- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05629936
Improving Medication Therapy Through a Digital Interdisciplinary Medicine Therapy Optimisation Model (MTO)
April 28, 2026 updated by: Maria Gustafsson, Umeå University
Improving Medication Therapy and Patient Involvement Through a Digital Interdisciplinary Model Among Old People in Primary Care Living in Sparsely Populated Regions in Sweden
In this study, a telepharmacy service in primary care for home-living older adults in Northern Sweden's rural areas will be developed and evaluated.
The primary objective is to evaluate the effect of the service regarding the identification, classification, and resolution of medication-related problems (MRPs).
Secondary objectives are to evaluate participants' medication adherence, health-related quality of life, and beliefs about medicines through self-report questionnaires.
The telepharmacy service include medication interviews, structured medication reviews, interdisciplinary patient-centred discussions, and follow-ups.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
Participants that meet the inclusion criteria will be invited to participate in the study via mail.
The participants will also receive three validated questionnaires; Medication Adherence Report Scale-5 (MARS-5), EuroQol-5 Dimension-5 Level questionnaire (EQ-5D-5L) and The Beliefs about Medicines Questionnaire (BMQ) to fill in prior to initiation of the study, to collect baseline data.
The intervention consists of several steps, and all meetings will be conducted through video conferencing via a secure virtual care platform.
Initially, the participant will have a medication interview with a clinical pharmacist, Next, the clinical pharmacist conducts a structured medication review based on information from the interview and the participant's medical records and laboratory values.
The clinical pharmacist and the participant's primary care physician will then have a video-based interdisciplinary meeting.
During this meeting, the clinical pharmacist presents recommendations to resolve potential MRPs, and the physician may accept or reject the pharmacist's recommendations.
The primary-care physician informs the participant about any changes in their medication therapy and follows-up and monitors these changes.
Video-based follow-up meetings between the participant and the clinical pharmacist will take place 1-2, 4 and 12 weeks after the first video-based meeting.
Additional meetings can be scheduled, if requested by the participant, or if considered necessary by the clinical pharmacist.
The clinical pharmacist will also conduct medical record reviews once every two weeks during the 12-week intervention period.
At 12 weeks, after the last follow-up, the participant will be asked to fill in the three questionnaires one more time.
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Storuman, Sweden
- Storuman healthcare centre
-
Åsele, Sweden
- Åsele healthcare centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Using five or more prescribed medications and/or considered as a potential candidate by the primary care physician.
- Living at home (i.e not in a nursing home)
- Registered at primary healthcare centres in rural municipalities within Västerbotten County (and neighbouring counties if necessary)
Exclusion Criteria:
- Do not speak Swedish
- Unable to communicate
- Has a confirmed major neurocognitive disorder
- Receives palliative care
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Digital intervention
Video-based telepharmacy service
|
Video-based medication interviews, structured medication reviews, interdisciplinary patient-centred discussions, follow-ups
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identification and classfication of medication-related problems
Time Frame: The 12-week intervention period
|
Classification of mediation-related problems according to a modified version of the classification system by Cipolle et al (1998).
|
The 12-week intervention period
|
|
Resolution of medication-related problems
Time Frame: 12-week intervention period
|
The clinical pharmacists' recommendations to resolve medication-related problems will be classified according to a modified version of a system developed by the French Society of Clinical pharmacy.
Physicians' acceptance rate of pharmacists' recommendations will be classified.
The acceptance rate will be classified as accepted recommendation, rejected recommendation, or unknown.
|
12-week intervention period
|
|
Intra-individual change in self-reported medication adherence: Medication Adherence Report Scale-5 (MARS-5)
Time Frame: Baseline and 12 weeks
|
Assessing self-reported medication adherence through the MARS-5 questionnaire.
Total score ranging between 5 and 25, with higher scores indicating a higher level of medication adherence.
|
Baseline and 12 weeks
|
|
Intra-individual change in self-reported health-related quality of life: EuroQol-5 Dimension-5 Level questionnaire (EQ-5D-5L)
Time Frame: Baseline and 12 weeks
|
Assessing health-related quality of life through the EQ-5D-5L-questionnaire.
The questionnaire consists of five questions regarding self-perceived quality of life, and a visual analogue scale on which the respondents evaluate their own health status on a scale of 0-100.
|
Baseline and 12 weeks
|
|
Intra-individual change in self-reported beliefs about medicines: The Beliefs about Medicines Questionnaire (BMQ)
Time Frame: Baseline and 12 weeks
|
Assessing beliefs about medicines through the BMQ.
The questionnaire consists of two different scales; BMQ-General assesses the respondent's beliefs about medicines in general and BMQ-Specific evaluates the individual's beliefs about medicines prescribed for their own use.
|
Baseline and 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Maria Gustafsson, Ph.D, Department of Medical and Translational Biology, Umeå University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 22, 2023
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2028
Study Registration Dates
First Submitted
November 7, 2022
First Submitted That Met QC Criteria
November 17, 2022
First Posted (Actual)
November 29, 2022
Study Record Updates
Last Update Posted (Actual)
May 5, 2026
Last Update Submitted That Met QC Criteria
April 28, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UMU-MTO-2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data (IPD) will not be shared or publicly available due to privacy and ethical restrictions.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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