Effects of Mobile Apps for Heart Failure Management on the Prognosis and Quality of Life of Patients with Chronic Heart Failure

JRCT ID: jRCT1040230122

Registered date:25/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic heart failure
• Date of first enrollment: 01/01/2024
• Target sample size: 500
• Study type: Interventional
• Intervention(s): The application will be installed on the study participants' smartphones, and blood pressure, pulse, weight, and symptoms will be entered 1-2 times daily (morning and evening) (about 3 minutes per session). Based on the information entered, the possibility of a heart failure exacerbation is automatically calculated by a scoring system, and if there is a possibility of a heart failure exacerbation, the patient is alerted. In addition, periodic (about once every two weeks) messages encouraging self-management and messages regarding precautions in the treatment of heart failure are sent via text at irregular intervals.

Outcome(s)

• Primary Outcome: Hospitalization for heart failure at 24 weeks

Secondary Outcome

- All-cause and cardiovascular death (24, 48, and 96 weeks)
- Hospitalization for heart failure (48 and 96 weeks)
- Kansas City Cardiomyopathy Questionnaire (KCCQ)-CS (Clinical Summary) score, KCCQ-TS (Total Symptom) change from baseline in KCCQ-TS (Total Symptom) score, KCCQ-OS (Overall summary) score, KCCQ-PL (Physical limitation) score, and KCCQ-QoL (Quality of Life) score at 24, 48, and 96 weeks
- Number of days hospitalized due to heart failure
- Change from baseline in the Japan Heart Failure Knowledge Score at 24, 48, and 96 weeks
- Change from baseline in NT-proBNP or BNP at 24, 48, and 96 weeks
- Change from baseline in ePVS (estimated plasma volume status) at 24, 48, and 96 weeks Change from 24-, 48-, and 96-week baseline in ePVS (estimated plasma volume status)
- Change from 24, 48, and 96 week baseline in this application use rate or heart failure diary entry rate
- Change from 24, 48, and 96 week baseline in systolic and diastolic blood pressure
- Change from 24, 48, and 96 week baseline in weight
- Total medical costs for heart failure treatment

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1: Age 18 years or older
2: Chronic heart failure (any cause of heart failure)
3: Stage C (with heart failure symptoms)
4: Hospitalized for heart failure or hospitalized for heart failure in the past year
5: Owner of a smartphone with internet access and the ability to install this application

Exclude criteria

1) Those who do not have access to an Internet environment or do not have a smartphone capable of installing this application
2) Those who are unable to use a smartphone due to cognitive or physical decline or disability
3) Those who have withdrawn their consent to install this application, the terms of use, and the consent form
4) Those who are deemed inappropriate for inclusion in the study by the principal investigator or subinvestigator
5) Those who are participating or are scheduled to participate in other clinical studies that may affect the treatment of chronic heart failure during participation in this study
6) Those whose heart failure symptoms are as severe as NYHA IV and require continuous inpatient care
7) Those who are scheduled to undergo cardiac surgery during participation in the study are scheduled to undergo cardiac surgery during participation in the study.

Related Information

• Primary Sponsor: Dohi Kaoru
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development,Mie Junkanki/Jinsikkan Network,Nabari City, Mie,Mie University Hospital