Pharmacy Implementation Trial: Adherence to Antihypertensive Therapy

This study has been completed.
Sponsor:
Collaborators:
Zorgverzekeraar CZ
Scientific Institute for Dutch Pharmacists, The Netherlands
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00460343
First received: April 4, 2007
Last updated: July 9, 2008
Last verified: July 2008
  Purpose

The purpose of this study is to determine the effectiveness of maximal support of community pharmacies to implement a pharmaceutical care model for establishing and - if necessary - improving adherence to antihypertensive medication in patients with medication-resistant hypertension.


Condition Intervention
Hypertension
Other: extensive implementation programme
Other: control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Implementation of a Pharmacy-Intervention to Establish and if Necessary Improve Adherence to Antihypertensive Therapy. A Cluster Randomized Trial.

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • the number of patients included for intervention [ Time Frame: 9 months after start of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • improvement of systolic blood pressure [ Time Frame: 2 and 5 months after inclusion ] [ Designated as safety issue: No ]
  • treatment escalation of patients after inclusion into the study [ Time Frame: 5 months after inclusion ] [ Designated as safety issue: No ]
  • the percentage of GP's in PTAM that cooperates in the intervention [ Time Frame: 9 months after start of the study ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: April 2007
Study Completion Date: June 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: max Other: extensive implementation programme
experimental pharmacists follow an extensive implementation programme. They attend two interactive half a day educational meetings tailored to individual needs: one at start of the intervention, and one in May or September 2007. Special attention is given to multiprofessional cooperation with general practitioners and nurse practitioners. Additionally, guided by their own project planning pharmacists receive three or more telephone calls, both as a reminder, feedback, and in order to investigate whether they need any more help.
Active Comparator: min Other: control
pharmacists only receive a written manual with instructions to implement the patient compliance intervention.

Detailed Description:

Cardiovascular disease is the main cause of death in large parts of the world. Hypertension is an important risk factor for cardiovascular disease. Although hypertension treatment has improved in the last decade, the effectiveness of antihypertensive therapy still needs attention. Adherence to medication appears to play an important role in that.

Pharmacists can support the general practitioners in their efforts to optimize antihypertensive therapy, by establishing adherence to medication of patients with hypertension in spite of the use of one or more antihypertensive drugs. This is performed with the electronic Medication Event Monitoring System (MEMS®). Registered adherence and accompanying blood pressure are discussed with the patient by the GP.

Implementation of the above-mentioned intervention is studied in two randomized groups of pharmacies. One group receives minimal support in the intervention, the other group also receives interactive educational meetings, reminders and feedback, and support of multiprofessional cooperation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • pharmacies: resident in the south of the Netherlands
  • patients:

    • 18 years or older
    • diagnosis of hypertension
    • systolic blood pressure between 150 and 180 mm Hg despite the use of antihypertensive drug(s)
    • indication for treatment escalation

Exclusion Criteria:

  • patients:

    • impossibility to establish blood pressure properly
    • patient treated by medical specialist
    • change of antihypertensive therapy because of adverse effects of current medication
    • insisting on using dose organisers
    • not managing their drug intake themselves
    • not able to come to the pharmacy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00460343

Sponsors and Collaborators
Radboud University
Zorgverzekeraar CZ
Scientific Institute for Dutch Pharmacists, The Netherlands
Investigators
Principal Investigator: Peter G de Smet, PhD Radboud University
Study Director: Michel Wensing, PhD Scientific Institute for Quality of Healthcare
  More Information

Publications:

Responsible Party: Caroline van de Steeg-van Gompel, Scientific Institute for Quality of Healthcare
ClinicalTrials.gov Identifier: NCT00460343     History of Changes
Other Study ID Numbers: WOK/WINAp/CZ-03, CMO-nr 2006/072
Study First Received: April 4, 2007
Last Updated: July 9, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
patient non-adherence
antihypertensive agents
community pharmacy services
professional roles

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014