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Completed

NCT Number: NCT04552561

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

My MS Toolkit

Behavioral

My MS Toolkit, a web-based self-management intervention designed to help persons with Multiple Sclerosis self-manage fatigue, pain, and depressed mood.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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)

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 17, 2020
Registry last updated
Sep 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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