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Tailored Intervention to Improve Medication Adherence in Patients With Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01742923
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : November 18, 2015
University of Southern Denmark
Information provided by (Responsible Party):
Ulla Hedegaard, Odense University Hospital

Brief Summary:
Patients with hypertension have an increased risk of stroke and myocardial infarction. However, poor adherence to treatment with antihypertensives and lipid-lowering agents occurs frequently within this patient group. The purpose of this study is to investigate whether a complex tailored intervention in a hospital setting will lead to increased medication adherence and fewer cardiovascular events when compared to a usual care group. Interventions focus on motivational interviewing, medication review and telephone follow up.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Complex tailored intervention Behavioral: Usual care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 532 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pharmacist Intervention Programme in Secondary Care to Improve Medication Adherence in Patients With Hypertension
Study Start Date : December 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Usual care
Usual care
Behavioral: Usual care
Experimental: Complex tailored intervention

The interventions consists of 3 elements:

  1. Medication review with recommendations focused on antihypertensives and statins and adherence to guidelines and patient´s adherence to medications
  2. Consultation with a pharmacist using motivational interviewing techniques
  3. Follow-up telephone calls one month and six months after inclusion
Behavioral: Complex tailored intervention

Primary Outcome Measures :
  1. Percent of patients that are at least 80% adherent (Medication possession rate > 0.8) to antihypertensives and statins [ Time Frame: One year from inclusion ]

Secondary Outcome Measures :
  1. Non-persistence with antihypertensives and statins measured by percent of patients that are not supplied with medications for more than three continuous months [ Time Frame: One year from inclusion ]
  2. Reduction in systolic and diastolic blood pressure [ Time Frame: One year from inclusion ]
  3. Composite endpoint (stroke, myocardial infarction or cardiovascular death) [ Time Frame: One year from inclusion ]

Information from the National Library of Medicine

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

Inclusion Criteria:

Age: 18 years or older

  • Patients receiving ambulatory treatment for hypertension in a hospital setting
  • The patient or a carer usually dispenses the patient's medications
  • Patient lives in the Southern Region of Denmark
  • Written consent

Exclusion Criteria:

  • Lives in a care home or institution
  • Receive dose dispensed medicine from a pharmacy
  • Medicine is dispensed by a nurse in the patient's home
  • Correctional mental health patients

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 identifier (NCT number): NCT01742923

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Odense University Hospital
Odense C, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
University of Southern Denmark
Publications of Results:
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Responsible Party: Ulla Hedegaard, PhD student, MSc (pharm), Odense University Hospital, Odense University Hospital Identifier: NCT01742923    
Other Study ID Numbers: AKF-384
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: November 18, 2015
Last Verified: November 2015
Keywords provided by Ulla Hedegaard, Odense University Hospital:
medication adherence
motivational interviewing
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases