Adherence Monitoring in Ambulatory Hypertensive Patients

Completed

• Conditions: Hypertension

• Registration Number: NCT05215652
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-01-18
• Study First Submitted QC: 2022-01-18
• Study First Posted: 2022-01-31
• Study Start: 2022-02-15
• Status Verified: 2023-04
• Primary Completion: 2023-04-17
• Study Completion: 2023-04-17
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Patients with the following inclusion criteria will be recruited:

• is ≥18 years old;
• is diagnosed with arterial hypertension;
• is prescribed at least 1 antihypertensive medication;
• self-administers medication;
• is suspected of a deviant medication intake behavior (non-adherence) e.g., because of insufficiently controlled blood pressure in spite of prescribed pharmacotherapy (nonresponding);
• accepts to use of an electronic monitoring device during the study period (either the Time4Med™ device or the monitoring app busybee™);
• signs the informed consent form;
• understands and speaks German.

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Usefulness of the adherence package AMoPac	through study completion, 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	one month	patient satisfaction with the electronic adherence monitoring (questionnaire)
treatment adaptions	one month	the impact of AMoPac on clinical decision-making (questionnaire)
Adherence counselling	one month	the impact of AMoPac on medication intake behaviour counselling (questionnaire)
Blood pressure	one month	the level of patient blood pressure control, measured at GP office at study entry and end-of-study visit
errors in medication use	one month	the types of critical errors in medication use made by hypertensive patients
Medication adherence	one month	the level of patient medication adherence (metrics: taking and timing adherence, correct dosing days)

Trial Locations

Locations (1)

Praxis Hammer; 🇨🇭 Basel, Switzerland