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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	2 August 2021
Main ID:	NCT02261402
Date of registration:	07/10/2014
Prospective Registration:	No
Primary sponsor:	Apokus AS
Public title:	Effectiveness of "Medisinstart"
Scientific title:	Effectiveness of "Medisinstart" - an Open Randomized Controlled Trial of a Newly Developed Pharmacy Service
Date of first enrolment:	October 2014
Target sample size:	1480
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02261402
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
Norway

Contacts

Name:	Ragnar Hovland, PhD
Address:
Telephone:
Email:
Affiliation:	Photocure ASA (current affiliation), Apokus AS (until Dec. 2016)

Name:	Sara Bremer, PhD
Address:
Telephone:
Email:
Affiliation:	Apokus AS

Name:	Karine W Ruud, PhD
Address:
Telephone:
Email:
Affiliation:	Apokus AS

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cardiovascular Diseases

Intervention(s)

Other: Medisinstart

Primary Outcome(s)

Adherence by Morisky 8-item Medication Adherence Scale (MMAS-8) at 7 weeks [Time Frame: 7 weeks after dispensing the new medicine]

Adherence by Morisky 8-item Medication Adherence Scale (MMAS-8) at 18 weeks [Time Frame: 18 weeks after dispensing the new medicine]

Secondary Outcome(s)

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 by Beliefs about Medicines Questionnaire (BMQ) at inclusion [Time Frame: At inclusion]

Adherence by Medication Possession Ratio (MPR) at 1 year [Time Frame: 1 year after dispensing the new medicine]

Self reported adherence at 7 weeks [Time Frame: 7 weeks after dispensing the new medicine]

Adherence by Medication Possession Ratio (MPR) at 18 weeks [Time Frame: 18 weeks after dispensing the new medicine]

Patients' beliefs about their medicines by Beliefs about Medicines Questionnaire (BMQ) at 18 weeks [Time Frame: 18 weeks after dispensing the new medicine]

Self reported adherence at 18 weeks [Time Frame: 18 weeks after dispensing the new medicine]

Secondary ID(s)

Apokus-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Norwegian Pharmacy Association

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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