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OpenTrials
Completed

NCT Number: NCT04908085

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen's University

Kingston, Ontario, K7L 3N6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Occupational Performance coaching

Behavioral

Six sessions of OPC delivered by telephone over 10 weeks.

Other names: OPC

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Dorothy Kessler

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 1, 2021
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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