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Completed

NCT Number: NCT03708276

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

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.

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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

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 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.

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

Other

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 of My MS Toolkit

    Time frame: 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.

  2. Feasibility of My MS Toolkit

    Time frame: 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 outcomes

  1. Impact of My MS Toolkit: Change in fatigue

    Time frame: 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.

  2. Impact My MS Toolkit: Change in pain interference

    Time frame: 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.

  3. Impact My MS Toolkit: Change in depressive symptoms

    Time frame: 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.

  4. Change in self-efficacy for managing symptoms

    Time frame: 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)

  5. Participant perception of change

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

Testing a New Multiple Sclerosis Specific Web-based Symptom Self-management Program: My MS Toolkit

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 17, 2018
Registry last updated
Jul 20, 2023

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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