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testing of a smartphone based remote monitoring application and behavioural interventions to improve selfcare in patients with chronic heart failure

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)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030576
Enrollment
300
Registered
2021-01-19
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Health Condition 1: I504- Combined systolic (congestive) anddiastolic (congestive) heart failure Health Condition 2: I509- Heart failure, unspecified

Interventions

Intervention1: selfcare behavior change intervention involving task sharing, brief psychological intervention and remote monitoring of chronic heart failure patients: The intervention package will be

Sponsors

St Johns Research Institute
Lead Sponsor
India Alliance DBT Wellcome trust
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
heart failure rehospitalization or all cause mortalityTimepoint: 12 months

Secondary

MeasureTime frame
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 Timepoint: 1 month, 3 months, 6 months and 12 months

Countries

India

Contacts

Public ContactImmaculate Sheela Josephine

st. Johns Research Institute/ St. Johns National Academy of Health Sciences

kamath.deepak@sjri.res.in9945519522

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026