Clinical trial NCT03708276: My MS Toolkit: a Symptom Self-management Program for Multiple Sclerosis
Official title: Testing a New Multiple Sclerosis Specific Web-based Symptom Self-management Program: My MS Toolkit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Self-management
Web-based program
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2018-10-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability of My MS Toolkit
timeFrame: week 12-week 14
measure: Feasibility of My MS Toolkit
timeFrame: up to week 12
Secondary outcomes:
measure: Impact of My MS Toolkit: Change in fatigue
timeFrame: Pre- and post-treatment, up to 14 weeks
measure: Impact My MS Toolkit: Change in pain interference
timeFrame: up to 14 weeks
measure: Impact My MS Toolkit: Change in depressive symptoms
timeFrame: up to 14 weeks
measure: Change in self-efficacy for managing symptoms
timeFrame: up to 14 weeks
measure: Participant perception of change
timeFrame: week 12-14
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Anna Kratz
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kratz AL, Alschuler KN, Williams DA, Ehde DM. Development and pilot testing of a web-based symptom management program for multiple sclerosis: My MS toolkit. Rehabil Psychol. 2021 May;66(2):224-232. doi: 10.1037/rep0000375. Epub 2021 Feb 4.