Type 2 Diabetes
Conditions
Keywords
Medication related problems, Adherence, Type 2 diabetes, Pharmacist-led intervention, Consultation, Pharmacy
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.
Interventions
OTHERMedisinstart
Medisinstart is a counseling service in pharmacies where patients who start taking a new medicine receive two follow-up consultations with a pharmacist.
Sponsors
Norwegian Pharmacy Association
Apokus AS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported adherence | 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. |
| 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 | 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. |
| Patients' beliefs about their medicines | 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. |
| Diabetes Self-Management | 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. |
| Diabetes Treatment Satisfaction | 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. |
Countries
Norway
Contacts
Primary ContactSara Bremer, PhD
Backup ContactKarine Wabø Ruud, PhD
Outcome results
None listed