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CompletedNCT02261402Updated Jul 20, 2021

Effectiveness of "Medisinstart"

An interventional study of Medisinstart in Cardiovascular Diseases, sponsored by Apokus AS. Completed at 67 sites in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-20.

Sponsored by Apokus AS · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
1,480
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cardiovascular Diseases

Keywords

  • Adherence
  • Morisky Medication Adherence Scale
  • Beliefs about Medicines Questionnaire
  • Medication Possession Ratio
  • Medication-Related Problems
  • Pharmacist
  • Pharmacist Intervention
  • Pharmacy
  • Pharmacy Service
  • Pharmacy Practice
  • Hypertension
  • Antihypertensive Agents
  • Anticoagulants
  • Statins
  • Dyslipidemia
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 1,480 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Apokus AS is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Prior use (within the last 3 years) of the drug in question independent of strength, dose and formulation
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,480 participants (actual)

Study arms

  • Experimental
    Medisinstart

    Patients in this arm will receive the service; Medisinstart

    Other: Medisinstart

  • No intervention
    Current Practice

    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.

Interventions

  • OtherMedisinstart

    "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.

06

What researchers measure

Primary outcomes

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

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

    Time frame: 7 weeks after dispensing the new medicine

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

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

    Time frame: 18 weeks after dispensing the new medicine

Secondary outcomes

  1. Self reported adherence at 7 weeks

    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?"

    Time frame: 7 weeks after dispensing the new medicine

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

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

    Time frame: 18 weeks after dispensing the new medicine

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

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

    Time frame: At inclusion

  4. Self reported adherence at 18 weeks

    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?"

    Time frame: 18 weeks after dispensing the new medicine

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

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

    Time frame: 1 year after dispensing the new medicine

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

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

    Time frame: 7 weeks after dispensing the new medicine

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

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

    Time frame: 18 weeks after dispensing the new medicine

Other outcomes

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

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

    Time frame: During the intervention

  2. Patients' evaluation of "Medisinstart"

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

    Time frame: 7 weeks after dispensing the new medicine

  3. Pharmacists' evaluation of patient benefit

    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?"

    Time frame: 7 months after start of the study

  4. Pharmacy costs by performing the service

    Pharmacies will report the COSTs for carrying out the service

    Time frame: 1 year after study start

07

Study locations

67 sites
  • Apotek 1 Alta
    Alta, Norway
  • Apotek 1 Andselv
    Andselv, Norway
  • Boots apotek Harebakken
    Arendal, Norway
  • Sykehusapoteket Arendal
    Arendal, Norway
  • Apotek 1 Horisont
    Bergen, Norway
  • Boots apotek Bryggen
    Bergen, Norway
  • Sjukehusapoteket i Bergen
    Bergen, Norway
  • Sykehusapoteket i Bodø
    Bodø, Norway
  • Apotek 1 Brandbu
    Brandbu, Norway
  • Apotek 1 Bømlo
    Bremnes, Norway
  • Apotek 1 Åssiden
    Drammen, Norway
  • Sykehusapoteket Drammen
    Drammen, Norway
  • Boots apotek Elverum
    Elverum, Norway
  • Sykehusapoteket Elverum
    Elverum, Norway
  • Boots apotek Flisa
    Flisa, Norway
  • Apotek 1 Helsehuset Fredrikstad
    Fredrikstad, Norway
  • Sjukehusapoteket i Førde
    Førde, Norway
  • Boots apotek Hamar
    Hamar, Norway
  • Sjukehusapoteket i Haugesund
    Haugesund, Norway
  • Apotek 1 Lerka
    Kleppe, Norway
  • Apotek 1 Kopervik
    Kopervik, Norway
  • Vitusapotek Sørlandssenteret
    Kristiansand, Norway
  • Boots apotek Larvik
    Larvik, Norway
  • Apotek 1 Lofotsenteret
    Leknes, Norway
  • Apotek 1 Malvik
    Malvik, Norway
  • Apotek 1 Mandal
    Mandal, Norway
  • Ditt apotek Maura
    Maura, Norway
  • Ditt apotek Meyer
    Mo i Rana, Norway
  • Ditt apotek Ytteren
    Mo i Rana, Norway
  • Apotek 1 Sjøsiden
    Mosjøen, Norway
  • Vitusapotek Varnaveien Moss
    Moss, Norway
  • Apotek 1 Morenen
    Mysen, Norway
  • Vitusapotek Nesbru
    Nesbru, Norway
  • Apotek 1 St. Hanshaugen senter
    Oslo, Norway
  • Boots apotek Bogstadveien
    Oslo, Norway
  • Boots apotek Skøyen
    Oslo, Norway
  • Boots apotek Solli
    Oslo, Norway
  • Diakonhjemmets sykehusapotek
    Oslo, Norway
  • Lovisenberg sykehusapotek
    Oslo, Norway
  • Sykehusapoteket Oslo, Ullevål
    Oslo, Norway
  • Vitusapotek Storo
    Oslo, Norway
  • Vitusapotek Raufoss
    Raufoss, Norway
  • Vitusapotek Syv Søstre
    Sandnessjøen, Norway
  • Apotek 1 Kvadrat
    Sandnes, Norway
  • Vitusapotek Ganddal
    Sandnes, Norway
  • Apotek 1 Sandvika Storsenter
    Sandvika, Norway
  • Sykehusapoteket Bærum
    Sandvika, Norway
  • Boots apotek Lande
    Sarpsborg, Norway
  • Boots apotek Saupstad
    Saupstad, Norway
  • Vitusapotek Selbak
    Sellebakk, Norway
  • Sykehusapoteket Skien
    Skien, Norway
  • Apotek 1 Ski Amfi
    Ski, Norway
  • Apotek 1 Hjorten Stavanger
    Stavanger, Norway
  • Sjukehusapoteket i Stavanger
    Stavanger, Norway
  • Vitusapotek Løven Stavanger
    Stavanger, Norway
  • Vitusapotek Medisinsk senter - Steinkjer
    Steinkjer, Norway
  • Sykehusapoteket Lørenskog
    Strømmen, Norway
  • Vitusapotek Strømmen storsenter
    Strømmen, Norway
  • Vitusapotek K1 Tromsø
    Tromsø, Norway
  • Boots apotek Nordre
    Trondheim, Norway
  • Vitusapotek Solsiden
    Trondheim, Norway
  • Sykehusapoteket Tønsberg
    Tønsberg, Norway
  • Vitusapotek Innherred
    Verdal, Norway
  • Boots apotek Moa
    Ålesund, Norway
  • Vitusapotek Raumnes
    Årnes, Norway
  • Vitusapotek Årnes
    Årnes, Norway
  • Gausdal apotek
    Østre Gausdal, Norway
08

