<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02261402</url>
  </required_header>
  <id_info>
    <org_study_id>Apokus-001</org_study_id>
    <nct_id>NCT02261402</nct_id>
  </id_info>
  <brief_title>Effectiveness of &quot;Medisinstart&quot;</brief_title>
  <official_title>Effectiveness of &quot;Medisinstart&quot; - an Open Randomized Controlled Trial of a Newly Developed Pharmacy Service</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Apokus AS</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Norwegian Pharmacy Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Apokus AS</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      &quot;Medisinstart&quot; is a new service developed for use in Norwegian pharmacies. It is intended for&#xD;
      patients that are about to start a new medicine for a chronic or long-term condition. It is&#xD;
      based on research showing that problems with newly prescribed medicines appear rapidly and&#xD;
      that a significant portion of patients quickly becomes non-adherent. The service consists of&#xD;
      two follow-up consultations with a pharmacist. The first at 1-2 weeks and the second at 3-5&#xD;
      weeks after start of the new medicine.&#xD;
&#xD;
      The main purpose of this study is to investigate whether &quot;Medisinstart&quot; increases patients'&#xD;
      adherence to the prescribed medication. Patients' beliefs about their medicines and their&#xD;
      motivation for adherence will also be examined. The study also aims at revealing if&#xD;
      &quot;Medisinstart&quot; has additional benefits for the patient, the society and the pharmacies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence by Morisky 8-item Medication Adherence Scale (MMAS-8) at 7 weeks</measure>
    <time_frame>7 weeks after dispensing the new medicine</time_frame>
    <description>Adherence will be measured by a validated Norwegian translation of the MMAS-8</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence by Morisky 8-item Medication Adherence Scale (MMAS-8) at 18 weeks</measure>
    <time_frame>18 weeks after dispensing the new medicine</time_frame>
    <description>Adherence will be measured by a validated Norwegian translation of the MMAS-8</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self reported adherence at 7 weeks</measure>
    <time_frame>7 weeks after dispensing the new medicine</time_frame>
    <description>Adherence will be measured by a Norwegian translation of the question: &quot;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?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence by Medication Possession Ratio (MPR) at 18 weeks</measure>
    <time_frame>18 weeks after dispensing the new medicine</time_frame>
    <description>Adherence by MPR will be calculated from data collected from the Norwegian Prescription Database</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients' beliefs about their medicines by Beliefs about Medicines Questionnaire (BMQ) at inclusion</measure>
    <time_frame>At inclusion</time_frame>
    <description>Patients' beliefs about their medicines will be measured by a validated Norwegian translation of the BMQ</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self reported adherence at 18 weeks</measure>
    <time_frame>18 weeks after dispensing the new medicine</time_frame>
    <description>Adherence will be measured by a Norwegian translation of the question: &quot;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?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence by Medication Possession Ratio (MPR) at 1 year</measure>
    <time_frame>1 year after dispensing the new medicine</time_frame>
    <description>Adherence by MPR will be calculated from data collected from the Norwegian Prescription Database</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients' beliefs about their medicines by Beliefs about Medicines Questionnaire (BMQ) at 7 weeks</measure>
    <time_frame>7 weeks after dispensing the new medicine</time_frame>
    <description>Patients' beliefs about their medicines will be measured by a validated Norwegian translation of the BMQ</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients' beliefs about their medicines by Beliefs about Medicines Questionnaire (BMQ) at 18 weeks</measure>
    <time_frame>18 weeks after dispensing the new medicine</time_frame>
    <description>Patients' beliefs about their medicines will be measured by a validated Norwegian translation of the BMQ</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of reported Medication-Related Problems in the intervention arm</measure>
    <time_frame>During the intervention</time_frame>
    <description>The pharmacist carrying out the intervention will report all discovered Medication-Related Problems</description>
  </other_outcome>
  <other_outcome>
    <measure>Patients' evaluation of &quot;Medisinstart&quot;</measure>
    <time_frame>7 weeks after dispensing the new medicine</time_frame>
    <description>Patients' in the intervention arm will evaluate the service by answering a questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Pharmacists' evaluation of patient benefit</measure>
    <time_frame>7 months after start of the study</time_frame>
    <description>Pharmacists performing the service will answer the following question (translated from Norwegian): &quot;You have currently performed &quot;Medisinstart&quot; with at least 5 patients. Do you regard it to be beneficial for the patients?&quot;</description>
  </other_outcome>
  <other_outcome>
    <measure>Pharmacy costs by performing the service</measure>
    <time_frame>1 year after study start</time_frame>
    <description>Pharmacies will report the COSTs for carrying out the service</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1480</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>Medisinstart</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm will receive the service; Medisinstart</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Current Practice</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Medisinstart</intervention_name>
