My MS Toolkit: a Symptom Self-management Program for Multiple Sclerosis

Not Applicable

Completed

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

• Registration Number: NCT03708276
• Lead Sponsor: University of Michigan

Brief Summary

My MS Toolkit is a web-based symptom self-management program for persons with multiple sclerosis.

This study is evaluating various aspects of My MS Toolkit 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 12 weeks. Participants will also be asked to complete online surveys throughout the study.

The My MS Toolkit includes 8 modules that describe symptom self-management strategies. Participants will explore the My MS Toolkit on their own, following the prompts and guides built into the program, and 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.

Study Timeline

• Study First Submitted: 2018-10-12
• Study First Submitted QC: 2018-10-16
• Study First Posted: 2018-10-17
• Study Start: 2019-02-26
• Primary Completion: 2019-09-25
• Study Completion: 2019-09-25
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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	20 Participants asked to use My MS Toolkit.

Primary Outcome Measures

Name	Time	Method
Acceptability of My MS Toolkit	week 12-week 14	Assessed by the Patient Satisfaction Evaluation Scale, 12 question scale where each response score ranges from 4 to 1 and the total score ranges from 48 to 12. Higher scores indicate increased satisfaction.
Feasibility of My MS Toolkit	up to week 12	Assessed by the treatment adherence questionnaire that consists of 5 questions that assess: 1) how many times the participant accessed the website in the prior two weeks; 2) how many minutes the participant spent on the website; 3) which parts of the website the participant accessed; 4) which activities the participant engaged in; and 5) which skill from the website the participant used. The items on this questionnaire will be used to describe the use of the website for assessing treatment adherence by participants in the study.

Secondary Outcome Measures

Name	Time	Method
Impact My MS Toolkit: Change in pain interference	up to 14 weeks	The 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.
Impact My MS Toolkit: Change in depressive symptoms	up to 14 weeks	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.
Change in self-efficacy for managing symptoms	up to 14 weeks	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- and post-treatment, up to 14 weeks	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	week 12-14	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)

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