Effects of Medisinstart for Type 2 Diabetes

February 14, 2024 updated by: Apokus AS
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: At baseline and 6 months after initation of the new medication for type 2 diabetes.
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
Time Frame: At baseline and 12 months after initation of the new medication for type 2 diabetes.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-reported adherence
Time Frame: 6 and 12 months after initiation of the new medication for type 2 diabetes
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
Time Frame: 6 and 12 months after initiation of the new medication for type 2 diabetes
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
Time Frame: At the first and second Medisinstart consultations and 12 months after initiation of the new medication for type 2 diabetes
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
Time Frame: At baseline and 6 months after initation of the new medication for type 2 diabetes
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
Time Frame: 12 months after initiation of the new medication for type 2 diabetes
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
Time Frame: At baseline and 6 and 12 months after initiation of the new medication for type 2 diabetes
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Apokus AS

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Norwegian Pharmacy Association

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sara Bremer, PhD, Head of Research and Development

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 7, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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