Clinical trial NCT06273657: Effects of Medisinstart for Type 2 Diabetes
Official title: Effects of Medisinstart for Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Medication related problems
Adherence
Type 2 diabetes
Pharmacist-led intervention
Consultation
Pharmacy
Lead sponsor: Apokus AS
Sponsor class: OTHER
Collaborators: name: Norwegian Pharmacy Association
First posted: 2024-02-22
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: HbA1c
timeFrame: At baseline and 6 months after initation of the new medication for type 2 diabetes.
measure: HbA1c
timeFrame: At baseline and 12 months after initation of the new medication for type 2 diabetes.
Secondary outcomes:
measure: Self-reported adherence
timeFrame: 6 and 12 months after initiation of the new medication for type 2 diabetes
measure: Self-reported adherence
timeFrame: 6 and 12 months after initiation of the new medication for type 2 diabetes
measure: Frequency of medication-related problems
timeFrame: At the first and second Medisinstart consultations and 12 months after initiation of the new medication for type 2 diabetes
measure: Patients' beliefs about their medicines
timeFrame: At baseline and 6 months after initation of the new medication for type 2 diabetes
measure: Diabetes Self-Management
timeFrame: 12 months after initiation of the new medication for type 2 diabetes
measure: Diabetes Treatment Satisfaction
timeFrame: At baseline and 6 and 12 months after initiation of the new medication for type 2 diabetes
Other outcomes:
Locations:
city: Bardufoss
country: Norway
facility: Apotek 1 Andslimoen
city: Brandbu
country: Norway
facility: Apotek 1 Brandbu
city: Brumunddal
country: Norway
facility: Apotek 1 Brummundal
city: Drammen
country: Norway
facility: Sykehusapoteket i Drammen
city: Gjøvik
country: Norway
facility: Vitusapotek Gjøvik
city: Jessheim
country: Norway
facility: Vitusapotek Jessheim
city: Kløfta
country: Norway
facility: Boots apotek Kløfta
city: Leksvik
country: Norway
facility: Vitusapotek Leksvik
city: Lena
country: Norway
facility: Apotek 1 Lena
city: Loddefjord
country: Norway
facility: Boots apotek Loddefjord
city: Oslo
country: Norway
facility: Sykehusapoteket i Oslo, Aker
city: Oslo
country: Norway
facility: Vitusapotek Røa
city: Rennesøy
country: Norway
facility: Ryfylke apotek
city: Tromsø
country: Norway
facility: Vitusapotek Jekta
city: Trondheim
country: Norway
facility: Sykehusapoteket i Trondheim
city: Ulefoss
country: Norway
facility: Vitusapotek Ulefoss
city: Veavåg
country: Norway
facility: Apotek 1 Veakrossen
city: Åfjord
country: Norway
facility: Vitusapotek Åfjord
city: Øystese
country: Norway
facility: Boots apotek Linnea
Study officials:
affiliation: Head of Research and Development
name: Sara Bremer, PhD
role: PRINCIPAL_INVESTIGATOR
References: