Effectiveness of "Medisinstart"
1 other identifier
interventional
1,480
1 country
67
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cardiovascular-diseases
Started Oct 2014
Typical duration for not_applicable cardiovascular-diseases
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 7, 2014
CompletedFirst Posted
Study publicly available on registry
October 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJuly 20, 2021
July 1, 2021
1.2 years
October 7, 2014
July 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
7 weeks after dispensing the new medicine
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
18 weeks after dispensing the new medicine
Secondary Outcomes (7)
Self reported adherence at 7 weeks
7 weeks after dispensing the new medicine
Adherence by Medication Possession Ratio (MPR) at 18 weeks
18 weeks after dispensing the new medicine
Patients' beliefs about their medicines by Beliefs about Medicines Questionnaire (BMQ) at inclusion
At inclusion
Self reported adherence at 18 weeks
18 weeks after dispensing the new medicine
Adherence by Medication Possession Ratio (MPR) at 1 year
1 year after dispensing the new medicine
- +2 more secondary outcomes
Other Outcomes (4)
Number of reported Medication-Related Problems in the intervention arm
During the intervention
Patients' evaluation of "Medisinstart"
7 weeks after dispensing the new medicine
Pharmacists' evaluation of patient benefit
7 months after start of the study
- +1 more other outcomes
Study Arms (2)
Medisinstart
EXPERIMENTALPatients in this arm will receive the service; Medisinstart
Current Practice
NO 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.
Interventions
"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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Prior use (within the last 3 years) of the drug in question independent of strength, dose and formulation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Apokus ASlead
- Norwegian Pharmacy Associationcollaborator
Study Sites (67)
Apotek 1 Alta
Alta, Norway
Apotek 1 Andselv
Andselv, Norway
Boots apotek Harebakken
Arendal, Norway
Sykehusapoteket Arendal
Arendal, Norway
Boots apotek Moa
Ålesund, Norway
Vitusapotek Raumnes
Årnes, Norway
Vitusapotek Årnes
Årnes, 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
Apotek 1 Kvadrat
Sandnes, Norway
Vitusapotek Ganddal
Sandnes, Norway
Vitusapotek Syv Søstre
Sandnessjøen, 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
Apotek 1 Ski Amfi
Ski, Norway
Sykehusapoteket Skien
Skien, 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
Gausdal apotek
Østre Gausdal, Norway
Related Publications (10)
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.
PMID: 15175485BACKGROUNDBoyd 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.
PMID: 24289059BACKGROUNDClifford 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.
PMID: 17004019BACKGROUNDElliott 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.
PMID: 17557211BACKGROUNDHaynes 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.
PMID: 12076376BACKGROUNDHorne 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.
PMID: 10661603BACKGROUNDHov 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.
PMID: 22353834BACKGROUNDMorisky 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.
PMID: 18453793BACKGROUNDRuths S, Viktil KK, Blix HS. [Classification of drug-related problems]. Tidsskr Nor Laegeforen. 2007 Nov 29;127(23):3073-6. Norwegian.
PMID: 18049498BACKGROUNDSabate E. (Ed.) (2003), Adherence to Long-Term Therapies: Evidence for Action. Geneva, Switzerland: World Health Organization
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Karine W Ruud, PhD
Apokus AS
- STUDY DIRECTOR
Sara Bremer, PhD
Apokus AS
- STUDY DIRECTOR
Ragnar Hovland, PhD
Photocure ASA (current affiliation), Apokus AS (until Dec. 2016)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2014
First Posted
October 10, 2014
Study Start
October 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2017
Last Updated
July 20, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share