Creating Satisfying Engagement in Daily Life Through Coaching for People With Multiple Sclerosis

Sponsor
Queen's University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04908085
Collaborator
(none)
31
1
2
9
3.5

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Occupational Performance Coaching
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Waitlist control trialWaitlist control trial
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Creating Satisfying Engagement in Daily Life Through Coaching for People With Multiple
Actual Study Start Date :
Oct 1, 2021
Actual Primary Completion Date :
Jan 15, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: OPC

Occupational Performance Coaching delivered by telephone

Behavioral: Occupational Performance Coaching
Six sessions of OPC delivered by telephone over 10 weeks.
Other Names:
  • OPC
  • No Intervention: Waitlist control

    Intervention provided after post intervention assessment

    Outcome Measures

    Primary Outcome Measures

    1. Change in Canadian Occupational Performance Measure [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.

    Secondary Outcome Measures

    1. Illness Intrusiveness Rating Scale [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.

    2. MS Impact Scale-29 [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.

    3. Connor-Davidson Resilience Scale-10 [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.

    4. Impact on Participation and Autonomy Questionnaire [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Queen's University Kingston Ontario Canada K7L 3N6

    Sponsors and Collaborators

    • Queen's University

    Investigators

    • Principal Investigator: Dorothy Kessler, Queen's University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dorothy Kessler, Assistant Professor, Queen's University
    ClinicalTrials.gov Identifier:
    NCT04908085
    Other Study ID Numbers:
    • 6032454
    First Posted:
    Jun 1, 2021
    Last Update Posted:
    May 4, 2022
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dorothy Kessler, Assistant Professor, Queen's University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 4, 2022