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

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Behavioral: My MS Toolkit

• Registration Number: NCT04552561
• Lead Sponsor: University of Michigan

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-11
• Study First Posted: 2020-09-17
• Study Start: 2020-10-19
• Primary Completion: 2021-01-18
• Study Completion: 2021-01-18
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-24
• Last Update Posted: 2021-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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:

  1. Moderate/moderately severe depressive symptoms
  2. Chronic pain
  3. Presence of significant fatigue symptoms

• Read, speak and understand English.

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Exclusion Criteria

• Significant cognitive impairment
• Current psychotherapy for symptoms

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
My MS Toolkit	My MS Toolkit	10 Participants asked to use My MS Toolkit and meet weekly with a study coach via telephone.

Primary Outcome Measures

Name	Time	Method
Acceptability/Feasibility of the the coached version of My MS Toolkit	Post-treatment, approximately week 8	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.

Secondary Outcome Measures

Name	Time	Method
Impact My MS Toolkit: Change in depressive symptoms as measured by the Patient Health Questionnaire depression scale	Pre-treatment and Post-treatment, approximately week 8	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.
Impact My MS Toolkit: Change in pain interference as measured by The Brief Pain Inventory Short Form	Pre-treatment and Post-treatment, approximately week 8	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.
Change in self-efficacy for managing symptoms as measured by the University of Washington Self-Efficacy Scale	Pre-treatment and Post-treatment, approximately week 8	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)
Impact of My MS Toolkit: Change in fatigue	Pre-treatment and Post-treatment, approximately week 8	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.
Participant perception of change	Post-treatment, approximately week 8	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.

Trial Locations

Locations (1)

The University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States