Health Condition 1: I509- Heart failure, unspecified
Conditions
Interventions
Intervention1: Assisted Telemedicine with integrated Digital Health Technologies: This assisted-telemedicine solution is designed to improve healthcare accessibility for underserved populations by com
Sponsors
Centre for Chronic Disease Control
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients (adult) admitted presenting with symptoms such as dyspnea at rest, pulmonary congestion on chest x-ray and other HF signs and symptoms during screening done at discharge having clinical diagnosis of acute heart failure, with classification of heart failure as NYHA Class III or IV and HF with reduced Ejection Fraction (EF) of less than 40%. 2.The participant must be a smartphone user or someone in family must own a smartphone. 3.Patientâ??s residence should be within the same city as participating study site (hospital). 4. Treating cardiologists from each site will be included to participate in a cohort study for one of the secondary objectives to assess feasibility of GDMT implementation through the digital package.
Exclusion criteria
Exclusion criteria: 1.ACS or revascularization within 30 days 2.Expected or prior implantation of cardiac resynchronization device in past 3 months. 3. Heart transplant or expected heart transplant or left ventricular assist device implantation planned in the next 6 months. 4.HF secondary to significant correctable or reversible cause like primary valvular disease or correctable congenital heart disease (CHD) 5.Inability to comply with all study requirements due to major comorbidities, social or financial issues, or a history of non-compliance with medical regimens, that might compromise the patientâ??s ability to understand and/or comply with the protocol instructions or follow-up procedures 6. Psychiatric or neurological disorder, cirrhosis, or active malignancy leading to a life expectancy less than 6 months 7.Terminally ill, and, or presence of visual or cognitive impairment affecting ability to give informed consent, 8.Active infection at any time during the HF hospitalization prior to randomization based on abnormal temperature and elevated WBC count or need for intravenous antibiotics 9. End-stage renal disease requiring dialysis 10.Currently pregnant, or nursing (lactating) women 11.Concomitant severe valvular stenosis 12.Chronic inotropic therapy 13.Primary liver disease considered to be life threatening 14. If the patient is currently participating in any other clinical trials in the same hospital or any other sites.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary Outcome will be time to first cardiovascular event which is a composite outcome comprising all-cause mortality, and all-cause hospitalisation. Death due to worsening HF and other CVD. All-cause mortality. Unplanned HF hospitalization. Unplanned cardiovascular hospitalisation.Timepoint: At baseline, Month 3 and Month 6 post discharge of the HF patient | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiologist/Provider adherence to guideline-based titration. The proportion of patients achieving optimal GDMT titration. Barriers & facilitators to implementation (qualitative analysis).Timepoint: At Month 6 & Month 12 of the intervention period of the study for the treating cardiologists;Quality of life will be assessed using the Indian specific quality of life questionnaire (IHFQoL) & EQ5D5L at baseline, 3 months, & end of the study. Mental health will be assessed using the Patient Health Questionnaire (PHQ-9) at baseline, 3 months & 6 months. Medication Adherence Rating Scale (MARS) will be used to assess adherence to prescribed medication at 3 months & 6 months.Timepoint: At baseline, Month 3 & Month 6 post discharge of HF patient.;Total healthcare costs per Quality Adjusted Life Years (QALY) modelled using clinical data observed during the trial duration (including HF-related hospitalization, emergency visits, medications, & travel).Timepoint: At Month 3 & Month 6 post discharge of HF patient. | — |
Countries
India
Contacts
Public ContactDr Arun Pulikkottil Jose
Centre for Chronic Disease Control (CCDC)
Outcome results
None listed