CTRI/2021/01/030576已完成不适用
A multicenter, randomized controlled trial evaluating a theory driven, behavior change intervention centered on mobile health and task sharing to improve self-care and outcomes in patients with chronic heart failure. PANACEA- HF trial (Part of the PANACEA -HF project)
St Johns Research Institute3 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年1月25日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- heart failure rehospitalization or all cause mortality
研究概览
简要总结
The intervention aims to improve selfcare among patients with chronic heart failure with the objective of reducing heart failure related re-hospitalizations and mortality. The intervention comprises a trained health worker mediated, (i) systematic education (ii) simple evidence informed behaviour change techniques delivered by health workers, (iii) remote monitoring of symptoms and key patient parameters through telemedical modality respectively. The intervention will be on top of standard care and will be compared with the standard care only arm
研究设计
- 研究类型
- Interventional
- 分配方式
- Adaptive randomization, such as minimization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •In-patients,1,Patients with a clinical diagnosis of heart failure on a high ceiling diuretic,2,In NYHA class I, II or III after stabilization and shifted to the general ward, commenced on a Renin Angiotensin Aldosterone (RAAS) blocker and or a beta blocker or vasodilator,3 If in NYHA IV, daily dose of Furosemide or high ceiling diuretic equivalent 100 mg day at discharge Out-patients, 1, Patients with a prior clinical diagnosis of chronic heart failure, 2, In NYHA class I, II or III with a history of at least 1 re-hospitalization in the last 12 months, 3, Currently on a RAAS blocker and or beta blocker vasodilator, 4, Either a history of or currently on a high ceiling diuretic.
排除标准
- •In-patients, 1, Patients in acute heart failure with a reversible cause for heart failure as judged by the treating cardiologist or internist, 2, Acute Kidney Injury due to heart failure which precludes the use of Renin,Angiotensin,Aldosterone blockers until discharge maybe considered for inclusion during OPD follow-up if RAAS blockers commenced, 3, Diagnosed with end stage renal disease or requiring renal replacement therapy, 4, Hemodynamic instability or shock requiring vasopressors in the current admission, 5, Patients with clinically diagnosed severe mental illness such as severe depression Or patients with moderate depression and no caregivers, 6, Patients having significant cognitive dysfunction during screening and have no caregiver, 7, Patients who in the opinion of the treating physician has a poor prognosis with foreseen survival less than 12 months Out-patients, 1, Renal function status precludes the use of RAAS blockers, 2, End stage renal disease requiring any form of renal replacement therapy, 3, Patients having significant cognitive dysfunction during screening and have no caregiver, 4, Patients who in the opinion of the treating physician has a poor prognosis with foreseen survival less than 12 months.
结局指标
主要结局
heart failure rehospitalization or all cause mortality
时间窗: 12 months
次要结局
- Secondary Outcome Measures, 1, average days in hospital per patient per month, 2,total heart failure rehospitalizations at 12 months, 3, death due to cardiovascular at 12 months, 4, quality of life scores using EQ5D5L and KCCQ12 at 1, 6 and 12 months, 5, persistence to RAAS blocker and beta-blockers at 1, 3, 6 and 12 months, change in selfcare score measured using Selfcare in heart failure index (SCHFI) from baseline to 1, 6 and 12 months in the intervention group
研究者
研究点 (3)
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