- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07518381
Medication Understanding in MS (MUMS)
Home-based Assessment of Medication Understanding and Use in People With Multiple Sclerosis
The goal of this observational study is to learn how people with multiple sclerosis (MS) understand, organise, and use their medicines at home. The study aims to explore how people take their prescribed and non-prescribed medicines, what challenges they experience, and whether any safety issues arise in day-to-day medication use.
Participants will take part in one home visit with trained student researchers. During the visit, researchers will review all medicines and supplements the participant uses, ask about routines and any difficulties, check medication packaging with permission, and ask a brief question about memory. No treatment changes will be made. Information will be reviewed by a senior clinician, and any safety concerns will be shared with the participant's usual healthcare team.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Laura Edwards, FRCP PhD
- Phone Number: 01332258238
- Email: laura.edwards@nottingham.ac.uk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults aged 18 years and over with a confirmed diagnosis of multiple sclerosis
- Living in the community (not in residential care)
- Taking at least one prescribed medication
- Able to provide informed consent or, for those without capacity to provide informed consent, with a consultee available to provide consultee declaration and provide information during home-based medication review
- Willing and able to participate in a home-based medication review
Exclusion Criteria:
- Severe cognitive or communication impairment without a consultee to provide consultee declaration and medication-related information
- Participants for whom a home visit is deemed unsafe
- Non-English speakers
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
People with multiple sclerosis
Adults with multiple sclerosis living in the community who will receive a single home-based medication review.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Medication Burden (Descriptive)
Time Frame: Baseline
|
Total number of prescribed and non-prescribed medications and supplements used by each participant, recorded during the home-based medication review.
This includes dose, frequency, route, and source of each item.
The outcome will be summarised descriptively (counts, means, ranges).
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Medication Adherence (MARS-5 Score)
Time Frame: Baseline
|
Self-reported adherence measured using the 5-item Medication Adherence Report Scale (MARS-5).
Scores range from 5 to 25, with higher scores indicating better adherence.
Results will be summarised descriptively.
|
Baseline
|
|
Medication-Related Challenges
Time Frame: Baseline
|
Proportion of participants reporting difficulties with medication supply, administration, formulation, or perceived effectiveness, based on structured trigger questions.
Reported descriptively.
|
Baseline
|
|
Subjective Cognitive Decline (Single-Item Question)
Time Frame: Baseline
|
("Yes"/"No") to the validated single-item subjective cognitive decline question ("Do you feel you have more problems with your memory than most?").
Used to contextualise medication-taking behaviours.
Summarised descriptively.
|
Baseline
|
|
Medication Organisation and Use of Aids
Time Frame: Baseline
|
Use of medication aids such as dosette boxes, blister packs, phone reminders, or charts.
Recorded as present/absent and described using frequencies.
|
Baseline
|
|
Medication Storage and Safety Issues
Time Frame: Baseline
|
Number and type of potential safety issues identified during the home visit, including expired medicines, duplicate supplies, unmonitored supplements, or storage concerns.
Summarised descriptively.
|
Baseline
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26008
- 368655 (Other Identifier: IRAS)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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