Effects of Medisinstart for Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Effects of Medisinstart for Type 2 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06273657
• Other study ID #: Apokus-002
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

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