Clinical trial NCT05447598: Remote Monitoring After Heart Failure
Official title: Individually Tailored Remote Monitoring at Home After Hospitalisation for HEART Failure in Multi-morbid Patients (IT-HEART): a Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure Acute
Remote Monitoring
Nurse's Role
Lead sponsor: Vestre Viken Hospital Trust
Sponsor class: OTHER
Collaborators: name: The Hospital of Vestfold
name: University of Oslo
name: Oslo University Hospital
name: University of Stavanger
name: University Hospital, Akershus
First posted: 2022-07-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomized 1:1 to a nurse-led remote monitoring program or to usual care
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Rate of re-hospitalizations for heart failure
timeFrame: From time of randomization until 12 months follow-up
measure: Time to first re-hospitalization for heart failure
timeFrame: From time of randomization until 12 months follow-up
Secondary outcomes:
measure: Rate of total death
timeFrame: From time of randomization until 12 months follow-up
measure: Rate of unplanned re-hospitalizations
timeFrame: From time of randomization until 12 months follow-up
measure: Total number of days lost due to unplanned heart failure admissions treatment arms
timeFrame: From time of randomization until 12 months follow-up
measure: Total number of days lost due to unplanned hospital admissions treatment arms
timeFrame: From time of randomization until 12 months follow-up
measure: Changes in selfcare behaviour
timeFrame: From baseline until three months follow-up
measure: Changes in health-related quality of life
timeFrame: From baseline until three months follow-up
measure: Changes in symptom score and patient satisfaction
timeFrame: From baseline until three months follow-up
Other outcomes:
Locations:
city: Tønsberg
country: Norway
facility: Vestfold Hospital Trust
state: Vestfold And Telemark County
city: Drammen
country: Norway
facility: Vestre Viken Trust Drammen hospital
state: Viken County
city: Lørenskog
country: Norway
facility: Akershus University Hospital
Study officials:
References: