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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03708276
Enrollment
20
Registered
2018-10-17
Start date
2019-02-26
Completion date
2019-09-25
Last updated
2023-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Self-management, Web-based program

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.

Interventions

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

Sponsors

United States Department of Defense
CollaboratorFED
University of Michigan
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Acceptability of My MS Toolkitweek 12-week 14Assessed 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 Toolkitup to week 12Assessed 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

MeasureTime frameDescription
Impact My MS Toolkit: Change in depressive symptomsup to 14 weeksThe 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 of My MS Toolkit: Change in fatiguePre- and post-treatment, up to 14 weeksThe 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 changeweek 12-14Perception 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.
Change in self-efficacy for managing symptomsup to 14 weeksChanges 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 My MS Toolkit: Change in pain interferenceup to 14 weeksThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026