Chronic heart failure
Conditions
Interventions
Group 1: Feasibility Study
Telemonitoring (daily entry of blood pressure, weight, heart rate, and subjective well-being via a digital health platform), structured nursing care (video consultations/tel
training sessions delivered by a Heart Failure Nurse), and digitally supported medication management using a smart medication dispenser provided to all patients for 1 month.
Subsequently, over a peri
training by a Heart Failure Nurse), and digitally supported medication management via a smart medication dispenser.
Group 2: Telemonitoring (daily entry of blood pressure, weight, heart rate, and subj
training sessions delivered by a Heart Failure Nurse), and digitally supported medication management using a smart medication dispenser provided to all patients for 1 month.
Arm 2:
Telemonitoring (da
training by a Heart Failure Nurse).
Sponsors
Universitätsklinik und Poliklinik für Innere Medizin III der Universitätsmedizin Halle (Saale)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Chronic heart failure (ICD-10: I50, NYHA class II–III) as a primary or secondary diagnosis - Treatment approach: conservative, pharmacological heart failure therapy
Exclusion criteria
Exclusion criteria: - Lack of capacity to provide informed consent - Age <18 years - Pregnancy - Participation in other clinical trials - Existing enrolment in a cardiology-based telemedicine programme - End-stage heart failure, including ventricular assist device (VAD), heart transplantation and/or therapeutic limitations - Life expectancy <1 year (cardiac or non-cardiac causes) - Acute coronary syndrome/myocardial infarction within the past 12 months - End-stage renal disease (on dialysis, or GFR <15 ml/min) - Impaired or absent treatment adherence (e.g. due to dementia, alcohol or drug abuse) - Limitations in access, use, or handling of the telemonitoring platform (e.g. intellectual disability, paralysis, blindness, dementia) - Congenital heart defects (Grown-Up Congenital Heart Disease – GUCH) - Specific cardiomyopathies (e.g. hypertrophic [HOCM], arrhythmogenic right ventricular [ARVC], restrictive [RCMP], peripartum cardiomyopathy [PPCM]) - Acute or active myocarditis (<12 months) - Liver cirrhosis (hepatorenal syndrome, Child-Pugh class B or C)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Characteristics and Barriers of the Care Model in Relation to Promoting Medication Adherence and Self-Management Initial characteristics and insights regarding potential barriers of the care model are identified based on findings from the preceding DigitHAL HF-Net study and the complementary evidence synthesis conducted as part of the needs assessment. During the clinical test phase, additional feedback will be gathered at multiple time points: through a telephone interview conducted four weeks after study enrolment (t0), via a focus group discussion three months after enrolment (t1), and in a final workshop following completion of the clinical test phase (after 6 months, t2). Furthermore, the documentation of telephone contacts and chat messages will also be analysed with a focus on identifying structural features and barriers to supporting adherence and self-management. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Adherence, Self-Care and Health Literacy, Medication Knowledge, Quality of Life, Usability of the Technologies, and Heart Failure-Specific Physical and Mental Condition Data on adherence regarding telemonitoring (regularity of data entry) and medication intake (taken on time / taken late or missed) are exported daily throughout the entire six-month clinical test phase using the technologies employed (CHES and ANABOX®smart). To assess medication adherence, the Medication Adherence Report Scale (MARS-D) will also be administered at measurement points t0 and t2. The remaining patient-reported outcomes (PROs) will be collected in a system-supported manner via the CHES health platform using validated instruments: European Heart Failure Self-care Behaviour Scale (G9-EHFScBS) Health Literacy Questionnaire (HLQ-G) Kansas City Cardiomyopathy Questionnaire (KCCQ-12) System Usability Scale (SUS) The physical and mental condition of participants will be assessed at t0 and t2 as part of a heart failure-specific medical examination and by means of the Patient Health Questionnaire (PHQ-9). Feasibility, Usability and Impact of the Care Model on Disease Management - As with the primary outcome, these endpoints will also be based on qualitative interviews with the participants. Characteristics of the Care Model for Sustainable Integration into Routine Care (Economic, Structural, Political, Clinical-Practical, Scientific) - The structural, clinical-practical and scientific features relevant for the sustainable integration of the care model into routine care will be identified through both the needs assessment and the clinical test phase. These features will be derived from a multi-perspective approach based on various sources and stages of the implementation process: - the systematic evidence synthesis and needs assessment at the beginning of the project, - feedback from participants and stakeholders gathered during the qualitative evaluations within the | — |
Countries
Germany
Contacts
Public ContactMadeleine Ritter-Herschbach
AG Versorgungsforschung/Pflege im Krankenhaus, Department für Innere Medizin, Universitätsmedizin Halle (Saale)
Outcome results
None listed