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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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05447598
Enrollment
200
Registered
2022-07-07
Start date
2023-04-25
Completion date
2026-12-30
Last updated
2025-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure Acute, Remote Monitoring, Nurse's Role

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.

Interventions

OTHERNurse-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.

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

Sponsors

The Hospital of Vestfold
CollaboratorOTHER
University of Oslo
CollaboratorOTHER
Oslo University Hospital
CollaboratorOTHER
University of Stavanger
CollaboratorOTHER
University Hospital, Akershus
CollaboratorOTHER
Vestre Viken Hospital Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Participants were randomized 1:1 to a nurse-led remote monitoring program or to usual care

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of re-hospitalizations for heart failureFrom time of randomization until 12 months follow-upRate of re-hospitalizations for heart failure at 12 months follow-up assessed from hospital medical records between the treatment arms
Time to first re-hospitalization for heart failureFrom time of randomization until 12 months follow-upTime to first re-hospitalization for heart failure at 12 months follow-up assessed from hospital medical records between the treatment arms

Secondary

MeasureTime frameDescription
Total number of days lost due to unplanned heart failure admissions treatment armsFrom time of randomization until 12 months follow-upPercentage of days lost due to unplanned heart failure admissions at 12 months follow-up between the treatment arms assessed from hospital medical records
Total number of days lost due to unplanned hospital admissions treatment armsFrom time of randomization until 12 months follow-upPercentage of days lost due to unplanned hospital admissions at 12 months follow-up between the treatment arms assessed from hospital medical records
Rate of total deathFrom time of randomization until 12 months follow-upRate of total death at 12 months follow-up assessed from hospital medical records between the treatment arms
Changes in health-related quality of lifeFrom baseline until three months follow-upChanges in health-related quality of life measured by Kansas Cardiomyopathy Questionnaire 12-score (higher scores indicating better outcome).
Changes in symptom score and patient satisfactionFrom baseline until three months follow-upChanges in symptom score and patient satisfaction measured by the Edmonton Symptom Assessment System Revised scores (higher scores indicating better outcome).
Changes in selfcare behaviourFrom baseline until three months follow-upChanges 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.
Rate of unplanned re-hospitalizationsFrom time of randomization until 12 months follow-upRate of re-hospitalizations at 12 months follow-up assessed from hospital medical records between the treatment arms

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026