ACTRN12626000858392进行中（未招募）不适用
HF-REACH (Heart Failure - Remote Equitable Australian Care through Healthcare Innovation) A Parallel Pragmatic Randomised Controlled Trial of Nurse-Led mHealth Heart Failure Management across Regional Australia to determine its effectiveness on heart failure symptoms/hospitalisation at 6 months
CardioNexus Remote Monitoring Pty Ltd0 个研究点目标入组 900 人开始时间: 2026年7月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 900
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 No limit（—）
- 性别
- All
入选标准
- •Age greater than 18 years
- •Established diagnosis of chronic HF (HFrEF or HFpEF) documented in the medical record, based on prior clinical assessment consistent with contemporary guidelines
- •Receiving community-based care for HF at the time of enrolment (i.e., not currently an inpatient)
- •Access to a mobile phone or internet-enabled device capable of supporting the mHealth platform (with assistance if required, or study device provided if necessary)
- •Able to provide informed consent in English
- •Willing to participate for the 6-month study duration
排除标准
- •Participants meeting ANY of the following criteria will be excluded:
- •Specialist HF Phenotypes: Participants with known or suspected specialist HF phenotypes requiring disease-specific management pathways, including:
- •Cardiac amyloidosis
- •Pulmonary arterial hypertension
- •Congenital heart disease
- •Hypertrophic cardiomyopathy
- •Active myocarditis
- •Advanced HF: Currently listed for heart transplantation/ left ventricular assist device (LVAD) support
- •Planned Procedures: Planned cardiac surgery or advanced interventional procedures within the study's 6-month follow-up period
- •Severe Comorbidity: Life expectancy <6 months unrelated to HF (in the investigator's clinical judgment)
- •Cognitive and Communication Barriers: Cognitive impairment without a capable carer)/ Insufficient English language proficiency
- •Technology Barriers: No access to a smartphone or internet-enabled device
- •Mental Health: Severe mental illness that would prevent safe participation (e.g., active psychosis, severe untreated depression with suicidal ideation)
- •Other Clinical Trials: Enrolled in another interventional clinical trial with overlapping interventions (Participation in observational studies or non-overlapping intervention trials is permitted).
- •Residential Status: Residing in nursing home or residential aged care facility where daily monitoring would be impractical (Retirement villages and independent living facilities are NOT exclusions if participant manages their own care).
- •Geographic Instability: Planning to relocate outside Australia within the 6-month study period
- •Previous Participation: Previously enrolled in this study (participants cannot re-enrol)
- •Investigator Discretion: Any other condition or circumstance that, in the opinion of the investigator, would make participation unsafe or impractical
研究者
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