Digital, climate-sensitive heart failure management in general practice

Digital, climate-sensitive heart failure management in general practice - PIA-HF

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00038700

Enrollment

780

Registered

2025-12-11

Start date

2026-02-02

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I50

Interventions

Group 1: Study Part I - Feasibility (one arm) 6 primary care practices with one doctor and one medical assistant each 18 patients (3 per practice) This feasibility study tests the digital PIA-HF-ICT

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients: Stable Chronic Heart Failure (ICD-10: I50.-) Age is = 18 Stage II-IIIEmergency treatment in a practice, emergency room, and/or hospital due to HF (Heart Failure) in the last 2 years Uses a smart device = 3x/week Ejection fraction < 50 Understands study documentationInsured under the statutory health insurance (GKV-versichert) Practice Staff: The physician is certified as a specialist in general medicine (Facharzt für Allgemeinmedizin), a general practitioner-level internist, or a general practitioner Practice treats patients with heart failure Practice has = 1 MFA

Exclusion criteria

Exclusion criteria: Patients: Cognitive impairments (Planned) cardiac assist devices (e.g., VADs) Pregnancy/breastfeeding Dialysis Other severe illness Practice Staff: Practice is specialized in cardiology/Group practice (Gemeinschaftspraxis) Practice has no internet access

Design outcomes

Primary

Measure	Time frame
In Study Part I, the acceptance and user-friendliness of PIA-HF will be evaluated and demonstrated from the perspective of patients, general practitioners (GPs), and medical assistants (MFA). Primary Endpoint: Acceptance and user-friendliness (G-MAUQ) post-intervention. In Study Part II, it will be demonstrated that patients' self-management improves and hospital days are reduced. Patient Level: Self-management score (G9-EHFScBS) post-intervention. Care Level: Hospital days post-intervention. Data sources: The data will be collected using questionnaires, information from the patient file in the general practitioner's office, entries in the PIA-HF-ICT, and from the thermometer data logger. (In addition, statutory health insurance (GKV) routine data will be analyzed in Study Part II).	—

Measure

Time frame

In Study Part I, the acceptance and user-friendliness of PIA-HF will be evaluated and demonstrated from the perspective of patients, general practitioners (GPs), and medical assistants (MFA). Primary Endpoint: Acceptance and user-friendliness (G-MAUQ) post-intervention. In Study Part II, it will be demonstrated that patients' self-management improves and hospital days are reduced. Patient Level: Self-management score (G9-EHFScBS) post-intervention. Care Level: Hospital days post-intervention. Data sources: The data will be collected using questionnaires, information from the patient file in the general practitioner's office, entries in the PIA-HF-ICT, and from the thermometer data logger. (In addition, statutory health insurance (GKV) routine data will be analyzed in Study Part II).

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Secondary

Measure	Time frame
In addition, the following further project goals apply in Study Part I: Assessment and analysis of needs Presentation of the potential for implementation and integration into everyday primary care Evaluation of practicality and adjustment requirements Limited statements on effectiveness Collection and identification of weather-related health influences In addition, the following further project goals apply in Study Part II: Increase in therapy adherence Improvement of treatment processes and quality Increase in satisfaction with care from the patient and practice perspective Data sources: The data will be collected using questionnaires, information from the patient file in the general practitioner's office, entries in the PIA-HF-ICT, and from the thermometer data logger. (In addition, statutory health insurance (GKV) routine data will be analyzed in Study Part II).	—

Measure

Time frame

In addition, the following further project goals apply in Study Part I: Assessment and analysis of needs Presentation of the potential for implementation and integration into everyday primary care Evaluation of practicality and adjustment requirements Limited statements on effectiveness Collection and identification of weather-related health influences In addition, the following further project goals apply in Study Part II: Increase in therapy adherence Improvement of treatment processes and quality Increase in satisfaction with care from the patient and practice perspective Data sources: The data will be collected using questionnaires, information from the patient file in the general practitioner's office, entries in the PIA-HF-ICT, and from the thermometer data logger. (In addition, statutory health insurance (GKV) routine data will be analyzed in Study Part II).

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Countries

Germany

Contacts

Public ContactNora Mueller

Institute für Hausarztmedizin

nora.mueller@ukbonn.de+4922828710177

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026