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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
500
Medisinstart is a counseling service in pharmacies where patients who start taking a new medicine receive two follow-up consultations with a pharmacist.
Ryfylke apotek
Rennesøy, Rennesøy, Norway
RECRUITINGApotek 1 Veakrossen
Veavåg, Veavåg, Norway
RECRUITINGVitusapotek Åfjord
Åfjord, Norway
RECRUITINGApotek 1 Andslimoen
Bardufoss, Norway
RECRUITINGApotek 1 Brandbu
Brandbu, Norway
RECRUITINGApotek 1 Brummundal
Brumunddal, Norway
RECRUITINGSykehusapoteket i Drammen
Drammen, Norway
RECRUITINGVitusapotek Gjøvik
Gjøvik, Norway
RECRUITINGVitusapotek Jessheim
Jessheim, Norway
RECRUITINGBoots apotek Kløfta
Kløfta, Norway
RECRUITING...and 9 more locations
HbA1c
Change in HbA1c-level from baseline to 6 months after initiation of a new medication for type 2 diabetes.
Time frame: 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.
Time frame: At baseline and 12 months after initation of the new medication for type 2 diabetes.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At baseline and 6 and 12 months after initiation of the new medication for type 2 diabetes
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