Chronic heart failure Circulatory System Heart failure, unspecified
Conditions
Interventions
The intervention group will receive the nurse-facilitated multidisciplinary follow-up (UTILE) intervention, consisting of seven European Society of Cardiology (ESC) guideline-recommended intervention
additional visits/contacts will be scheduled on a needs-led basis over the 3-months follow-up period.
Participants randomized to the enhanced usual care/control group will receive standard in-hospit
Sponsors
HFR Fribourg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. =18y of age 2. Diagnosed with HF in NYHA functional classes II-IV 3. Hospitalized in HFR Fribourg internal medicine for decompensated HF or another reason 4. History of hospitalization due to HF decompensation during the previous 6 months 5. Fluent in French or German
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 11/12/2020: 1. Imminently life-threatening illness 2. Short anticipated survival 3. Dementia 4. Complicating serious comorbidity (e.g., untreated psychiatric illness, untreated malignancy) 5. Cognitive impairment that would preclude written informed consent 6. Patients with COVID-19 7. Patients with a positive Sars-CoV2 test result 8. Patients with a positive anamnesis regarding Sars-CoV2 infection while waiting for the test result _____ Previous exclusion criteria: 1. Imminently life-threatening illness 2. Short anticipated survival 3. Dementia 4. Complicating serious comorbidity (e.g., untreated psychiatric illness, untreated malignancy) 5. Cognitive impairment that would preclude written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The patient recruitment rate (percentage of eligible patients agreeing to participate) will be measured consecutively at each day of recruitment, calculated by the number of patients screened for eligibility, number of eligible patients, number of eligible patients receiving information to participate in the study, and number of eligible patients agreeing to participate, will be noted by research assistants in the specific screening database (included in REDCap) at the end of each recruitment day. 2. Study nurse time needed for patient recruitment and inclusion into the study will be assessed for each day of recruitment by noting the time (hours, minutes) that the study nurse needs a) to recruit (time for eligibility screening, then to obtain eligibility confirmation from the treating physician) and b) to include the patient (i.e., provide study information to the patient and obtain informed consent, including returning after 24h). This information will be recorded in the specific screening database (included in REDCap) by the research assistants at the end of each recruitment day. 3. Study retention/attrition (percentage of participants remaining in the follow-up vs those who withdraw); fidelity to the intervention components, assessed using a seven-item fidelity check-list with yes/no responses regarding all intervention components, will be noted by the nurses during each consultation and provided to the study nurse; the percentage of patients receiving one visit, additional telephone contacts and/or home visits and the percentage who receive two or more such contacts will be calculated. The duration of each patient visit or telephone consultation will be noted by the nurse at each consultation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient-reported outcomes: 1.1. HF specific self-care is measured via the 22-item Swiss German and French version of the Self-Care of Heart Failure Index, v.6._2 (SCHFI) at baseline and 3-months follow-up. 1.2. HF specific health status and symptom stability is measured via the Swiss German and French version of the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ), with symptom stability measured via a single item from the KCCQ 23-item version at baseline and 3-months follow-up. 1.3. Health-related quality of life is measured via the French and German version of the 5-item EQ-5D-5L, including a VAS (Euroqol) at baseline and 3-months follow-up. 1.4. Intervention acceptability is measured via the Treatment Acceptability and Preference Questionnaire (the original 5-item TAPQ) adapted for this study resulting in an 8-item questionnaire at 3-months follow-up. 1.5 Patient perspectives (experience of receiving the intervention and their opinions of its value regarding the target outcomes) are determined using semi-structured interviews with each patient between 48 hours and 15 days after what is expected to be his/her final UTILE consultation. 2. Nurse and cardiologist perspectives regarding acceptability are measured using semi-structured one-to-one interviews with involved nurses and cardiologists to explore the nurses’ experiences regarding the intervention’s delivery, as well as both cardiologists’ and nurses’ individual perceptions and opinions regarding both UTILE follow-up care quality and their nurse-cardiologist collaboration. These one-to-one interviews will be held late in the trial, i.e., after the 60th participant has completed the follow-up period. 3. The general practitioners’ perspectives regarding acceptability are measured using semi-structured one-to-one interviews. 4. All-cause mortality for the three-month intervention period is recorded by the research assistant and as available via patient records or via the patients’ general practitioners | — |
Countries
Switzerland
Outcome results
None listed