testing of a smartphone based remote monitoring application and behavioural interventions to improve selfcare in patients with chronic heart failure
- Conditions
- Health Condition 1: I504- Combined systolic (congestive) anddiastolic (congestive) heart failureHealth Condition 2: I509- Heart failure, unspecified
- Registration Number
- CTRI/2021/01/030576
- Lead Sponsor
- St Johns Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 301
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method heart failure rehospitalization or all cause mortalityTimepoint: 12 months
- Secondary Outcome Measures
Name Time Method <br/ ><br>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 <br/ ><br>Timepoint: 1 month, 3 months, 6 months and 12 months