. 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:
  • OPC
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

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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