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Effectiveness of "Medisinstart"

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ClinicalTrials.gov Identifier: NCT02261402
Recruitment Status : Completed
First Posted : October 10, 2014
Last Update Posted : July 20, 2021
Sponsor:
Collaborator:
Norwegian Pharmacy Association
Information provided by (Responsible Party):
Apokus AS

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.


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Other: Medisinstart Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effectiveness of "Medisinstart" - an Open Randomized Controlled Trial of a Newly Developed Pharmacy Service
Study Start Date : October 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: Medisinstart
Patients in this arm will receive the service; Medisinstart
Other: 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.

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02261402


Locations
Show Show 67 study locations
Sponsors and Collaborators
Apokus AS
Norwegian Pharmacy Association
Investigators
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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)
Publications:
Sabate E. (Ed.) (2003), Adherence to Long-Term Therapies: Evidence for Action. Geneva, Switzerland: World Health Organization

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Responsible Party: Apokus AS
ClinicalTrials.gov Identifier: NCT02261402    
Other Study ID Numbers: Apokus-001
First Posted: October 10, 2014    Key Record Dates
Last Update Posted: July 20, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Apokus AS:
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
Additional relevant MeSH terms:
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Cardiovascular Diseases