    <description>&quot;Medisinstart&quot; 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.</description>
    <arm_group_label>Medisinstart</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        First time prescription for a drug belonging to one of the following groups (ATC-code):&#xD;
&#xD;
          -  Dabigatran etexilate (B01AE07)&#xD;
&#xD;
          -  Rivaroxaban (B01AF01)&#xD;
&#xD;
          -  Apixaban (B01AF02)&#xD;
&#xD;
          -  Beta blocking agents (C07)&#xD;
&#xD;
          -  Calcium channel blockers (C08)&#xD;
&#xD;
          -  Agents acting on the renin-angiotensin system (C09)&#xD;
&#xD;
          -  HMG CoA reductase inhibitors (statins) (C10AA)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior use (within the last 3 years) of the drug in question independent of strength,&#xD;
             dose and formulation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karine W Ruud, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Apokus AS</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sara Bremer, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Apokus AS</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ragnar Hovland, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Photocure ASA (current affiliation), Apokus AS (until Dec. 2016)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Apotek 1 Alta</name>
      <address>
        <city>Alta</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apotek 1 Andselv</name>
      <address>
        <city>Andselv</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boots apotek Harebakken</name>
      <address>
        <city>Arendal</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sykehusapoteket Arendal</name>
      <address>
        <city>Arendal</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apotek 1 Horisont</name>
      <address>
        <city>Bergen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boots apotek Bryggen</name>
      <address>
        <city>Bergen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sjukehusapoteket i Bergen</name>
      <address>
        <city>Bergen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sykehusapoteket i Bodø</name>
      <address>
        <city>Bodø</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apotek 1 Brandbu</name>
      <address>
        <city>Brandbu</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apotek 1 Bømlo</name>
      <address>
        <city>Bremnes</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apotek 1 Åssiden</name>
      <address>
        <city>Drammen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sykehusapoteket Drammen</name>
      <address>
        <city>Drammen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boots apotek Elverum</name>
      <address>
        <city>Elverum</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sykehusapoteket Elverum</name>
      <address>
        <city>Elverum</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boots apotek Flisa</name>
      <address>
        <city>Flisa</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apotek 1 Helsehuset Fredrikstad</name>
      <address>
        <city>Fredrikstad</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sjukehusapoteket i Førde</name>
      <address>
        <city>Førde</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boots apotek Hamar</name>
      <address>
        <city>Hamar</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sjukehusapoteket i Haugesund</name>
      <address>
        <city>Haugesund</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apotek 1 Lerka</name>
      <address>
        <city>Kleppe</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apotek 1 Kopervik</name>
      <address>
        <city>Kopervik</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitusapotek Sørlandssenteret</name>
      <address>
        <city>Kristiansand</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boots apotek Larvik</name>
      <address>
        <city>Larvik</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apotek 1 Lofotsenteret</name>
      <address>
        <city>Leknes</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apotek 1 Malvik</name>
      <address>
        <city>Malvik</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apotek 1 Mandal</name>
      <address>
        <city>Mandal</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ditt apotek Maura</name>
      <address>
        <city>Maura</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ditt apotek Meyer</name>
      <address>
        <city>Mo i Rana</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ditt apotek Ytteren</name>
      <address>
        <city>Mo i Rana</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apotek 1 Sjøsiden</name>
      <address>
        <city>Mosjøen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitusapotek Varnaveien Moss</name>
      <address>
        <city>Moss</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apotek 1 Morenen</name>
      <address>
        <city>Mysen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitusapotek Nesbru</name>
      <address>
        <city>Nesbru</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apotek 1 St. Hanshaugen senter</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boots apotek Bogstadveien</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boots apotek Skøyen</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boots apotek Solli</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diakonhjemmets sykehusapotek</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lovisenberg sykehusapotek</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sykehusapoteket Oslo, Ullevål</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitusapotek Storo</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitusapotek Raufoss</name>
