Remote Monitoring After Heart Failure

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

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.

Study Overview

• Status: Recruiting
• Conditions: Nurse's Role; Heart Failure Acute; Remote Monitoring
• Intervention / Treatment: Other: Nurse-led remote monitoring program; Other: Usual care treatment

• Study Type: Interventional
• Enrollment (Anticipated): 368
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John Munkhaugen, MD,PhD; Phone Number: +47 97524194; Email: johmun@vestreviken.no
• Study Contact Backup: Name: Elise Sverre, MD, PhD; Email: elisbj@vestreviken.no

Study Locations

• Norway
  • Vestfold And Telemark County
    • Tønsberg, Vestfold And Telemark County, Norway, 3103
      • Recruiting
      • Vestfold Hospital trust
      • Contact: Erlend Aune, MD, PhD; Email: Erlend.aune@siv.no
      • Contact: Vidar Ruddox, MD, PhD; Email: vidar.ruddox@siv.no
  • Viken County
    • Drammen, Viken County, Norway, 3004
      • Recruiting
      • Vestre Viken Trust Drammen hospital
      • Contact: Elise Sverre, MD, PhD; Email: elisbj@vestreviken.no
      • Contact: John Munkhaugen, MD, PhD; Phone Number: +4797524194; Email: johmun@vestreviken.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Remote monitoring program	Other: 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.
Active Comparator: Usual care; Current clinical pratice at the participating hospitals	Other: Usual care treatment; Usual care treatment and follow-up care at the outpatient clinic and in primary care

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

Collaborators and Investigators

• Sponsor: Vestre Viken Hospital Trust
• Collaborators: University of Oslo; Oslo University Hospital; The Hospital of Vestfold; University of Stavanger

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2023
• Primary Completion (Anticipated): September 30, 2025
• Study Completion (Anticipated): December 30, 2026

Study Registration Dates

• First Submitted: May 27, 2022
• First Submitted That Met QC Criteria: July 5, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 464460

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No