Pharmacy Implementation Trial: Adherence to Antihypertensive Therapy

Study Overview
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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 (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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Other: extensive implementation programme
* Other: control


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: max<br> | Other: extensive implementation programme<br>* 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.<br>|
| Active Comparator: min<br> | Other: control<br>* pharmacists only receive a written manual with instructions to implement the patient compliance intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of patients included for intervention |  | 9 months after start of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient non-adherence, antihypertensive agents, community pharmacy services, professional roles