      <address>
        <city>Raufoss</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitusapotek Syv Søstre</name>
      <address>
        <city>Sandnessjøen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apotek 1 Kvadrat</name>
      <address>
        <city>Sandnes</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitusapotek Ganddal</name>
      <address>
        <city>Sandnes</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apotek 1 Sandvika Storsenter</name>
      <address>
        <city>Sandvika</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sykehusapoteket Bærum</name>
      <address>
        <city>Sandvika</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boots apotek Lande</name>
      <address>
        <city>Sarpsborg</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boots apotek Saupstad</name>
      <address>
        <city>Saupstad</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitusapotek Selbak</name>
      <address>
        <city>Sellebakk</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sykehusapoteket Skien</name>
      <address>
        <city>Skien</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apotek 1 Ski Amfi</name>
      <address>
        <city>Ski</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apotek 1 Hjorten Stavanger</name>
      <address>
        <city>Stavanger</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sjukehusapoteket i Stavanger</name>
      <address>
        <city>Stavanger</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitusapotek Løven Stavanger</name>
      <address>
        <city>Stavanger</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitusapotek Medisinsk senter - Steinkjer</name>
      <address>
        <city>Steinkjer</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sykehusapoteket Lørenskog</name>
      <address>
        <city>Strømmen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitusapotek Strømmen storsenter</name>
      <address>
        <city>Strømmen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitusapotek K1 Tromsø</name>
      <address>
        <city>Tromsø</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boots apotek Nordre</name>
      <address>
        <city>Trondheim</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitusapotek Solsiden</name>
      <address>
        <city>Trondheim</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sykehusapoteket Tønsberg</name>
      <address>
        <city>Tønsberg</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitusapotek Innherred</name>
      <address>
        <city>Verdal</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boots apotek Moa</name>
      <address>
        <city>Ålesund</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitusapotek Raumnes</name>
      <address>
        <city>Årnes</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitusapotek Årnes</name>
      <address>
        <city>Årnes</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gausdal apotek</name>
      <address>
        <city>Østre Gausdal</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>15175485</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24289059</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17004019</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17557211</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>12076376</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>10661603</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22353834</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>18453793</PMID>
  </reference>
  <reference>
    <citation>Ruths S, Viktil KK, Blix HS. [Classification of drug-related problems]. Tidsskr Nor Laegeforen. 2007 Nov 29;127(23):3073-6. Norwegian.</citation>
    <PMID>18049498</PMID>
  </reference>
  <reference>
    <citation>Sabate E. (Ed.) (2003), Adherence to Long-Term Therapies: Evidence for Action. Geneva, Switzerland: World Health Organization</citation>
  </reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>October 7, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>July 19, 2021</last_update_submitted>
  <last_update_submitted_qc>July 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adherence</keyword>
  <keyword>Morisky Medication Adherence Scale</keyword>
  <keyword>Beliefs about Medicines Questionnaire</keyword>
  <keyword>Medication Possession Ratio</keyword>
  <keyword>Medication-Related Problems</keyword>
  <keyword>Pharmacist</keyword>
  <keyword>Pharmacist Intervention</keyword>
  <keyword>Pharmacy</keyword>
  <keyword>Pharmacy Service</keyword>
  <keyword>Pharmacy Practice</keyword>
  <keyword>Hypertension</keyword>
  <keyword>Antihypertensive Agents</keyword>
  <keyword>Anticoagulants</keyword>
  <keyword>Statins</keyword>
  <keyword>Dyslipidemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02261402
org study id: Apokus-001
nct id: NCT02261402
lead sponsor: 
collaborator: 
has dmc: No
"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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Adherence by Morisky 8-item Medication Adherence Scale (MMAS-8) at 7 weeks
time frame: 7 weeks after dispensing the new medicine
description: Adherence will be measured by a validated Norwegian translation of the MMAS-8
measure: Adherence by Morisky 8-item Medication Adherence Scale (MMAS-8) at 18 weeks
time frame: 18 weeks after dispensing the new medicine
description: Adherence will be measured by a validated Norwegian translation of the MMAS-8
measure: Self reported adherence at 7 weeks
time frame: 7 weeks after dispensing the new medicine
description: 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?"
