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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04552561
• Other study ID #: HUM00184319
• Status: Completed
• Phase: N/A
• Start date: October 19, 2020
• Est. completion date: January 18, 2021

Study information

• Verified date: September 2021
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: January 18, 2021
• Est. primary completion date: January 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

Behavioral:
• My 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.

Locations

Country	Name	City	State
United States	The University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability/Feasibility of the the coached version of My MS Toolkit	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.	Post-treatment, approximately week 8
Secondary	Impact of My MS Toolkit: Change in fatigue	The 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.	Pre-treatment and Post-treatment, approximately week 8
Secondary	Impact My MS Toolkit: Change in pain interference as measured by The Brief Pain Inventory Short Form	The 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.	Pre-treatment and Post-treatment, approximately week 8
Secondary	Impact My MS Toolkit: Change in depressive symptoms as measured by the Patient Health Questionnaire depression scale	The 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.	Pre-treatment and Post-treatment, approximately week 8
Secondary	Change in self-efficacy for managing symptoms as measured by the University of Washington Self-Efficacy Scale	Changes measured by the University of Washington Self-Efficacy Scale (UW-SES), higher score indicates higher levels of self-efficacy (total score range: 6-30)	Pre-treatment and Post-treatment, approximately week 8
Secondary	Participant perception of change	Perception 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.	Post-treatment, approximately week 8