Development, validation and testing mobile application-based remote patient management for patients with heart failure

Phase 3

Not yet recruiting

• Conditions: Heart failure, unspecified,

• Registration Number: CTRI/2025/04/085637
• Lead Sponsor: Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER

Brief Summary

The study registered is the third phase of development, validation, and testing of a mobile application-based remote patient management for Heart failure patients. It is a randomized, parallel-group, double-blinded, single-centered study, with a sample size of 100 patients. The primary outcome will be six-minutes walk test distance measured at six months. The secondary outcome measures will also be measured at six months, which will include- number of unplanned heart failure-related admissions, time to all-cause unplanned readmission or death, number of HF hospital days, change in NYHA class, self-care (SCHFI) score,(quality of life (EQ-5D-3L) score, medication adherence (ARMS-SF) score, NT-proBNP and physiological parameters.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-04-22
• Study Start: 2025-05-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Documented diagnosis of Heart Failure Reduced Ejection Fraction by echocardiography (LVEF less than 45%) Admitted as an inpatient and planned for discharge NYHA functional Class II to III Owns an android smartphone and able to read and write English or Tamil fluently Willing to undertake self-measurement of vital parameters.

Exclusion Criteria

Patients residing in nursing homes/care homes Visual/Cognitive/Physical/Psychological impairment Significant comorbidities like Severe COPD with Cor-pulmonale/ Severe Pulmonary Hypertension/ Cancer on palliative therapy with less than six month survival Severe Stenosis of any heart valve awaiting surgery ESRD on Renal replacement therapy Major surgery scheduled within 6 months (CABG/ Valve replacement, etc.) Pregnancy Cyanotic congenital heart disease On home oxygen / ventilator therapy Alcohol/Substance dependence Morbid Obesity (BMI less than 40).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Six minutes walk test	6th month

Secondary Outcome Measures

Name	Time	Method
number of unplanned heart failure-related admissions, time to all-cause unplanned readmission or death, number of HF hospital days, change in NYHA class, self-care (SCHFI) score,(quality of life (EQ-5D-3L) score, medication adherence (ARMS-SF) score, NT-proBNP and physiological parameters	6th month

Trial Locations

Locations (1)

Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER); 🇮🇳 Pondicherry, PONDICHERRY, India

Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)

🇮🇳Pondicherry, PONDICHERRY, India

Dr Lakshmi Ramamoorthy

Principal investigator

9842399340

laxmi_ramamoorthy@yahoo.com