An observational study in Hypertension, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-27.
Sponsored by University Hospital, Basel, Switzerland · Observational
Hypertension is a major risk factor for stroke, ischaemic heart disease, and kidney disease. One major cause for uncontrolled blood pressure in spite of prescribed pharmacotherapy was found to be non-adherence including erratic use of prescribed medication.
General practitioners (GP) face limitations when a guideline-conform therapy fails. A new tool to measure and assess medication adherence could be useful to identify patients who are not using medicine as prescribed. This provides new opportunities for patient-specific recommendations and adjustments of treatment.
Our aim is to assess the usefulness of the adherence package AMoPac to identify non-adherence in hypertensive patients nonresponding to treatment in daily practice.
Patients with hypertension are usually asymptomatic and do not feel an immediate benefit when taking their medication. This can result in early treatment interruption, omitted doses or drug holidays. Especially when side effects occur, which is often reported for diuretics and ACE inhibitors, patients tend to take their medicines less regularly or even to omit them. Furthermore, it is known that adherence decreases with the increased number of daily medicines. Patients with polypharmacy are thus particularly affected by non-adherence, that is almost inevitable in hypertensive treatment using dual, triple or quadruple therapy. Erratic use of prescribed medication including non-adherence is a major cause for uncontrolled blood pressure. However, practical and reliable methods are missing to screen patients for non-adherence.
The investigators have developed the adherence monitoring package (AMoPac) to help identifying non-adherence in ambulatory hypertensive patients. AMoPac is a tool that consists of an electronic monitoring device (Time4Med™ or smart phone application), data management and data analysis, feedback on patient's performance and clinical-pharmaceutical evaluation of medication adherence. The purpose is to transmit a patient-specific adherence report (including adherence recommendations) to the the GP.
This study is a prospective, observational study. GPs will recruit hypertensive patients during their routine visits. Patients will monitor daily medication intake at home for 4 weeks. A pharmacist will visit the patient at home to download the adherence data and to give feedback. The patient will then visit the GP who will have already received the adherence report and will have the opportunity to intervene, for example by adapting the patient's treatment or their medication use behavior. The 4-weeks cycle of adherence monitoring can be repeated if needed.
The investigators expect that AMoPac is useful for GPs to identify non-adherence in hypertensive patients nonresponding to treatment.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 15 is below the median of 210 across 1,359 observational studies indexed under Hypertension.
Browse Hypertension studies →University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.
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hypertensive patients nonresponding to pharmacotherapy
Patients with the following inclusion criteria will be recruited:
Patients who are using a pillbox, an app or reminders for medication management will not be excluded.
Exclusion Criteria:
Patients who are, in the opinion of the GP, unlikely to comply with the study schedule or are unsuitable for any other reason will be excluded.
AMoPac is a tool that consists of * an electronic monitoring device, * data management and data analysis, * feedback on patient's performance, * clinical-pharmaceutical evaluation of medication adherence, * transmission of an adherence report.
Usefulness of the adherence package AMoPac
The primary objective is to assess the usefulness of the adherence package AMoPac to identify non-adherence in hypertensive patients nonresponding to treatment in daily practice. It is defined as ≥75% of participating GPs who rate that the AMoPac is useful to identify hypertensive patients nonresponding to treatment as non-adherent.
Time frame: through study completion, 1 year
errors in medication use
the types of critical errors in medication use made by hypertensive patients
Time frame: one month
treatment adaptions
the impact of AMoPac on clinical decision-making (questionnaire)
Time frame: one month
Adherence counselling
the impact of AMoPac on medication intake behaviour counselling (questionnaire)
Time frame: one month
Medication adherence
the level of patient medication adherence (metrics: taking and timing adherence, correct dosing days)
Time frame: one month
Blood pressure
the level of patient blood pressure control, measured at GP office at study entry and end-of-study visit
Time frame: one month
Patient satisfaction
patient satisfaction with the electronic adherence monitoring (questionnaire)
Time frame: one month
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland