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Cardiovascular DiseasesNCT02261402

Effectiveness of "Medisinstart"

A study testing Medisinstart in people with Cardiovascular Diseases, run by Apokus AS at 67 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiovascular Diseases
What is being tested?
Medisinstart
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,480 participants
Where
67 sitesNorway
Study dates
Oct 2014to Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

67 sites in 1 country.

67 sites in 1 country

Norway67 sites

  • Boots apotek Moa

    Ålesund

  • Apotek 1 Alta

    Alta

  • Apotek 1 Andselv

    Andselv

  • Boots apotek Harebakken

    Arendal

  • Sykehusapoteket Arendal

    Arendal

  • Vitusapotek Raumnes

    Årnes

  • Vitusapotek Årnes

    Årnes

  • Apotek 1 Horisont

    Bergen

  • Boots apotek Bryggen

    Bergen

  • Sjukehusapoteket i Bergen

    Bergen

  • Sykehusapoteket i Bodø

    Bodø

  • Apotek 1 Brandbu

    Brandbu

  • Apotek 1 Bømlo

    Bremnes

  • Apotek 1 Åssiden

    Drammen

  • Sykehusapoteket Drammen

    Drammen

  • Boots apotek Elverum

    Elverum

  • Sykehusapoteket Elverum

    Elverum

  • Boots apotek Flisa

    Flisa

  • Sjukehusapoteket i Førde

    Førde

  • Apotek 1 Helsehuset Fredrikstad

    Fredrikstad

  • Boots apotek Hamar

    Hamar

  • Sjukehusapoteket i Haugesund

    Haugesund

  • Apotek 1 Lerka

    Kleppe

  • Apotek 1 Kopervik

    Kopervik

  • Vitusapotek Sørlandssenteret

    Kristiansand

  • Boots apotek Larvik

    Larvik

  • Apotek 1 Lofotsenteret

    Leknes

  • Apotek 1 Malvik

    Malvik

  • Apotek 1 Mandal

    Mandal

  • Ditt apotek Maura

    Maura

  • Ditt apotek Meyer

    Mo i Rana

  • Ditt apotek Ytteren

    Mo i Rana

  • Apotek 1 Sjøsiden

    Mosjøen

  • Vitusapotek Varnaveien Moss

    Moss

  • Apotek 1 Morenen

    Mysen

  • Vitusapotek Nesbru

    Nesbru

  • Apotek 1 St. Hanshaugen senter

    Oslo

  • Boots apotek Bogstadveien

    Oslo

  • Boots apotek Skøyen

    Oslo

  • Boots apotek Solli

    Oslo

  • Diakonhjemmets sykehusapotek

    Oslo

  • Lovisenberg sykehusapotek

    Oslo

  • Sykehusapoteket Oslo, Ullevål

    Oslo

  • Vitusapotek Storo

    Oslo

  • Gausdal apotek

    Østre Gausdal

  • Vitusapotek Raufoss

    Raufoss

  • Apotek 1 Kvadrat

    Sandnes

  • Vitusapotek Ganddal

    Sandnes

  • Vitusapotek Syv Søstre

    Sandnessjøen

  • Apotek 1 Sandvika Storsenter

    Sandvika

  • Sykehusapoteket Bærum

    Sandvika

  • Boots apotek Lande

    Sarpsborg

  • Boots apotek Saupstad

    Saupstad

  • Vitusapotek Selbak

    Sellebakk

  • Apotek 1 Ski Amfi

    Ski

  • Sykehusapoteket Skien

    Skien

  • Apotek 1 Hjorten Stavanger

    Stavanger

  • Sjukehusapoteket i Stavanger

    Stavanger

  • Vitusapotek Løven Stavanger

    Stavanger

  • Vitusapotek Medisinsk senter - Steinkjer

    Steinkjer

  • Sykehusapoteket Lørenskog

    Strømmen

  • Vitusapotek Strømmen storsenter

    Strømmen

  • Sykehusapoteket Tønsberg

    Tønsberg

  • Vitusapotek K1 Tromsø

    Tromsø

  • Boots apotek Nordre

    Trondheim

  • Vitusapotek Solsiden

    Trondheim

  • Vitusapotek Innherred

    Verdal

Other trials in Norway

About this study

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

"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.

Being tested
Medisinstart
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
Medical subject headings
Cardiovascular Diseases, Hypertension, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MedisinstartOther

    "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.

Study groups in NCT02261402
Study groupRoleWhat they receive
MedisinstartExperimentalPatients in this arm will receive the service; Medisinstart
Receives: Other: Medisinstart
Current PracticeNo interventionPatients 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: 18 weeks after dispensing the new medicine

Secondary outcomes (7)

  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?"

    Measured: 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

    Measured: 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

    Measured: 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?"

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 18 weeks after dispensing the new medicine

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionDec 2015
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,480 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02261402
Sponsor's protocol ID
Apokus-001
Status last verified
Jul 2021
First submitted
7 Oct 2014
Last updated
20 Jul 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Medisinstart in people with Cardiovascular Diseases, run by Apokus AS at 67 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence by Morisky 8-item Medication Adherence Scale (MMAS-8) at 7 weeks (time frame: 7 weeks after dispensing the new medicine). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02261402, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021; AzTrials last refreshed its copy on 31 Oct 2026.

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