My MS Toolkit + Coaching: A Guided Web-based Symptom Self-Management Program for People With MS
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
My MS Toolkit
Sponsored by

About this trial
This is an interventional health services research trial for Multiple Sclerosis focused on measuring Self-management, Web-based program
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:
- 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
Sites / Locations
- The University of Michigan
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
My MS Toolkit
Arm Description
10 Participants asked to use My MS Toolkit and meet weekly with a study coach via telephone.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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)
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.
Full Information
NCT ID
NCT04552561
First Posted
September 1, 2020
Last Updated
September 24, 2021
Sponsor
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT04552561
Brief Title
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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 19, 2020 (Actual)
Primary Completion Date
January 18, 2021 (Actual)
Study Completion Date
January 18, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Self-management, Web-based program
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
My MS Toolkit
Arm Type
Experimental
Arm Description
10 Participants asked to use My MS Toolkit and meet weekly with a study coach via telephone.
Intervention Type
Behavioral
Intervention Name(s)
My MS Toolkit
Intervention Description
My MS Toolkit, a web-based self-management intervention designed to help persons with Multiple Sclerosis self-manage fatigue, pain, and depressed mood.
Primary Outcome Measure Information:
Title
Acceptability/Feasibility of the the coached version of My MS Toolkit
Description
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.
Time Frame
Post-treatment, approximately week 8
Secondary Outcome Measure Information:
Title
Impact of My MS Toolkit: Change in fatigue
Description
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.
Time Frame
Pre-treatment and Post-treatment, approximately week 8
Title
Impact My MS Toolkit: Change in pain interference as measured by The Brief Pain Inventory Short Form
Description
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.
Time Frame
Pre-treatment and Post-treatment, approximately week 8
Title
Impact My MS Toolkit: Change in depressive symptoms as measured by the Patient Health Questionnaire depression scale
Description
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.
Time Frame
Pre-treatment and Post-treatment, approximately week 8
Title
Change in self-efficacy for managing symptoms as measured by the University of Washington Self-Efficacy Scale
Description
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)
Time Frame
Pre-treatment and Post-treatment, approximately week 8
Title
Participant perception of change
Description
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.
Time Frame
Post-treatment, approximately week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Kratz
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
My MS Toolkit + Coaching: A Guided Web-based Symptom Self-Management Program for People With MS
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