Remote Monitoring After Heart Failure
- Conditions
- Remote MonitoringNurse's RoleHeart Failure Acute
- Interventions
- Other: Usual care treatmentOther: Nurse-led remote monitoring program
- Registration Number
- NCT05447598
- Lead Sponsor
- Vestre Viken Hospital Trust
- Brief Summary
Heart failure (HF) is a leading cause of hospitalisation and disability-adjusted life years lost, with mortality rates exceeding most cancers. Despite compelling evidence and recommendations, less than 20% of the HF patients are followed-up by the specialist healthcare after hospital discharge. Due to limited outpatient capacity, human resources and increasing incidence of HF over the next decades, new care models are obviously needed. Remote monitoring (i.e. telemonitoring) encompasses the use of audio, video and other telecommunication technologies to monitor patient status at a distance. Remote monitoring is a promising strategy that can facilitate rapid access to care when needed and reduce patient travel to hospital consultations. It also promotes self-care behaviour, psychosocial support, and early detection of cardiac decompensation. Despite intensive research for \>10 years, randomised trials show conflicting results, and European HF guidelines are confined to a weak (class IIb, level of evidence B) recommendation. More knowledge about the role of remote monitoring strategies in HF management, especially in the transition from hospital to home, is thus requested in the most recent European and US guidelines. In particular, studies of high-risk patients integrating the community health services are largely lacking. Furthermore, the components of the intervention that mediate the effect need to be identified. The proposed study aims to address these gaps in evidence and assess whether individually tailored remote monitoring at home (IT-HEART) is improves clinical outcomes in patients hospitalized with decompensated HF. We also aim to identify modifiable clinical and behavioural (drug adherence, self-care, psychological factors) outcome predictors. A prospective, multicentre, randomized, open-label, blinded endpoint adjudication (PROBE) intervention study is designed and powered to include at least 200 patients with at least one HF hospitalization in the 12 months preceding enrolment. To ensure generalizability, patients will be included regardless of comorbidity, frailty and ejection fraction. We have conducted a pilot-study providing empirical evidence for the expected participation rate, readmission rate and barriers to HF management in current clinical practice that will be targets for the intervention. This will promote high adherence to the intervention and positive long-term clinical and health economic effects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Age> 18 years
- Known HF diagnosis (ICD-10: I50) recorded in hospital medical records
- Admitted to hospital within 7 days before screening for acute HF with symptoms of decompensation including dyspnoea in NYHA class ≥ II, pulmonary congestion on chest x-ray and/or other signs like oedema or positive rales on auscultation and elevated NT-proBNP concentrations at screening
- Sign informed consent and expected to participate according to ICH / GCP
- Any condition (e.g. psychosis, alcohol abuse, dementia) or situation that may pose a significant risk to the participant, confuse the results or make participation unethical
- Not able to understand Norwegian language
- Short life expectancy (<6 months) due to non-cardiac causes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual care Usual care treatment Current clinical pratice at the participating hospitals Intervention Nurse-led remote monitoring program Remote monitoring program
- Primary Outcome Measures
Name Time Method Rate of re-hospitalizations for heart failure From time of randomization until 12 months follow-up Rate of re-hospitalizations for heart failure at 12 months follow-up assessed from hospital medical records between the treatment arms
Time to first re-hospitalization for heart failure From time of randomization until 12 months follow-up Time to first re-hospitalization for heart failure at 12 months follow-up assessed from hospital medical records between the treatment arms
- Secondary Outcome Measures
Name Time Method Total number of days lost due to unplanned heart failure admissions treatment arms From time of randomization until 12 months follow-up Percentage of days lost due to unplanned heart failure admissions at 12 months follow-up between the treatment arms assessed from hospital medical records
Total number of days lost due to unplanned hospital admissions treatment arms From time of randomization until 12 months follow-up Percentage of days lost due to unplanned hospital admissions at 12 months follow-up between the treatment arms assessed from hospital medical records
Rate of total death From time of randomization until 12 months follow-up Rate of total death at 12 months follow-up assessed from hospital medical records between the treatment arms
Rate of unplanned re-hospitalizations From time of randomization until 12 months follow-up Rate of re-hospitalizations at 12 months follow-up assessed from hospital medical records between the treatment arms
Changes in health-related quality of life From baseline until three months follow-up Changes in health-related quality of life measured by Kansas Cardiomyopathy Questionnaire 12-score (higher scores indicating better outcome).
Changes in selfcare behaviour From baseline until three months follow-up Changes in selfcare behaviour measured by the revised 9-item European Heart Failure Selfcare behaviour Scale assessed by patient self-report on a five-point scale from "totally agree" to "totally disagree".
Changes in symptom score and patient satisfaction From baseline until three months follow-up Changes in symptom score and patient satisfaction measured by the Edmonton Symptom Assessment System Revised scores (higher scores indicating better outcome).
Trial Locations
- Locations (3)
Vestfold Hospital Trust
🇳🇴Tønsberg, Vestfold And Telemark County, Norway
Vestre Viken Trust Drammen hospital
🇳🇴Drammen, Viken County, Norway
Akershus University Hospital
🇳🇴Lørenskog, Norway