Heart FailureLabAdhDocNCT04326101
Electronic Transmission of Laboratory and Adherence Records of Heart Failure Patients to General Practitioners Screen
An observational study of Heart Failure, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- Transmission of adherence records
- How many people
- 9 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Aug 2020to 27 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: suffers from heart failure NYHA II-III
Who may be able to join
- 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;
Show all 9Show fewer
- 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.
Who cannot join
- Patients who are, in the opinion of the physician, unlikely to comply with the study schedule or are unsuitable for any other reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient NT-proBNP Values and Medication Adherence on Their GP's Screen to Guide Dose Adjustment in Heart Failure (LabAdhDoc)
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.
Read the 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.
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.
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.
- Conditions
- Heart Failure
- Being tested
- Transmission of adherence records
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transmission of adherence recordsOther
Electronic transmission of patient adherence records by pharmacists into medical EHR (Electronic Health Records)
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful transmission
The adherence records transmitted by the pharmacy are available in the health records system of GPs
Measured: one month
Secondary outcomes (1)
Physician satisfaction
Satisfaction of physician with the availability of adherence records in his/her health records system
Measured: through study completion, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start15 Aug 2020
- Primary completion27 Sep 2021
- Study completion27 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kurt E Hersberger, Prof, Study chair, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326101
- Sponsor's protocol ID
- 2019-01248
- Other IDs
- 2019
- Acronym
- LabAdhDoc
- Status last verified
- Nov 2021
- First submitted
- 24 Mar 2020
- Last updated
- 29 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36849193
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient NT-proBNP Values and Medication Adherence on Their GP's Screen to Guide Dose Adjustment in Heart Failure (LabAdhDoc)
- ClinicalTrials.gov ID
- NCT04326101
- Acronym / sponsor ID
- LabAdhDoc / 2019-01248
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 30 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- suffers from heart failure NYHA II-III
Key inclusion criteria (9 listed)
- 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);
Key exclusion criteria (1 listed)
- Patients who are, in the opinion of the physician, unlikely to comply with the study schedule or are unsuitable for any other reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transmission of adherence recordsElectronic transmission of patient adherence records by pharmacists into medical EHR (Electronic Health Records) | Other | – |
Primary outcome
Successful transmission
Time frame: one month
The adherence records transmitted by the pharmacy are available in the health records system of GPs
1 secondary outcome
Physician satisfaction
Time frame: through study completion, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2021.
- Derived from this study: PubMed 36849193Dietrich 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kurt E Hersberger, Prof study chair
University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful transmission (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04326101, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2021.