Multiple SclerosisNCT04552561
My MS Toolkit + Coaching: A Guided Web-based Symptom Self-Management Program for People With MS
A study testing My MS Toolkit in people with Multiple Sclerosis, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- My MS Toolkit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2020to 18 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Significant cognitive impairment
- Current psychotherapy for symptoms
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Michigan
Ann Arbor, Michigan, 48109
About this study
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- My MS Toolkit
- Keywords
- Self-management, Web-based program
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My MS ToolkitBehavioural
My MS Toolkit, a web-based self-management intervention designed to help persons with Multiple Sclerosis self-manage fatigue, pain, and depressed mood.
| Study group | Role | What they receive |
|---|---|---|
| My MS Toolkit | Experimental | 10 Participants asked to use My MS Toolkit and meet weekly with a study coach via telephone. Receives: Behavioral: My MS Toolkit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-treatment, approximately week 8
Secondary outcomes (5)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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)
Measured: Pre-treatment and Post-treatment, approximately week 8
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.
Measured: Post-treatment, approximately week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start19 Oct 2020
- Primary completion18 Jan 2021
- Study completion18 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Kratz, University of Michigan
- Investigators
- Anna Kratz, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552561
- Sponsor's protocol ID
- HUM00184319
- Status last verified
- Sep 2021
- First submitted
- 1 Sep 2020
- Last updated
- 27 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- My MS Toolkit + Coaching: A Guided Web-based Symptom Self-Management Program for People With MS
- ClinicalTrials.gov ID
- NCT04552561
- Acronym / sponsor ID
- HUM00184319
- Conditions
- Multiple Sclerosis
- Keywords
- Self-management, Web-based program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 18 Jan 2021 (actual)
- Study completion
- 18 Jan 2021 (actual)
- First posted
- 17 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| My MS Toolkit | Experimental | Behavioral: My MS Toolkit10 Participants asked to use My MS Toolkit and meet weekly with a study coach via telephone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- Read, speak and understand English.
Key exclusion criteria (2 listed)
- Significant cognitive impairment
- Current psychotherapy for symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| My MS ToolkitMy MS Toolkit, a web-based self-management intervention designed to help persons with Multiple Sclerosis self-manage fatigue, pain, and depressed mood. | Behavioural | My MS Toolkit |
Primary outcome
Acceptability/Feasibility of the the coached version of My MS Toolkit
Time frame: Post-treatment, approximately week 8
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.
5 secondary outcomes
Impact of My MS Toolkit: Change in fatigue
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Pre-treatment and Post-treatment, approximately week 8
Participant perception of change
Time frame: Post-treatment, approximately week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Kratz principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing My MS Toolkit in people with Multiple Sclerosis, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability/Feasibility of the the coached version of My MS Toolkit (time frame: Post-treatment, approximately week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.