Remote Monitoring After Heart Failure

Vestre Viken Hospital Trust

Status: Active, not recruiting

Conditions: Remote Monitoring; Nurse's Role; Heart Failure Acute

Treatments: Other: Nurse-led remote monitoring program; Other: Usual care treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05447598

464460

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

200 participants in 2 patient groups

Intervention

Experimental group

Description:

Remote monitoring program

Treatment:

Other: Nurse-led remote monitoring program

Usual care

Active Comparator group

Description:

Current clinical pratice at the participating hospitals

Treatment:

Other: Usual care treatment