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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Sweden
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Digital intervention
Video-based telepharmacy service
Other: Telepharmacy service
Video-based medication interviews, structured medication reviews, interdisciplinary patient-centred discussions, follow-ups

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Umeå University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Region Västerbotten

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 22, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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