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Tailored Intervention to Improve Medication Adherence in Patients With Hypertension

This study is currently recruiting participants.
Verified February 2013 by Odense University Hospital
Sponsor:
Collaborator:
University of Southern Denmark
Information provided by (Responsible Party):
Ulla Hedegaard, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01742923
First received: December 4, 2012
Last updated: February 1, 2013
Last verified: February 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pharmacist Intervention Programme in Secondary Care to Improve Medication Adherence in Patients With Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Reduction in systolic and diastolic blood pressure [ Time Frame: One year from inclusion ] [ Designated as safety issue: No ]
  • Composite endpoint (stroke, myocardial infarction or cardiovascular death) [ Time Frame: One year from inclusion ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: December 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: December 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742923

Contacts
Contact: Ulla Hedegaard, MSc (pharm) +45 65504198 uhedegaard@health.sdu.dk

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

No publications provided

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
Study First Received: December 4, 2012
Last Updated: February 1, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013