Multiple SclerosisNCT04908085
Creating Satisfying Engagement in Daily Life Through Coaching for People With Multiple Sclerosis
A study testing Occupational Performance Coaching in people with Multiple Sclerosis and Quality of Life, run by Dorothy Kessler at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Quality of Life
- What is being tested?
- Occupational Performance Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- able to participate in coaching in English.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Multiple Sclerosis, Quality of Life
- Being tested
- Occupational Performance Coaching
- Keywords
- Coaching
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational Performance CoachingBehavioural
Also called OPC
Six sessions of OPC delivered by telephone over 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| OPC | Experimental | Occupational Performance Coaching delivered by telephone Receives: Behavioral: Occupational Performance Coaching |
| Waitlist control | No intervention | Intervention provided after post intervention assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-intervention, 10 weeks, and 2 months post intervention
Secondary outcomes (4)
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.
Measured: Pre-intervention, 10 weeks, and 2 months post intervention
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.
Measured: Pre-intervention, 10 weeks, and 2 months post intervention
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.
Measured: Pre-intervention, 10 weeks, and 2 months post intervention
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.
Measured: Pre-intervention, 10 weeks, and 2 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start1 Oct 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Waitlist control trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dorothy Kessler
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dorothy Kessler, Queen's University
- Investigators
- Dorothy Kessler, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908085
- Sponsor's protocol ID
- 6032454
- Status last verified
- Apr 2024
- First submitted
- 19 May 2021
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38851554
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating Satisfying Engagement in Daily Life Through Coaching for People With Multiple
- ClinicalTrials.gov ID
- NCT04908085
- Acronym / sponsor ID
- 6032454
- Conditions
- Multiple Sclerosis, Quality of Life
- Keywords
- Coaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Dorothy KesslerUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Waitlist control trial
| Arm | Type | Receives |
|---|---|---|
| OPC | Experimental | Behavioral: Occupational Performance CoachingOccupational Performance Coaching delivered by telephone |
| Waitlist control | No intervention | –Intervention provided after post intervention assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- able to participate in coaching in English.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occupational Performance CoachingAlso: OPCSix sessions of OPC delivered by telephone over 10 weeks. | Behavioural | OPC |
Primary outcome
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.
4 secondary outcomes
Illness Intrusiveness Rating Scale
Time frame: Pre-intervention, 10 weeks, and 2 months post intervention
MS Impact Scale-29
Time frame: 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
Impact on Participation and Autonomy Questionnaire
Time frame: Pre-intervention, 10 weeks, and 2 months post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Derived from this study: PubMed 38851554Kessler 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dorothy Kessler principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational Performance Coaching in people with Multiple Sclerosis and Quality of Life, run by Dorothy Kessler at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Canadian Occupational Performance Measure (time frame: Pre-intervention, 10 weeks, and 2 months post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04908085, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.