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Tailored Intervention to Improve Medication Adherence in Patients With Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01742923
First Posted: December 6, 2012
Last Update Posted: November 18, 2015
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.
Collaborator:
University of Southern Denmark
Information provided by (Responsible Party):
Ulla Hedegaard, Odense University Hospital
  Purpose
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 Intervention
Hypertension Behavioral: Complex tailored intervention Behavioral: Usual care

Study Type: Interventional
Study Design: 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

Further study details as provided by Ulla Hedegaard, Odense University Hospital:

Primary Outcome Measures:
  • 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:
  • 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 ]
  • Reduction in systolic and diastolic blood pressure [ Time Frame: One year from inclusion ]
  • Composite endpoint (stroke, myocardial infarction or cardiovascular death) [ Time Frame: One year from inclusion ]

Enrollment: 532
Study Start Date: December 2012
Study Completion Date: September 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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): NCT01742923


Locations
Denmark
Odense University Hospital
Odense C, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
University of Southern Denmark
  More Information

Publications:
Responsible Party: Ulla Hedegaard, PhD student, MSc (pharm), Odense University Hospital, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01742923     History of Changes
Other Study ID Numbers: AKF-384
First Submitted: December 4, 2012
First Posted: December 6, 2012
Last Update Posted: November 18, 2015
Last Verified: November 2015

Keywords provided by Ulla Hedegaard, Odense University Hospital:
hypertension
medication adherence
motivational interviewing

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases


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