Effects of Medisinstart for Type 2 Diabetes
1 other identifier
interventional
500
1 country
19
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes
Started Feb 2024
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2024
CompletedStudy Start
First participant enrolled
February 7, 2024
CompletedFirst Posted
Study publicly available on registry
February 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2026
CompletedFebruary 22, 2024
February 1, 2024
2 years
February 1, 2024
February 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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 Outcomes (6)
Self-reported adherence
6 and 12 months after initiation of the new medication for type 2 diabetes
Self-reported adherence
6 and 12 months after initiation of the new medication for type 2 diabetes
Frequency of medication-related problems
At the first and second Medisinstart consultations and 12 months after initiation of the new medication for type 2 diabetes
Patients' beliefs about their medicines
At baseline and 6 months after initation of the new medication for type 2 diabetes
Diabetes Self-Management
12 months after initiation of the new medication for type 2 diabetes
- +1 more secondary outcomes
Study Arms (2)
Medisinstart
EXPERIMENTALControl
NO INTERVENTIONInterventions
Medisinstart is a counseling service in pharmacies where patients who start taking a new medicine receive two follow-up consultations with a pharmacist.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Apokus ASlead
- Norwegian Pharmacy Associationcollaborator
Study Sites (19)
Ryfylke apotek
Rennesøy, Rennesøy, 4150, Norway
Apotek 1 Veakrossen
Veavåg, Veavåg, 4276, Norway
Vitusapotek Åfjord
Åfjord, 7170, Norway
Apotek 1 Andslimoen
Bardufoss, 9325, Norway
Apotek 1 Brandbu
Brandbu, 2760, Norway
Apotek 1 Brummundal
Brumunddal, 2380, Norway
Sykehusapoteket i Drammen
Drammen, 3004, Norway
Vitusapotek Gjøvik
Gjøvik, 2806, Norway
Vitusapotek Jessheim
Jessheim, 2050, Norway
Boots apotek Kløfta
Kløfta, 2040, Norway
Vitusapotek Leksvik
Leksvik, 7120, Norway
Apotek 1 Lena
Lena, 2850, Norway
Boots apotek Loddefjord
Loddefjord, 5171, Norway
Sykehusapoteket i Oslo, Aker
Oslo, 0586, Norway
Vitusapotek Røa
Oslo, 0751, Norway
Vitusapotek Jekta
Tromsø, 9015, Norway
Sykehusapoteket i Trondheim
Trondheim, 7030, Norway
Vitusapotek Ulefoss
Ulefoss, 3830, Norway
Boots apotek Linnea
Øystese, 5610, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sara Bremer, PhD
Head of Research and Development
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2024
First Posted
February 22, 2024
Study Start
February 7, 2024
Primary Completion
February 1, 2026
Study Completion
February 1, 2026
Last Updated
February 22, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share