NCT04908085

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 1, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

9 months

First QC Date

May 19, 2021

Last Update Submit

April 17, 2024

Conditions

Keywords

Coaching

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Illness Intrusiveness Rating Scale

    Pre-intervention, 10 weeks, and 2 months post intervention

  • MS Impact Scale-29

    Pre-intervention, 10 weeks, and 2 months post intervention

  • Connor-Davidson Resilience Scale-10

    Pre-intervention, 10 weeks, and 2 months post intervention

  • Impact on Participation and Autonomy Questionnaire

    Pre-intervention, 10 weeks, and 2 months post intervention

Study Arms (2)

OPC

EXPERIMENTAL

Occupational Performance Coaching delivered by telephone

Behavioral: Occupational Performance Coaching

Waitlist control

NO INTERVENTION

Intervention provided after post intervention assessment

Interventions

Six sessions of OPC delivered by telephone over 10 weeks.

Also known as: OPC
OPC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • able to participate in coaching in English.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location

Related Publications (1)

  • Kessler D, Franz M, Malakouti N, Rajachandrakumar R, Baharnoori M, Finlayson M. Randomized Controlled Trial of Occupational Performance Coaching for Adults With Multiple Sclerosis. Arch Phys Med Rehabil. 2024 Sep;105(9):1649-1656. doi: 10.1016/j.apmr.2024.05.022. Epub 2024 Jun 6.

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Dorothy Kessler

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: Waitlist control trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 19, 2021

First Posted

June 1, 2021

Study Start

October 1, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

April 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations