Clinical trial NCT04552561: My MS Toolkit + Coaching: A Guided Web-based Symptom Self-Management Program for People With MS
Official title: My MS Toolkit + Coaching: A Guided Web-based Symptom Self-Management Program for People With MS
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
First posted: 2020-09-17
Enrollment: 5
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 (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.

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/Feasibility of the the coached version of My MS Toolkit
timeFrame: Post-treatment, approximately week 8
Secondary outcomes:
measure: Impact of My MS Toolkit: Change in fatigue
timeFrame: Pre-treatment and Post-treatment, approximately week 8
measure: Impact My MS Toolkit: Change in pain interference as measured by The Brief Pain Inventory Short Form
timeFrame: Pre-treatment and Post-treatment, approximately week 8
measure: Impact My MS Toolkit: Change in depressive symptoms as measured by the Patient Health Questionnaire depression scale
timeFrame: Pre-treatment and Post-treatment, approximately week 8
measure: Change in self-efficacy for managing symptoms as measured by the University of Washington Self-Efficacy Scale
timeFrame: Pre-treatment and Post-treatment, approximately week 8
measure: Participant perception of change
timeFrame: Post-treatment, approximately week 8
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Anna Kratz
role: PRINCIPAL_INVESTIGATOR
References: