Pharmacy Implementation Trial: Adherence to Antihypertensive Therapy

NCT00460343 | Completed

• 2 other identifiers: WOK/WINAp/CZ-03CMO-nr 2006/072
• Study Type: interventional
• Target: 57
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hypertension

Keywords

patient non-adherence; antihypertensive agents; community pharmacy services; professional roles

Outcome Measures

Primary Outcomes (1)

• the number of patients included for intervention

  9 months after start of the study

Secondary Outcomes (3)

• improvement of systolic blood pressure

  2 and 5 months after inclusion

• treatment escalation of patients after inclusion into the study

  5 months after inclusion

• the percentage of GP's in PTAM that cooperates in the intervention

  9 months after start of the study

Study Arms (2)

max

EXPERIMENTAL

Other: extensive implementation programme

min

ACTIVE COMPARATOR

Other: control

Interventions

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.

max

control OTHER

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

min

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Zorgverzekeraar CZ: collaborator
• Scientific Institute for Dutch Pharmacists, The Netherlands: collaborator

Related Publications (8)

• 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.

  PMID: 15830000 BACKGROUND

• 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.

  PMID: 15218396 BACKGROUND

• 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.

  PMID: 17101639 BACKGROUND

• 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.

  PMID: 11212978 BACKGROUND

• 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.

  PMID: 10344064 BACKGROUND

• 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.

  PMID: 12556651 BACKGROUND

• 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.

  PMID: 15654709 BACKGROUND

• 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.

  PMID: 17261454 BACKGROUND

MeSH Terms

Conditions

Hypertension; Patient Compliance

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Peter G de Smet, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• Michel Wensing, PhD

  Scientific Institute for Quality of Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 4, 2007
• First Posted: April 13, 2007
• Study Start: April 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: June 1, 2008
• Last Updated: July 10, 2008

Record last verified: 2008-07