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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04908085
• Other study ID #: 6032454
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: April 2024
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Quality of Life
• Sclerosis

Intervention

Behavioral:
• Occupational Performance Coaching
Six sessions of OPC delivered by telephone over 10 weeks.

Locations

Country	Name	City	State
Canada	Queen's University	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Dorothy Kessler

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Canadian Occupational Performance Measure	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	Illness Intrusiveness Rating Scale	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
Secondary	MS Impact Scale-29	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
Secondary	Connor-Davidson Resilience Scale-10	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
Secondary	Impact on Participation and Autonomy Questionnaire	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