My MS Toolkit: a Symptom Self-management Program for Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Testing a New Multiple Sclerosis Specific Web-based Symptom Self-management Program: My MS Toolkit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03708276
• Other study ID #: HUM00146844
• Secondary ID: W81XWH-17-1-0367
• Status: Completed
• Phase: N/A
• Start date: February 26, 2019
• Est. completion date: September 25, 2019

Study information

• Verified date: July 2023
• 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 25, 2019
• Est. primary completion date: September 25, 2019
• 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
• Sclerosis

Intervention

Other:
• 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	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of My MS Toolkit	Assessed by the Patient Satisfaction Evaluation Scale, 12 question scale where each response score ranges from 4 to 1 and the total score ranges from 48 to 12. Higher scores indicate increased satisfaction.	week 12-week 14
Primary	Feasibility of My MS Toolkit	Assessed by the treatment adherence questionnaire that consists of 5 questions that assess: 1) how many times the participant accessed the website in the prior two weeks; 2) how many minutes the participant spent on the website; 3) which parts of the website the participant accessed; 4) which activities the participant engaged in; and 5) which skill from the website the participant used. The items on this questionnaire will be used to describe the use of the website for assessing treatment adherence by participants in the study.	up to week 12
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- and post-treatment, up to 14 weeks
Secondary	Impact My MS Toolkit: Change in pain interference	The 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.	up to 14 weeks
Secondary	Impact My MS Toolkit: Change in depressive symptoms	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.	up to 14 weeks
Secondary	Change in self-efficacy for managing symptoms	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)	up to 14 weeks
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.	week 12-14