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Completed

NCT Number: NCT00460343

Pharmacy Implementation Trial: Adherence to Antihypertensive Therapy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

extensive implementation programme

Other

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.

Control

Other

pharmacists only receive a written manual with instructions to implement the patient compliance intervention.

Primary outcomes

  1. the number of patients included for intervention

    Time frame: 9 months after start of the study

Secondary outcomes

  1. improvement of systolic blood pressure

    Time frame: 2 and 5 months after inclusion

  2. treatment escalation of patients after inclusion into the study

    Time frame: 5 months after inclusion

  3. the percentage of GP's in PTAM that cooperates in the intervention

    Time frame: 9 months after start of the study

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Scientific Institute for Dutch Pharmacists, The Netherlands
  • Zorgverzekeraar CZ

Registry information

Official study title

Implementation of a Pharmacy-Intervention to Establish and if Necessary Improve Adherence to Antihypertensive Therapy. A Cluster Randomized Trial.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 13, 2007
Registry last updated
Jul 10, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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