Medication-related ProblemsMTONCT05629936
Improving Medication Therapy Through a Digital Interdisciplinary Medicine Therapy Optimisation Model
A study testing Telepharmacy service in people with Medication-related Problems and Self-reported Medication Adherence, run by Umeå University at 2 sites in Sweden.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medication-related Problems, Self-reported Medication Adherence, Health-related Quality of Life
- What is being tested?
- Telepharmacy service
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesSweden
- Study dates
- 22 Nov 2023to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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)
Who cannot join
- Do not speak Swedish
- Unable to communicate
- Has a confirmed major neurocognitive disorder
- Receives palliative care
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Medication-related Problems, Self-reported Medication Adherence, Health-related Quality of Life, Beliefs About Medicines
- Being tested
- Telepharmacy service
- Keywords
- Telemedicine, Medication reconciliation, Clinical pharmacist, Adherence, Telepharmacy, Medication-related problems, Aged, Structured medication review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telepharmacy serviceOther
Video-based medication interviews, structured medication reviews, interdisciplinary patient-centred discussions, follow-ups
| Study group | Role | What they receive |
|---|---|---|
| Digital intervention | Other | Video-based telepharmacy service Receives: Other: Telepharmacy service |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification and classfication of medication-related problems
Classification of mediation-related problems according to a modified version of the classification system by Cipolle et al (1998).
Measured: The 12-week intervention period
Resolution of medication-related problems
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.
Measured: 12-week intervention period
Intra-individual change in self-reported medication adherence: Medication Adherence Report Scale-5 (MARS-5)
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.
Measured: Baseline and 12 weeks
Intra-individual change in self-reported health-related quality of life: EuroQol-5 Dimension-5 Level questionnaire (EQ-5D-5L)
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.
Measured: Baseline and 12 weeks
Intra-individual change in self-reported beliefs about medicines: The Beliefs about Medicines Questionnaire (BMQ)
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.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start22 Nov 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication-related ProblemsStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Västerbotten
- Responsible party
- Principal investigator, Maria Gustafsson, Umeå University
- Investigators
- Maria Gustafsson, Ph.D, Principal investigator, Department of Medical and Translational Biology, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629936
- Sponsor's protocol ID
- UMU-MTO-2022
- Acronym
- MTO
- Status last verified
- Apr 2026
- First submitted
- 7 Nov 2022
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared or publicly available due to privacy and ethical restrictions.
Publications
Westberg A, Andersson P, Sonnerstam E, Mattsson S, Holmner A, Edin-Liljegren A, Gustafsson M. Development and evaluation of a telepharmacy service in primary care for home-living older adults in Northern Sweden's rural areas: protocol for a single-arm interventional study. BMJ Open. 2025 Nov 19;15(11):e110198. doi: 10.1136/bmjopen-2025-110198.
PubMed 41263936
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Medication Therapy and Patient Involvement Through a Digital Interdisciplinary Model Among Old People in Primary Care Living in Sparsely Populated Regions in Sweden
- ClinicalTrials.gov ID
- NCT05629936
- Acronym / sponsor ID
- MTO / UMU-MTO-2022
- Conditions
- Medication-related Problems, Self-reported Medication Adherence, Health-related Quality of Life, Beliefs About Medicines
- Keywords
- Telemedicine, Medication reconciliation, Clinical pharmacist, Adherence, Telepharmacy, Medication-related problems, Aged, Structured medication review
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Region Västerbotten
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 29 Nov 2022 (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.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital intervention | Other | Other: Telepharmacy serviceVideo-based telepharmacy service |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- Do not speak Swedish
- Unable to communicate
- Has a confirmed major neurocognitive disorder
- Receives palliative care
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 |
|---|---|---|
| Telepharmacy serviceVideo-based medication interviews, structured medication reviews, interdisciplinary patient-centred discussions, follow-ups | Other | Digital intervention |
Primary outcome
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).
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Derived from this study: PubMed 41263936Westberg A, Andersson P, Sonnerstam E, Mattsson S, Holmner A, Edin-Liljegren A, Gustafsson M. Development and evaluation of a telepharmacy service in primary care for home-living older adults in Northern Sweden's rural areas: protocol for a single-arm interventional study. BMJ Open. 2025 Nov 19;15(11):e110198. doi: 10.1136/bmjopen-2025-110198.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared or publicly available due to privacy and ethical restrictions.
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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.
Maria Gustafsson, Ph.D principal investigator
Department of Medical and Translational Biology, Umeå University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telepharmacy service in people with Medication-related Problems and Self-reported Medication Adherence, run by Umeå University at 2 sites in Sweden.
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 3 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
Identification and classfication of medication-related problems (time frame: The 12-week intervention period). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05629936, which also lists 1 linked publication.
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 5 May 2026.