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

September 24, 2021 updated by: Anna Kratz, University of Michigan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • 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

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • The University of Michigan

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Exclusion Criteria:

  • Significant cognitive impairment
  • Current psychotherapy for symptoms

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability/Feasibility of the the coached version of My MS Toolkit
Time Frame: 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.
Post-treatment, approximately week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of My MS Toolkit: Change in fatigue
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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)
Pre-treatment and Post-treatment, approximately week 8
Participant perception of change
Time Frame: 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.
Post-treatment, approximately week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

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)

October 19, 2020

Primary Completion (Actual)

January 18, 2021

Study Completion (Actual)

January 18, 2021

Study Registration Dates

First Submitted

September 1, 2020

First Submitted That Met QC Criteria

September 11, 2020

First Posted (Actual)

September 17, 2020

Study Record Updates

Last Update Posted (Actual)

September 27, 2021

Last Update Submitted That Met QC Criteria

September 24, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00184319

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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