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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05629936
Other study ID # UMU-MTO-2022
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 2022
Est. completion date December 2026

Study information

Verified date November 2022
Source Umeå University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study investigates if a digital interdisciplinary medicine therapy optimization (MTO) model in primary care can improve medication therapy, quality of life and adherence among patients >65 years living in sparsley populated areas. The intervention includes digital medication interviews, comprehensive medication reviews, team based patient discussions and follow-ups.


Description:

A pilot study to develop the MTO-model including 10-15 patients, will be carried out and appropriate adjustments to the model will be made before starting the main study. Patients meeting the inclusion criteria will be invited to participate in the study and sent three questionnaires, MARS-5, EQ-5D-5L and BMQ-general, to fill in before starting the intervention. Baseline in this digital intervention is a medication interview with a clinical pharmacist. Based on the information from this interview, journal- and laboratory data, a comprehensive medication review will be conducted and a preliminary proposal discussed in a digital interdisciplinary meeting resulting in a final MTO-plan. The patients will be informed by their physician if any medication changes have been made and follow-up meetings with a pharmacist will take place 1-2,4 and 12 weeks after baseline and in addition of requested by the patients or if the pharmacist consider it necessary. In addition to the prescheduled meetings with the patient, the intervention includes repeated medical journal reviews every second week during the 12-weeks intervention. After the last follow-up at 12 weeks, the patient will be asked to fill in the three questionnaires; MARS-5, EQ-5D-5L and BMQ-general.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 2026
Est. primary completion date December 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - 5 or more medications or recommended by their physician - Living at home (i.e not in nursing home) - Registered at one of seven specified primary care centers Exclusion Criteria: - Do not speak Swedish or unable to communicate - Home care services - Confirmed major NCD - Scheduled for palliative care

Study Design


Related Conditions & MeSH terms


Intervention

Other:
digital interdisciplinary intervention
Digital medication interview, comprehensive medication review, interdisciplinary patient team discussion followed by a MTO-plan, follow-ups

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Umeå University Region Västerbotten

Outcome

Type Measure Description Time frame Safety issue
Primary Change in self-reported health state: EuroQol-5 dimension-5 level questionnaire (EQ-5D-5L) Assessing health-related quality of life through the EQ-5D-5L-questionnaire. EQ VAS score ranging between 0 and 100, with higher score indicating a higher overall self-rated health status. Change in self-reported health state between baseline and 12 weeks
Primary Change in self-reported adherence: Medication Adherence Report Scale-5 (MARS-5) Assessing medication adherence through MARS-5 questionnaire. Total score ranging between 5 and 25, with higher scores indicating a higher level of adherence. Change in self-reported adherence between baseline and 12 weeks
Primary Change in self-reported beliefs about medicines in general: The Beliefs about Medicines Questionnaire - general (BMQ-general) Assessing beliefs about medicines in general through BMQ-general questionnaire. BMQ-general consists of three different subscales (overuse, harm and benefit) with a total score ranging between 4-20 for each subscale. In two of the subscales (overuse and harm) higher scores indicates a more negative orientation towards medicines in general and in the subscale benefit a higher score indicates a more positive orientation towards medicines. Change in self-reported beliefs about medicines between baseline and 12 weeks
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