NCT03708276

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

February 26, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2019

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

7 months

First QC Date

October 12, 2018

Last Update Submit

July 18, 2023

Conditions

Multiple Sclerosis

Keywords

Self-managementWeb-based program

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (5)

  • Impact of My MS Toolkit: Change in fatigue

    Pre- and post-treatment, up to 14 weeks

  • Impact My MS Toolkit: Change in pain interference

    up to 14 weeks

  • Impact My MS Toolkit: Change in depressive symptoms

    up to 14 weeks

  • Change in self-efficacy for managing symptoms

    up to 14 weeks

  • Participant perception of change

    week 12-14

Study Arms (1)

My MS Toolkit

EXPERIMENTAL

20 Participants asked to use My MS Toolkit.

Other: My MS Toolkit

Interventions

My MS ToolkitOTHER

My MS Toolkit, a web-based self-management intervention designed to help persons with Multiple Sclerosis self-manage fatigue, pain, and depressed mood.

My MS Toolkit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Significant cognitive impairment
  • Current psychotherapy for symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • Kratz AL, Alschuler KN, Williams DA, Ehde DM. Development and pilot testing of a web-based symptom management program for multiple sclerosis: My MS toolkit. Rehabil Psychol. 2021 May;66(2):224-232. doi: 10.1037/rep0000375. Epub 2021 Feb 4.

    PMID: 33539138DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Anna Kratz

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Physical Medicine and Rehabilitation

Study Record Dates

First Submitted

October 12, 2018

First Posted

October 17, 2018

Study Start

February 26, 2019

Primary Completion

September 25, 2019

Study Completion

September 25, 2019

Last Updated

July 20, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)