HypertensionNCT00460343
Pharmacy Implementation Trial: Adherence to Antihypertensive Therapy
A study testing extensive implementation programme in people with Hypertension, run by Radboud University Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- extensive implementation programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- Apr 2007to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Implementation of a Pharmacy-Intervention to Establish and if Necessary Improve Adherence to Antihypertensive Therapy. A Cluster Randomized Trial.
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- extensive implementation programme, control
- Keywords
- patient non-adherence, antihypertensive agents, community pharmacy services, professional roles
- Medical subject headings
- Hypertension, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extensive implementation programmeOther
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.
controlOther
pharmacists only receive a written manual with instructions to implement the patient compliance intervention.
| Study group | Role | What they receive |
|---|---|---|
| max | Experimental | Not described Receives: Other: extensive implementation programme |
| min | Active comparator | Not described Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of patients included for intervention
Measured: 9 months after start of the study
Secondary outcomes (3)
improvement of systolic blood pressure
Measured: 2 and 5 months after inclusion
treatment escalation of patients after inclusion into the study
Measured: 5 months after inclusion
the percentage of GP's in PTAM that cooperates in the intervention
Measured: 9 months after start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionMay 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Zorgverzekeraar CZ, Scientific Institute for Dutch Pharmacists, The Netherlands
- Investigators
- Peter G de Smet, PhD, Principal investigator, Radboud University Medical CenterMichel Wensing, PhD, Study director, Scientific Institute for Quality of Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460343
- Sponsor's protocol ID
- WOK/WINAp/CZ-03
- Other IDs
- CMO-nr 2006/072
- Status last verified
- Jul 2008
- First submitted
- 4 Apr 2007
- Last updated
- 10 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15830000Krousel-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.
PubMed 15218396Lee 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.
PubMed 17101639Burnier 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.
PubMed 11212978Waeber 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.
PubMed 10344064Carter 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.
PubMed 12556651Fahey 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.
PubMed 15654709Wetzels 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.
PubMed 17261454
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Pharmacy-Intervention to Establish and if Necessary Improve Adherence to Antihypertensive Therapy. A Cluster Randomized Trial.
- ClinicalTrials.gov ID
- NCT00460343
- Acronym / sponsor ID
- WOK/WINAp/CZ-03
- Conditions
- Hypertension
- Keywords
- patient non-adherence, antihypertensive agents, community pharmacy services, professional roles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Zorgverzekeraar CZ, Scientific Institute for Dutch Pharmacists, The Netherlands
- Study start
- Apr 2007
- Primary completion
- May 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 13 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| max | Experimental | Other: extensive implementation programme |
| min | Active comparator | Other: control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- pharmacies: resident in the south of the Netherlands
- patients:
Key exclusion criteria (7 listed)
- patients:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extensive implementation programmeexperimental 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. | Other | max |
| controlpharmacists only receive a written manual with instructions to implement the patient compliance intervention. | Other | min |
Primary outcome
the number of patients included for intervention
Time frame: 9 months after start of the study
3 secondary outcomes
improvement of systolic blood pressure
Time frame: 2 and 5 months after inclusion
treatment escalation of patients after inclusion into the study
Time frame: 5 months after inclusion
the percentage of GP's in PTAM that cooperates in the intervention
Time frame: 9 months after start of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2008.
- Background: PubMed 15830000Ragot 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.
- Background: PubMed 15218396Krousel-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.
- Background: PubMed 17101639Lee 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.
- Background: PubMed 11212978Burnier 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.
- Background: PubMed 10344064Waeber 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.
- Background: PubMed 12556651Carter 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.
- Background: PubMed 15654709Fahey 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.
- Background: PubMed 17261454Wetzels 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter G de Smet, PhD principal investigator
Radboud University Medical Center
Michel Wensing, PhD study director
Scientific Institute for Quality of Healthcare
Questions about this trial
What is this clinical trial studying?
A study testing extensive implementation programme in people with Hypertension, run by Radboud University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of patients included for intervention (time frame: 9 months after start of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00460343, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2008.