NCT04552561

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
Completed

Started Oct 2020

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

September 1, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 17, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

October 19, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2021

Completed
Last Updated

September 27, 2021

Status Verified

September 1, 2021

Enrollment Period

3 months

First QC Date

September 1, 2020

Last Update Submit

September 24, 2021

Conditions

Multiple Sclerosis

Keywords

Self-managementWeb-based program

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Impact of My MS Toolkit: Change in fatigue

    Pre-treatment and Post-treatment, approximately week 8

  • Impact My MS Toolkit: Change in pain interference as measured by The Brief Pain Inventory Short Form

    Pre-treatment and Post-treatment, approximately week 8

  • Impact My MS Toolkit: Change in depressive symptoms as measured by the Patient Health Questionnaire depression scale

    Pre-treatment and Post-treatment, approximately week 8

  • Change in self-efficacy for managing symptoms as measured by the University of Washington Self-Efficacy Scale

    Pre-treatment and Post-treatment, approximately week 8

  • Participant perception of change

    Post-treatment, approximately week 8

Study Arms (1)

My MS Toolkit

EXPERIMENTAL

10 Participants asked to use My MS Toolkit and meet weekly with a study coach via telephone.

Behavioral: My MS Toolkit

Interventions

My MS ToolkitBEHAVIORAL

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)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

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

September 1, 2020

First Posted

September 17, 2020

Study Start

October 19, 2020

Primary Completion

January 18, 2021

Study Completion

January 18, 2021

Last Updated

September 27, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)