Pharmacy Implementation Trial: Adherence to Antihypertensive Therapy

NCT ID: NCT00460343

Last Updated: 2008-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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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 (MEMSĀ®). 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.

Conditions

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Hypertension

Keywords

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patient non-adherence antihypertensive agents community pharmacy services professional roles

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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max

Group Type EXPERIMENTAL

extensive implementation programme

Intervention Type 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.

min

Group Type ACTIVE_COMPARATOR

control

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

control

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zorgverzekeraar CZ

OTHER

Sponsor Role collaborator

Scientific Institute for Dutch Pharmacists, The Netherlands

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Scientific Institute for Quality of Healthcare

Principal Investigators

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Peter G de Smet, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Michel Wensing, PhD

Role: STUDY_DIRECTOR

Scientific Institute for Quality of Healthcare

Countries

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Netherlands

References

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Wetzels GE, Nelemans PJ, Schouten JS, Dirksen CD, van der Weijden T, Stoffers HE, Janknegt R, de Leeuw PW, Prins MH. Electronic monitoring of adherence as a tool to improve blood pressure control. A randomized controlled trial. Am J Hypertens. 2007 Feb;20(2):119-25. doi: 10.1016/j.amjhyper.2006.07.018.

Reference Type BACKGROUND
PMID: 17261454 (View on PubMed)

Ragot S, Sosner P, Bouche G, Guillemain J, Herpin D. Appraisal of the knowledge of hypertensive patients and assessment of the role of the pharmacists in the management of hypertension: results of a regional survey. J Hum Hypertens. 2005 Jul;19(7):577-84. doi: 10.1038/sj.jhh.1001859.

Reference Type BACKGROUND
PMID: 15830000 (View on PubMed)

Krousel-Wood M, Thomas S, Muntner P, Morisky D. Medication adherence: a key factor in achieving blood pressure control and good clinical outcomes in hypertensive patients. Curr Opin Cardiol. 2004 Jul;19(4):357-62. doi: 10.1097/01.hco.0000126978.03828.9e.

Reference Type BACKGROUND
PMID: 15218396 (View on PubMed)

Lee JK, Grace KA, Taylor AJ. Effect of a pharmacy care program on medication adherence and persistence, blood pressure, and low-density lipoprotein cholesterol: a randomized controlled trial. JAMA. 2006 Dec 6;296(21):2563-71. doi: 10.1001/jama.296.21.joc60162. Epub 2006 Nov 13.

Reference Type BACKGROUND
PMID: 17101639 (View on PubMed)

Burnier M, Schneider MP, Chiolero A, Stubi CL, Brunner HR. Electronic compliance monitoring in resistant hypertension: the basis for rational therapeutic decisions. J Hypertens. 2001 Feb;19(2):335-41. doi: 10.1097/00004872-200102000-00022.

Reference Type BACKGROUND
PMID: 11212978 (View on PubMed)

Waeber B, Vetter W, Darioli R, Keller U, Brunner HR. Improved blood pressure control by monitoring compliance with antihypertensive therapy. Int J Clin Pract. 1999 Jan-Feb;53(1):37-8.

Reference Type BACKGROUND
PMID: 10344064 (View on PubMed)

Carter BL, Zillich AJ, Elliott WJ. How pharmacists can assist physicians with controlling blood pressure. J Clin Hypertens (Greenwich). 2003 Jan-Feb;5(1):31-7. doi: 10.1111/j.1524-6175.2003.01460.x.

Reference Type BACKGROUND
PMID: 12556651 (View on PubMed)

Fahey T, Schroeder K, Ebrahim S. Interventions used to improve control of blood pressure in patients with hypertension. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD005182. doi: 10.1002/14651858.CD005182.

Reference Type BACKGROUND
PMID: 15654709 (View on PubMed)

Other Identifiers

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CMO-nr 2006/072

Identifier Type: -

Identifier Source: secondary_id

WOK/WINAp/CZ-03

Identifier Type: -

Identifier Source: org_study_id