Effectiveness of "Medisinstart"

NCT ID: NCT02261402

Last Updated: 2021-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-12-31

Brief Summary

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"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.

Detailed Description

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Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Medisinstart

Patients in this arm will receive the service; Medisinstart

Group Type EXPERIMENTAL

Medisinstart

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian Pharmacy Association

OTHER

Sponsor Role collaborator

Apokus AS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karine W Ruud, PhD

Role: STUDY_DIRECTOR

Apokus AS

Sara Bremer, PhD

Role: STUDY_DIRECTOR

Apokus AS

Ragnar Hovland, PhD

Role: STUDY_DIRECTOR

Photocure ASA (current affiliation), Apokus AS (until Dec. 2016)

Locations

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Apotek 1 Alta

Alta, , Norway

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Apotek 1 Andselv

Andselv, , Norway

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Boots apotek Harebakken

Arendal, , Norway

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Sykehusapoteket Arendal

Arendal, , Norway

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Boots apotek Moa

Ålesund, , Norway

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Vitusapotek Raumnes

Årnes, , Norway

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Vitusapotek Årnes

Årnes, , Norway

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Apotek 1 Horisont

Bergen, , Norway

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Boots apotek Bryggen

Bergen, , Norway

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Sjukehusapoteket i Bergen

Bergen, , Norway

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Sykehusapoteket i Bodø

Bodø, , Norway

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Apotek 1 Brandbu

Brandbu, , Norway

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Apotek 1 Bømlo

Bremnes, , Norway

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Apotek 1 Åssiden

Drammen, , Norway

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Sykehusapoteket Drammen

Drammen, , Norway

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Boots apotek Elverum

Elverum, , Norway

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Sykehusapoteket Elverum

Elverum, , Norway

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Boots apotek Flisa

Flisa, , Norway

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Apotek 1 Helsehuset Fredrikstad

Fredrikstad, , Norway

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Sjukehusapoteket i Førde

Førde, , Norway

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Boots apotek Hamar

Hamar, , Norway

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Sjukehusapoteket i Haugesund

Haugesund, , Norway

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Apotek 1 Lerka

Kleppe, , Norway

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Apotek 1 Kopervik

Kopervik, , Norway

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Vitusapotek Sørlandssenteret

Kristiansand, , Norway

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Boots apotek Larvik

Larvik, , Norway

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Apotek 1 Lofotsenteret

Leknes, , Norway

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Apotek 1 Malvik

Malvik, , Norway

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Apotek 1 Mandal

Mandal, , Norway

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Ditt apotek Maura

Maura, , Norway

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Ditt apotek Meyer

Mo i Rana, , Norway

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Ditt apotek Ytteren

Mo i Rana, , Norway

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Apotek 1 Sjøsiden

Mosjøen, , Norway

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Vitusapotek Varnaveien Moss

Moss, , Norway

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Apotek 1 Morenen

Mysen, , Norway

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Vitusapotek Nesbru

Nesbru, , Norway

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Apotek 1 St. Hanshaugen senter

Oslo, , Norway

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Boots apotek Bogstadveien

Oslo, , Norway

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Boots apotek Skøyen

Oslo, , Norway

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Boots apotek Solli

Oslo, , Norway

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Diakonhjemmets sykehusapotek

Oslo, , Norway

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Lovisenberg sykehusapotek

Oslo, , Norway

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Sykehusapoteket Oslo, Ullevål

Oslo, , Norway

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Vitusapotek Storo

Oslo, , Norway

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Vitusapotek Raufoss

Raufoss, , Norway

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Apotek 1 Kvadrat

Sandnes, , Norway

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Vitusapotek Ganddal

Sandnes, , Norway

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Vitusapotek Syv Søstre

Sandnessjøen, , Norway

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Apotek 1 Sandvika Storsenter

Sandvika, , Norway

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Sykehusapoteket Bærum

Sandvika, , Norway

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Boots apotek Lande

Sarpsborg, , Norway

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Boots apotek Saupstad

Saupstad, , Norway

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Vitusapotek Selbak

Sellebakk, , Norway

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Apotek 1 Ski Amfi

Ski, , Norway

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Sykehusapoteket Skien

Skien, , Norway

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Apotek 1 Hjorten Stavanger

Stavanger, , Norway

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Sjukehusapoteket i Stavanger

Stavanger, , Norway

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Vitusapotek Løven Stavanger

Stavanger, , Norway

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Vitusapotek Medisinsk senter - Steinkjer

Steinkjer, , Norway

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Sykehusapoteket Lørenskog

Strømmen, , Norway

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Vitusapotek Strømmen storsenter

Strømmen, , Norway

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Vitusapotek K1 Tromsø

Tromsø, , Norway

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Boots apotek Nordre

Trondheim, , Norway

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Vitusapotek Solsiden

Trondheim, , Norway

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Sykehusapoteket Tønsberg

Tønsberg, , Norway

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Vitusapotek Innherred

Verdal, , Norway

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Gausdal apotek

Østre Gausdal, , Norway

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Countries

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Norway

References

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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.

Reference Type BACKGROUND
PMID: 15175485 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24289059 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17004019 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17557211 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12076376 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10661603 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22353834 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18453793 (View on PubMed)

Ruths S, Viktil KK, Blix HS. [Classification of drug-related problems]. Tidsskr Nor Laegeforen. 2007 Nov 29;127(23):3073-6. Norwegian.

Reference Type BACKGROUND
PMID: 18049498 (View on PubMed)

Sabate E. (Ed.) (2003), Adherence to Long-Term Therapies: Evidence for Action. Geneva, Switzerland: World Health Organization

Reference Type BACKGROUND

Other Identifiers

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Apokus-001

Identifier Type: -

Identifier Source: org_study_id

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