References and documents

Publications

  • Barber N, Parsons J, Clifford S, Darracott R, Horne R. Patients' problems with new medication for chronic conditions. Qual Saf Health Care. 2004 Jun;13(3):172-5. doi: 10.1136/qhc.13.3.172. PubMed 15175485 ↗
  • Boyd M, Waring J, Barber N, Mehta R, Chuter A, Avery AJ, Salema NE, Davies J, Latif A, Tanajewski L, Elliott RA. Protocol for the New Medicine Service Study: a randomized controlled trial and economic evaluation with qualitative appraisal comparing the effectiveness and cost effectiveness of the New Medicine Service in community pharmacies in England. Trials. 2013 Dec 1;14:411. doi: 10.1186/1745-6215-14-411. PubMed 24289059 ↗
  • Clifford S, Barber N, Elliott R, Hartley E, Horne R. Patient-centred advice is effective in improving adherence to medicines. Pharm World Sci. 2006 Jun;28(3):165-70. doi: 10.1007/s11096-006-9026-6. Epub 2006 Sep 27. PubMed 17004019 ↗
  • Elliott RA, Barber N, Clifford S, Horne R, Hartley E. The cost effectiveness of a telephone-based pharmacy advisory service to improve adherence to newly prescribed medicines. Pharm World Sci. 2008 Jan;30(1):17-23. doi: 10.1007/s11096-007-9134-y. Epub 2007 Jun 8. PubMed 17557211 ↗
  • Haynes RB, McDonald H, Garg AX, Montague P. Interventions for helping patients to follow prescriptions for medications. Cochrane Database Syst Rev. 2002;(2):CD000011. doi: 10.1002/14651858.CD000011. PubMed 12076376 ↗
  • Horne R, Weinman J. Patients' beliefs about prescribed medicines and their role in adherence to treatment in chronic physical illness. J Psychosom Res. 1999 Dec;47(6):555-67. doi: 10.1016/s0022-3999(99)00057-4. PubMed 10661603 ↗
  • Hov I, Bjartnes M, Slordal L, Spigset O. [Are drugs taken as prescribed?]. Tidsskr Nor Laegeforen. 2012 Feb 21;132(4):418-22. doi: 10.4045/tidsskr.11.0225. Norwegian. PubMed 22353834 ↗
  • Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich). 2008 May;10(5):348-54. doi: 10.1111/j.1751-7176.2008.07572.x. PubMed 18453793 ↗
  • Ruths S, Viktil KK, Blix HS. [Classification of drug-related problems]. Tidsskr Nor Laegeforen. 2007 Nov 29;127(23):3073-6. Norwegian. PubMed 18049498 ↗
  • Sabate E. (Ed.) (2003), Adherence to Long-Term Therapies: Evidence for Action. Geneva, Switzerland: World Health Organization

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02261402
Lead sponsor
Apokus AS
Collaborators
Norwegian Pharmacy Association
Responsible party
Sponsor
First posted
Oct 10, 2014
Start date
Oct 2014
Primary completion
Dec 2015
Completion
Dec 2017
Last update
Jul 20, 2021

Study contacts

Karine W Ruud, PhD
study director · Apokus AS
Sara Bremer, PhD
study director · Apokus AS
Ragnar Hovland, PhD
study director · Photocure ASA (current affiliation), Apokus AS (until Dec. 2016)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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