My MS Toolkit + Coaching: A Guided Web-based Symptom Self-Management Program for People With MS
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Acceptability/Feasibility of the the coached version of My MS Toolkit
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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:
- •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
Arms & Interventions
My MS Toolkit
10 Participants asked to use My MS Toolkit and meet weekly with a study coach via telephone.
Intervention: My MS Toolkit (Behavioral)
Outcomes
Primary Outcomes
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
- Impact My MS Toolkit: Change in depressive symptoms as measured by the Patient Health Questionnaire depression scale(Pre-treatment and Post-treatment, approximately week 8)
- Impact My MS Toolkit: Change in pain interference as measured by The Brief Pain Inventory Short Form(Pre-treatment and Post-treatment, approximately week 8)
- Change in self-efficacy for managing symptoms as measured by the University of Washington Self-Efficacy Scale(Pre-treatment and Post-treatment, approximately week 8)
- Impact of My MS Toolkit: Change in fatigue(Pre-treatment and Post-treatment, approximately week 8)
- Participant perception of change(Post-treatment, approximately week 8)
Investigators
Anna Kratz
Associate Professor of Physical Medicine and Rehabilitation
University of Michigan