Health Condition 1: I509- Heart failure, unspecified
Conditions
Interventions
Intervention1: NIL: NIL
Sponsors
Lupin Digital Health
Eligibility
Inclusion criteria
Inclusion criteria: Subjects aged more than 18 years or older Subjects who have a documented diagnosis of New York Heart Association NYHA class II and class III Heart Failure Patients willing to comply with the follow up plan set as per real world scenario Patient should have a smartphone and should be able to operate it Patient who has read the informed consent form has understood the relevant aspects of the study and grants his or her authorization to participate by signing the informed consent form before the inclusion in the study Patients with basic reading skills English Hindi Marathi
Exclusion criteria
Exclusion criteria: Patients unable to participate in self management programs or unable to operate smartphone for purposes of trial due to medical care needs vision hearing cognitive or dexterity impairment Patients who do not have the experience of operating mobiles or smartphones Patients with a history of psychiatric and neurological disorders Patients with impaired bilateral hearing or visual impairment which limits the use of smartphones Patients who are participating in other ongoing clinical trials or prospective cohort studies Female patients who are pregnant or lactating Patients with contraindications or severe physical disabilities that limit patients from participation Patients who are not willing to provide his or her own consent for participation in this study Patients who are unsuitable for any other reason to participate in the study in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in QoL by mean Dartmouth COOP Questionnaire scores Proportion of cardiac related hospital admissions since enrolment Number of unplanned or emergency hospital visits due to the cardiovascular cause since enrolment Mean number of hospital visits since enrolment till endlineTimepoint: at 1 Month 3 months and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Number and Percentage of patients with MACE cardiovascular CV death nonfatal myocardial infarction MI definite or probable stent thrombosis ST revascularization and clinically significant bleeding events To measure improvement in functional capacity by using 6-Minute Walk Distance Test Mean change in NT pro BNP parameters Mean changes in systolic SBP and diastolic blood pressure DBP in patients Mean Changes in blood sugar levels FBG PBG and HbA1c in T2DM patients Mean change in lab parameters such as lipid profile HDL LDL TG TC in Hypercholesterolemia patients Mean change in Lab parameters RBC WBC Hb Hematocrit Mean corpuscular volume MCV Reticulocyte count red cell distribution width Mean corpuscular hemoglobin concentration MCHC Iron Total Iron binding capacity Ferritin Transferin Folic Acid Vitamin B12 in anemic patients Proportion of patients with Adherence to cardiac medications Proportion of patients compliance to study visits Timepoint: at 1 Month 3 months and 6 months | — |
Countries
India
Contacts
Public ContactDr Rajesh Badani
Aditya Birla Memorial Hospital Chinchwad Pune
Outcome results
None listed