Remote Monitoring After Heart Failure

NCT ID: NCT05447598

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-25
• Study Completion Date: 2026-12-30

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.

Conditions

Heart Failure Acute; Remote Monitoring; Nurse's Role

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention

Remote monitoring program

Group Type: EXPERIMENTAL

Nurse-led remote monitoring program

Intervention Type: OTHER

Symptoms of disease progression, clinical parameters, medication adherence and follow-up needs will be reported by patients or with support from relatives or homecare nurses 2-4 times/months over a three months period using a digital platform. Telephone monitoring is planned for patients who are not able to comply with the digital platform. In addition, an individualized self-treatment plan for diuretics and lifestyle advice will be prepared, preferably together with relatives at the outpatient clinic. Participants will also have access to a website with written information and videos about HF and self-management. Finally, a pillbox will be delivered to facilitate drug adherence.

Usual care

Current clinical pratice at the participating hospitals

Group Type: ACTIVE_COMPARATOR

Usual care treatment

Intervention Type: OTHER

Usual care treatment and follow-up care at the outpatient clinic and in primary care

Interventions

Nurse-led remote monitoring program

Symptoms of disease progression, clinical parameters, medication adherence and follow-up needs will be reported by patients or with support from relatives or homecare nurses 2-4 times/months over a three months period using a digital platform. Telephone monitoring is planned for patients who are not able to comply with the digital platform. In addition, an individualized self-treatment plan for diuretics and lifestyle advice will be prepared, preferably together with relatives at the outpatient clinic. Participants will also have access to a website with written information and videos about HF and self-management. Finally, a pillbox will be delivered to facilitate drug adherence.

Intervention Type: OTHER

Usual care treatment

Usual care treatment and follow-up care at the outpatient clinic and in primary care

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital of Vestfold

OTHER

Sponsor Role: collaborator

University of Oslo

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: collaborator

University of Stavanger

OTHER

Sponsor Role: collaborator

University Hospital, Akershus

OTHER

Sponsor Role: collaborator

Vestre Viken Hospital Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Vestfold Hospital Trust

Tønsberg, Vestfold and Telemark County, Norway

Vestre Viken Trust Drammen hospital

Drammen, Viken County, Norway

Akershus University Hospital

Lørenskog, , Norway

Countries

Norway

Other Identifiers

464460

Identifier Type: -

Identifier Source: org_study_id