My MS Toolkit + Coaching: A Guided Web-based Symptom Self-Management Program for People With MS

Study Overview
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Brief Summary
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My MS Toolkit is a web-based symptom self-management program for persons with multiple sclerosis (MS). This study is evaluating various aspects of My MS Toolkit plus coaching and how it impacts symptom self-management in multiple sclerosis. The research team believe that the toolkit will be feasible, acceptable, and beneficial to participants.

Detailed Description
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Study participants will be asked to use a newly developed web-based symptom self-management program, called the My MS Toolkit, for 8 weeks. The My MS Toolkit includes 8 modules that describe symptom self-management strategies. Participants will explore the My MS Toolkit, following the prompts and guides built into the program, and meet with a study coach weekly for 15 to 30-minute telephone-delivered coaching sessions. Participants are encouraged to practice and apply the skills learned. The study can be done from participants' homes using a reliable internet-connected device. No travel is required.

Official Title
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My MS Toolkit + Coaching: A Guided Web-based Symptom Self-Management Program for People With MS

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: My MS Toolkit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Multiple Sclerosis Have access to a reliable, internet-connected device (e.g. computer, tablet). (Note: this study is conducted electronically and is not location dependent.) One or more of the following: Moderate/moderately severe depressive symptoms Chronic pain Presence of significant fatigue symptoms Read, speak and understand English. Exclusion Criteria: Significant cognitive impairment Current psychotherapy for symptoms

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: My MS Toolkit<br>10 Participants asked to use My MS Toolkit and meet weekly with a study coach via telephone. | Behavioral: My MS Toolkit<br>* My MS Toolkit, a web-based self-management intervention designed to help persons with Multiple Sclerosis self-manage fatigue, pain, and depressed mood.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability/Feasibility of the the coached version of My MS Toolkit | Assessed by the Participant Satisfaction Evaluation Survey. This survey is a 17 item scale with one free text item and 16 items with scores ranging from 1-4 (lowest to highest) with total scores ranging from 16-64. Higher scores indicate greater levels of acceptability. | Post-treatment, approximately week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of My MS Toolkit: Change in fatigue | The Modified Fatigue Impact Scale will be used to assess fatigue. It is a self-report survey that contains 21 items. Each item is rated 0-4. Higher scores indicate a greater impact of fatigue on a person's activities. | Pre-treatment and Post-treatment, approximately week 8 | 
| Impact My MS Toolkit: Change in pain interference as measured by The Brief Pain Inventory Short Form | The Brief Pain Inventory Short Form (BPI-SF) is a 9-item questionnaire (15 prompts) with two domains: pain severity and pain interference. The 7 pain interference items have values which range from 0 (does not interfere) to 10 (completely interferes); items are averaged for a scale score range of 0-10, with higher scores indicating more pain interference. | Pre-treatment and Post-treatment, approximately week 8 | 
| Impact My MS Toolkit: Change in depressive symptoms as measured by the Patient Health Questionnaire depression scale | The eight-item Patient Health Questionnaire depression scale (PHQ-8) is established as a valid diagnostic and severity measure for depressive disorders in large clinical studies. Scores range from 0 - 24 and a score of 10 or greater is consistent with at least moderate depressive symptoms. | Pre-treatment and Post-treatment, approximately week 8 | 
| Change in self-efficacy for managing symptoms as measured by the University of Washington Self-Efficacy Scale | Changes measured by the University of Washington Self-Efficacy Scale (UW-SES), higher score indicates higher levels of self-efficacy (total score range: 6-30) | Pre-treatment and Post-treatment, approximately week 8 | 
| Participant perception of change | Perception of change is assessed by the patient global impression of change questionnaire, which is 1 question and responses range from 1-7. Higher numbers indicate greater improvement in condition. | Post-treatment, approximately week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-management, Web-based program