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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04552561
Enrollment
5
Registered
2020-09-17
Start date
2020-10-19
Completion date
2021-01-18
Last updated
2021-09-27

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 (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.

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.

Interventions

BEHAVIORALMy 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.

Sponsors

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/Feasibility of the the coached version of My MS ToolkitPost-treatment, approximately week 8Assessed 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

MeasureTime frameDescription
Impact of My MS Toolkit: Change in fatiguePre-treatment and Post-treatment, approximately week 8The 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.
Impact My MS Toolkit: Change in pain interference as measured by The Brief Pain Inventory Short FormPre-treatment and Post-treatment, approximately week 8The 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.
Impact My MS Toolkit: Change in depressive symptoms as measured by the Patient Health Questionnaire depression scalePre-treatment and Post-treatment, approximately week 8The 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 as measured by the University of Washington Self-Efficacy ScalePre-treatment and Post-treatment, approximately week 8Changes measured by the University of Washington Self-Efficacy Scale (UW-SES), higher score indicates higher levels of self-efficacy (total score range: 6-30)
Participant perception of changePost-treatment, approximately week 8Perception 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.

Countries

United States

Outcome results

None listed

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