Overview

This trial is active, not recruiting.

Condition cardiovascular diseases
Treatment medisinstart
Sponsor Apokus AS
Collaborator Norwegian Pharmacy Association
Start date October 2014
End date December 2015
Trial size 1480 participants
Trial identifier NCT02261402, Apokus-001

Summary

"Medisinstart" is a new service developed for use in Norwegian pharmacies. It is intended for patients that are about to start a new medicine for a chronic or long-term condition. It is based on research showing that problems with newly prescribed medicines appear rapidly and that a significant portion of patients quickly becomes non-adherent. The service consists of two follow-up consultations with a pharmacist. The first at 1-2 weeks and the second at 3-5 weeks after start of the new medicine.

The main purpose of this study is to investigate whether "Medisinstart" increases patients' adherence to the prescribed medication. Patients' beliefs about their medicines and their motivation for adherence will also be examined. The study also aims at revealing if "Medisinstart" has additional benefits for the patient, the society and the pharmacies.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Patients in this arm will receive the service; Medisinstart
medisinstart
"Medisinstart" is a newly developed pharmacy service for patients about to start a new medicine for a chronic or long-term condition. It consists of two follow-up consultations with a pharmacist. The first at 1-2 weeks and the second at 3-5 weeks after start of the new medicine.
(No Intervention)
Patients in this arm will receive the current pharmacy practice of advice and guidance with their new medicine. This involves dispensing the medicine and briefly providing information regarding its use and potential side-effects.

Primary Outcomes

Measure
Adherence by Morisky 8-item Medication Adherence Scale (MMAS-8) at 7 weeks
time frame: 7 weeks after dispensing the new medicine
Adherence by Morisky 8-item Medication Adherence Scale (MMAS-8) at 18 weeks
time frame: 18 weeks after dispensing the new medicine

Secondary Outcomes

Measure
Self reported adherence at 7 weeks
time frame: 7 weeks after dispensing the new medicine
Adherence by Medication Possession Ratio (MPR) at 18 weeks
time frame: 18 weeks after dispensing the new medicine
Patients' beliefs about their medicines by Beliefs about Medicines Questionnaire (BMQ) at inclusion
time frame: At inclusion
Self reported adherence at 18 weeks
time frame: 18 weeks after dispensing the new medicine
Adherence by Medication Possession Ratio (MPR) at 1 year
time frame: 1 year after dispensing the new medicine
Patients' beliefs about their medicines by Beliefs about Medicines Questionnaire (BMQ) at 7 weeks
time frame: 7 weeks after dispensing the new medicine
Patients' beliefs about their medicines by Beliefs about Medicines Questionnaire (BMQ) at 18 weeks
time frame: 18 weeks after dispensing the new medicine

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: First time prescription for a drug belonging to one of the following groups (ATC-code): - Dabigatran etexilate (B01AE07) - Rivaroxaban (B01AF01) - Apixaban (B01AF02) - Beta blocking agents (C07) - Calcium channel blockers (C08) - Agents acting on the renin-angiotensin system (C09) - HMG CoA reductase inhibitors (statins) (C10AA) Exclusion Criteria: - Prior use (within the last 3 years) of the drug in question independent of strength, dose and formulation

Additional Information

Official title Effectiveness of "Medisinstart" - an Open Randomized Controlled Trial of a Newly Developed Pharmacy Service
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Apokus AS.