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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dorothy Kessler

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 6032454

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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