Skip to main content
OpenTrials
Completed

NCT Number: NCT02261402

Effectiveness of "Medisinstart"

"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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiovascular Diseases Dyslipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Apotek 1 Alta, Alta, Norway

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medisinstart

Other

"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.

Primary outcomes

  1. Adherence by Morisky 8-item Medication Adherence Scale (MMAS-8) at 7 weeks

    Time frame: 7 weeks after dispensing the new medicine

    Adherence will be measured by a validated Norwegian translation of the MMAS-8

  2. Adherence by Morisky 8-item Medication Adherence Scale (MMAS-8) at 18 weeks

    Time frame: 18 weeks after dispensing the new medicine

    Adherence will be measured by a validated Norwegian translation of the MMAS-8

Secondary outcomes

  1. Self reported adherence at 7 weeks

    Time frame: 7 weeks after dispensing the new medicine

    Adherence will be measured by a Norwegian translation 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?"

  2. Adherence by Medication Possession Ratio (MPR) at 18 weeks

    Time frame: 18 weeks after dispensing the new medicine

    Adherence by MPR will be calculated from data collected from the Norwegian Prescription Database

  3. Patients' beliefs about their medicines by Beliefs about Medicines Questionnaire (BMQ) at inclusion

    Time frame: At inclusion

    Patients' beliefs about their medicines will be measured by a validated Norwegian translation of the BMQ

  4. Self reported adherence at 18 weeks

    Time frame: 18 weeks after dispensing the new medicine

    Adherence will be measured by a Norwegian translation 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?"

  5. Adherence by Medication Possession Ratio (MPR) at 1 year

    Time frame: 1 year after dispensing the new medicine

    Adherence by MPR will be calculated from data collected from the Norwegian Prescription Database

  6. 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 will be measured by a validated Norwegian translation of the BMQ

  7. Patients' beliefs about their medicines by Beliefs about Medicines Questionnaire (BMQ) at 18 weeks

    Time frame: 18 weeks after dispensing the new medicine

    Patients' beliefs about their medicines will be measured by a validated Norwegian translation of the BMQ

Other outcomes

  1. Number of reported Medication-Related Problems in the intervention arm

    Time frame: During the intervention

    The pharmacist carrying out the intervention will report all discovered Medication-Related Problems

  2. Patients' evaluation of "Medisinstart"

    Time frame: 7 weeks after dispensing the new medicine

    Patients' in the intervention arm will evaluate the service by answering a questionnaire

  3. Pharmacists' evaluation of patient benefit

    Time frame: 7 months after start of the study

    Pharmacists performing the service will answer the following question (translated from Norwegian): "You have currently performed "Medisinstart" with at least 5 patients. Do you regard it to be beneficial for the patients?"

  4. Pharmacy costs by performing the service

    Time frame: 1 year after study start

    Pharmacies will report the COSTs for carrying out the service

Sponsors and collaborators

Lead sponsor

Apokus AS

Other

Collaborators

  • Norwegian Pharmacy Association

Registry information

Official study title

Effectiveness of "Medisinstart" - an Open Randomized Controlled Trial of a Newly Developed Pharmacy Service

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Oct 10, 2014
Registry last updated
Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.