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

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Completed

CT.gov ID

NCT04326101

Collaborator

(none)

Enrollment

Location

13.4

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Other: Transmission of adherence records

Detailed Description

Patients with heart failure (HF) need multiple guideline-directed medications to control the systolic and/or diastolic ventricular dysfunction. To support clinical decision and to guide treatment at every stage of HF, the measurement of the biomarker NT-proBNP (N-terminal pro-B type natriuretic peptide) has been recommended.

Many patients (including HF patients) do not follow therapeutic recommendations. Non-adherence to treatment can lead to acute decompensation that often requires urgent hospitalisation. Electronic monitoring of medication intake gives precise information over time and is the gold standard to unveil inappropriate behaviour. We developed Time4MedTM, a small device that records date and time of medication intake. The recorded electronic data are visualized in a scatter diagram and several adherence estimates can be calculated such as days with missed doses, taking adherence or timing adherence. Electronic Health Records (EHR) are repository of patient health data in digital format and are mostly locally configured in medical practices.

This is a prospective, observational, feasibility study one medical practice in Basel-Stadt, one dedicated laboratory, and one community pharmacy as study centre.

Physicians will order NT-proBNP measurement and electronic adherence monitoring to patients with diagnosis New York Heart Association (NYHA) stage II-III, who are under guidelines-recommended multiple medications and whose clinical and/or biomedical targeted values are unmet (inadequate control). Laboratory and adherence reports will be generated in similar encrypted format and transferred via secured platform into physician's EHR.

We expect to show that electronic adherence reports can be gathered and electronically transferred by pharmacists into medical EHR in the same way as laboratory reports. The joint availability of medication adherence estimates and laboratory values in the EHR can guide physicians in the management and therapy of patients with HF.

Study Design

Study Type:

Observational

Actual Enrollment :

9 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Patient NT-proBNP Values and Medication Adherence on Their GP's Screen to Guide Dose Adjustment in Heart Failure (LabAdhDoc)

Actual Study Start Date :

Aug 15, 2020

Actual Primary Completion Date :

Sep 27, 2021

Actual Study Completion Date :

Sep 27, 2021

Outcome Measures

Primary Outcome Measures

Successful transmission [one month]
The adherence records transmitted by the pharmacy are available in the health records system of GPs

Secondary Outcome Measures

Physician satisfaction [through study completion, 1 year]
Satisfaction of physician with the availability of adherence records in his/her health records system

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Praxis Hammer	Basel		Switzerland	4057

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Investigators

Study Chair: Kurt E Hersberger, Prof, University of Basel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Basel, Switzerland

ClinicalTrials.gov Identifier:

NCT04326101

Other Study ID Numbers:

2019-01248

First Posted:

Mar 30, 2020

Last Update Posted:

Nov 29, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Nov 29, 2021