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Enrolling by Invitation

NCT Number: NCT05629936

Improving Medication Therapy Through a Digital Interdisciplinary Medicine Therapy Optimisation Model

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.

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Key information

Conditions

Medication-related Problems Beliefs About Medicines Health-Related Quality of Life Self-reported Medication Adherence

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Storuman healthcare centre, Storuman, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telepharmacy service

Other

Video-based medication interviews, structured medication reviews, interdisciplinary patient-centred discussions, follow-ups

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Region Västerbotten

Registry information

Official study 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

Acronym: MTO

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Nov 29, 2022
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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