Adherence Monitoring in Ambulatory Hypertensive Patients

NCT05215652 | Completed

• 1 other identifier: 2021-02392
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, 1 year

Secondary Outcomes (6)

• errors in medication use

  one month

• treatment adaptions

  one month

• Adherence counselling

  one month

• Medication adherence

  one month

• Blood pressure

  one month

Interventions

adherence monitoring package (AMoPac) OTHER

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.

Eligibility Criteria

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

Study Population

hypertensive patients nonresponding to pharmacotherapy

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Praxis Hammer

Basel, 4057, Switzerland

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: January 31, 2022
• Study Start: February 15, 2022
• Primary Completion: April 17, 2023
• Study Completion: April 17, 2023
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

CH (1)