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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06273657
Other study ID # Apokus-002
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 7, 2024
Est. completion date February 2026

Study information

Verified date February 2024
Source Apokus AS
Contact Sara Bremer, PhD
Phone 21620200
Email sara@apokus.no
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Medisinstart is a counseling service in pharmacies where patients who start taking a new medicine receive two follow-up appointments with a pharmacist. The aim of the service is to promote correct medication use and increase patient adherence. The effect of Medisinstart has previously been studied among patients starting a new cardiovascular drug. The aim of the project is to map the effects of Medisinstart among patients starting a new medication for type 2 diabetes. Knowledge about the effects of Medisinstart is important in order to maximize the benefits of the service for patients and society. The project is being conducted as a randomized controlled trial among adult patients starting a new medication for type 2 diabetes. The intervention group receives Medisinstart, while the control group only receives prescription dispensing as normal. Data collection includes HbA1c analysis in blood samples and responses to questionnaires. HbA1c is an established measure of glycemic control.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date February 2026
Est. primary completion date February 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Extracted a new drug/active substance (A10A/A10B) for type 2 diabetes - Age = 18 years - The drugs are administered by the patient/relatives - Good command of Norwegian, both written and spoken Exclusion Criteria: - Inability to understand and/or complete consent forms, questionnaires and/or other patient-oriented materials - Not able to attend physical appointments in the pharmacy - Not given written consent to participate in the study - Diabetes medication is administered by a healthcare professional - Known pregnancy - HbA1c is unsuitable as an average measure of blood glucose at baseline - Received initiation of medication for type 2 diabetes within the last year - Ongoing participation in other studies involving similar interventions to increase adherence and ensure correct medication use

Study Design


Intervention

Other:
Medisinstart
Medisinstart is a counseling service in pharmacies where patients who start taking a new medicine receive two follow-up consultations with a pharmacist.

Locations

Country Name City State
Norway Vitusapotek Åfjord Åfjord
Norway Apotek 1 Andslimoen Bardufoss
Norway Apotek 1 Brandbu Brandbu
Norway Apotek 1 Brummundal Brumunddal
Norway Sykehusapoteket i Drammen Drammen
Norway Vitusapotek Gjøvik Gjøvik
Norway Vitusapotek Jessheim Jessheim
Norway Boots apotek Kløfta Kløfta
Norway Vitusapotek Leksvik Leksvik
Norway Apotek 1 Lena Lena
Norway Boots apotek Loddefjord Loddefjord
Norway Sykehusapoteket i Oslo, Aker Oslo
Norway Vitusapotek Røa Oslo
Norway Boots apotek Linnea Øystese
Norway Ryfylke apotek Rennesøy
Norway Vitusapotek Jekta Tromsø
Norway Sykehusapoteket i Trondheim Trondheim
Norway Vitusapotek Ulefoss Ulefoss
Norway Apotek 1 Veakrossen Veavåg

Sponsors (2)

Lead Sponsor Collaborator
Apokus AS Norwegian Pharmacy Association

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary HbA1c Change in HbA1c-level from baseline to 6 months after initiation of a new medication for type 2 diabetes. At baseline and 6 months after initation of the new medication for type 2 diabetes.
Primary HbA1c Change in HbA1c-level from baseline to 12 months after initiation of a new medication for type 2 diabetes. At baseline and 12 months after initation of the new medication for type 2 diabetes.
Secondary Self-reported adherence Adherence will be measured by a Norwegian translation of the MARS-5 questionnaire. The total MARS-5 score can have values from 5-25, with higher scores indicating higher adherence. 6 and 12 months after initiation of the new medication for type 2 diabetes
Secondary Self-reported adherence Adherence will be measured by a Norwegian translations of the question: "People often miss taking doses of their medicines, for a wide range of reasons. Have you missed any doses of your new medicine the last week?" The question will be answered by yes/no. 6 and 12 months after initiation of the new medication for type 2 diabetes
Secondary Frequency of medication-related problems Pharmacists will report identified medication-related problems (MRPs) in a structured self-developed electronic questionnaire. The MRP categories in the questionnaire are based on the MRP classification presented by Ruths et al. (Tidsskr Nor Laegeforen. 2007 Nov 29;127(23):3073-6). The different MRP categories will be reported as identified or not identified in the consultations. At the first and second Medisinstart consultations and 12 months after initiation of the new medication for type 2 diabetes
Secondary Patients' beliefs about their medicines Patients' beliefs about their medicines will be measured by a validated Norwegian translation of the Beliefs about Medicines Questionnaire (BMQ). The BMQ general comprises three subscales, Harm, Overuse and Benefit, and the total score of each subscale ranges from 4 to 20. The BMQ specific comprises two subscales, Concerns and Necessity, and the total score of each subscale ranges from 5 to 25. Higher scores indicate stronger beliefs in the concepts represented by the subscale. At baseline and 6 months after initation of the new medication for type 2 diabetes
Secondary Diabetes Self-Management Diabetes Self-Management will be measured by a validated Norwegian translation of the Diabetes Self-Management Questionnaire-Revised (DSMQ-R). The scores are summed and transformed into a 1-10 scale for each of the following activities: "eating behavior", "medication use", "glucose monitoring", "physical activity" and "interaction with treating physician/healthcare professional". In addition, a total score is calculated as an overall measure of the patient's diabetes self-management. Values in the upper part of the scale indicate good self-care. 12 months after initiation of the new medication for type 2 diabetes
Secondary Diabetes Treatment Satisfaction Diabetes Treatment Satisfaction will be measured by a validated Norwegian translation of the Diabetes Treatment Satisfaction Questionnaire (DTSQ). The scores range from 0 to 36 where higher scores indicate greater satisfaction with treatment. At baseline and 6 and 12 months after initiation of the new medication for type 2 diabetes
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