measure: Adherence by Medication Possession Ratio (MPR) at 18 weeks
time frame: 18 weeks after dispensing the new medicine
description: Adherence by MPR will be calculated from data collected from the Norwegian Prescription Database
measure: Patients' beliefs about their medicines by Beliefs about Medicines Questionnaire (BMQ) at inclusion
time frame: At inclusion
description: Patients' beliefs about their medicines will be measured by a validated Norwegian translation of the BMQ
measure: Self reported adherence at 18 weeks
time frame: 18 weeks after dispensing the new medicine
description: 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?"
measure: Adherence by Medication Possession Ratio (MPR) at 1 year
time frame: 1 year after dispensing the new medicine
description: Adherence by MPR will be calculated from data collected from the Norwegian Prescription Database
measure: Patients' beliefs about their medicines by Beliefs about Medicines Questionnaire (BMQ) at 7 weeks
time frame: 7 weeks after dispensing the new medicine
description: Patients' beliefs about their medicines will be measured by a validated Norwegian translation of the BMQ
measure: Patients' beliefs about their medicines by Beliefs about Medicines Questionnaire (BMQ) at 18 weeks
time frame: 18 weeks after dispensing the new medicine
description: Patients' beliefs about their medicines will be measured by a validated Norwegian translation of the BMQ
measure: Number of reported Medication-Related Problems in the intervention arm
time frame: During the intervention
description: The pharmacist carrying out the intervention will report all discovered Medication-Related Problems
measure: Patients' evaluation of "Medisinstart"
time frame: 7 weeks after dispensing the new medicine
description: Patients' in the intervention arm will evaluate the service by answering a questionnaire
measure: Pharmacists' evaluation of patient benefit
time frame: 7 months after start of the study
description: 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?"
measure: Pharmacy costs by performing the service
time frame: 1 year after study start
description: Pharmacies will report the COSTs for carrying out the service
arm group label: Medisinstart
arm group type: Experimental
description: Patients in this arm will receive the service; Medisinstart
arm group label: Current Practice
arm group type: No Intervention
description: 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.
intervention type: Other
intervention name: Medisinstart
description: "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.
arm group label: Medisinstart
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Karine W Ruud, PhD
role: Study Director
affiliation: Apokus AS
last name: Sara Bremer, PhD
role: Study Director
affiliation: Apokus AS
last name: Ragnar Hovland, PhD
role: Study Director
affiliation: Photocure ASA (current affiliation), Apokus AS (until Dec. 2016)
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country: Norway
citation: 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: 15175485
citation: 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.
PMID: 24289059
citation: 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.
PMID: 17004019
citation: 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.
PMID: 17557211
citation: 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.
PMID: 12076376
citation: 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.
PMID: 10661603
citation: 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.
PMID: 22353834
citation: 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.
PMID: 18453793
citation: Ruths S, Viktil KK, Blix HS. [Classification of drug-related problems]. Tidsskr Nor Laegeforen. 2007 Nov 29;127(23):3073-6. Norwegian.
PMID: 18049498
citation: Sabate E. (Ed.) (2003), Adherence to Long-Term Therapies: Evidence for Action. Geneva, Switzerland: World Health Organization
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
sharing ipd: No