Effects of Medisinstart for Type 2 Diabetes

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: Medisinstart

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Bremer, PhD; Phone Number: 21620200; Email: sara@apokus.no
• Study Contact Backup: Name: Karine Wabø Ruud, PhD; Phone Number: 21620200; Email: karine@apokus.no

Study Locations

• Norway
  • Bardufoss, Norway, 9325
    • Recruiting
    • Apotek 1 Andslimoen
  • Brandbu, Norway, 2760
    • Recruiting
    • Apotek 1 Brandbu
  • Brumunddal, Norway, 2380
    • Recruiting
    • Apotek 1 Brummundal
  • Drammen, Norway, 3004
    • Recruiting
    • Sykehusapoteket i Drammen
  • Gjøvik, Norway, 2806
    • Recruiting
    • Vitusapotek Gjøvik
  • Jessheim, Norway, 2050
    • Recruiting
    • Vitusapotek Jessheim
  • Kløfta, Norway, 2040
    • Recruiting
    • Boots apotek Kløfta
  • Leksvik, Norway, 7120
    • Recruiting
    • Vitusapotek Leksvik
  • Lena, Norway, 2850
    • Recruiting
    • Apotek 1 Lena
  • Loddefjord, Norway, 5171
    • Recruiting
    • Boots apotek Loddefjord
  • Oslo, Norway, 0586
    • Recruiting
    • Sykehusapoteket i Oslo, Aker
  • Oslo, Norway, 0751
    • Recruiting
    • Vitusapotek Røa
  • Rennesøy, Norway, 4150
    • Recruiting
    • Ryfylke apotek
  • Tromsø, Norway, 9015
    • Recruiting
    • Vitusapotek Jekta
  • Trondheim, Norway, 7030
    • Recruiting
    • Sykehusapoteket i Trondheim
  • Ulefoss, Norway, 3830
    • Recruiting
    • Vitusapotek Ulefoss
  • Veavåg, Norway, 4276
    • Recruiting
    • Apotek 1 Veakrossen
  • Åfjord, Norway, 7170
    • Recruiting
    • Vitusapotek Åfjord
  • Øystese, Norway, 5610
    • Recruiting
    • Boots apotek Linnea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Medisinstart	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Apokus AS
• Collaborators: Norwegian Pharmacy Association
• Investigators: Principal Investigator: Sara Bremer, PhD, Head of Research and Development

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 14, 2024
• First Posted (Actual): February 22, 2024

Study Record Updates

• Last Update Posted (Actual): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Adherence; Type 2 diabetes; Consultation; Pharmacy; Medication related problems; Pharmacist-led intervention
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Apokus-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No