Electronic Transmission of Laboratory and Adherence Records of Heart Failure Patients to General Practitioners Screen

NCT04326101 | Completed

• 1 other identifier: 2019-01248
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with heart failure (HF) need multiple guideline-directed medications to control the systolic and/or diastolic ventricular dysfunction. Laboratory measure the biomarker NT-proBNP (N-terminal pro-B type natriuretic peptide) to support clinical decision and to guide treatment at every stage of HF. Many patients (including HF patients) do not follow therapeutic recommendations. Electronic monitoring of medication intake gives precise information over time and is the gold standard to unveil inappropriate behaviour. Electronic Health Records (EHR) are repository of patient health data in digital format and are mostly locally configured in medical practices. We aim to transmit laboratory results of NT-proBNP and estimates of medication adherence into the EHR system of primary care providers, with the objective to guide treatment and dose adjustment of multiple medications in patients with HF. Our project is \*not\* to develop a telemonitoring system.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Successful transmission

  The adherence records transmitted by the pharmacy are available in the health records system of GPs

  one month

Secondary Outcomes (1)

• Physician satisfaction

  through study completion, 1 year

Interventions

Transmission of adherence records OTHER

Electronic transmission of patient adherence records by pharmacists into medical EHR (Electronic Health Records)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

suffers from heart failure NYHA II-III

You may qualify if:

• is ≥ 18 years old;
• was diagnosed with HF NYHA II-III;
• is under multiple regimen (ACE-Inhibitors and/or mineralocorticoid receptor antagonist (MRA) and/or betablocker (BB) and/or diuretic and/or other);
• did not reach targeted clinical and/or biomedical objectives (HF is inadequately controlled);
• self-administers medication (no help or supervision from a third person);
• is suspected of inappropriate intake behaviour;
• accepts to use the monitoring device for one month;
• accepts a home-visit from the study pharmacist one month later;
• signs the informed consent form.

You may not qualify if:

• \- Patients who are, in the opinion of the physician, unlikely to comply with the study schedule or are unsuitable for any other reason

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Praxis Hammer

Basel, 4057, Switzerland

Location

Related Publications (1)

• Dietrich F, Zeller A, Allemann S, Arnet I. Development and acceptance of a new adherence monitoring package to identify non-adherent patients with polypharmacy in primary care: a feasibility study. BMJ Open Qual. 2023 Feb;12(1):e002155. doi: 10.1136/bmjoq-2022-002155.

  PMID: 36849193 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Kurt E Hersberger, Prof

  University of Basel

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: March 30, 2020
• Study Start: August 15, 2020
• Primary Completion: September 27, 2021
• Study Completion: September 27, 2021
• Last Updated: November 29, 2021

Record last verified: 2021-11

Locations

CH (1)