Remote Monitoring After Heart Failure

Study Overview
=================
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 about 368 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.

Official Title
-----------------
Individually Tailored Remote Monitoring at Home After Hospitalisation for HEART Failure in Multi-morbid Patients (IT-HEART): a Randomised Clinical Trial

Conditions
-----------------
Heart Failure Acute, Remote Monitoring, Nurse's Role

Intervention / Treatment
-----------------
* Other: Nurse-led remote monitoring program
* Other: Usual care treatment


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants were randomized 1:1 to a nurse-led remote monitoring program or to usual care
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Remote monitoring program | Other: Nurse-led remote monitoring program<br>* 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.<br>|
| Active Comparator: Usual care<br>Current clinical pratice at the participating hospitals | Other: Usual care treatment<br>* Usual care treatment and follow-up care at the outpatient clinic and in primary care<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of re-hospitalizations for heart failure and total death | Rate of re-hospitalizations for heart failure and total death at 12 months follow-up assessed from hospital medical records between the treatment arms | From time of randomization until 12 months follow-up | 
| Time to first re-hospitalization for heart failure and total death | Time to first re-hospitalization for heart failure and total death at 12 months follow-up assessed from hospital medical records between the treatment arms | From time of randomization until 12 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of total death | Rate of total death at 12 months follow-up assessed from hospital medical records between the treatment arms | From time of randomization until 12 months follow-up | 
| Rate of re-hospitalizations for heart failure | Rate of re-hospitalizations for heart failure at 12 months follow-up assessed from hospital medical records between the treatment arms | From time of randomization until 12 months follow-up | 
| Total number of days lost due to unplanned cardiovascular hospital admissions treatment arms | Percentage of days lost due to unplanned cardiovascular hospital admissions at 12 months follow-up between the treatment arms assessed from hospital medical records | From time of randomization until 12 months follow-up | 
| Changes in selfcare behaviour | 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. | From baseline until three months follow-up |