Study for Evaluating feasibility of Long-term recording for telemonitoring by heart failure Patients at Home

Not Applicable

• Conditions: Heart Failure

• Registration Number: JPRN-UMIN000041695
• Lead Sponsor: Juntendo University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-10
• Study Completion: 2022-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

1. Patients with unstable angina, significant primary valvular heart disease, or severe arrhythmia (atrial fibrillation is not included in the exclusion criteria). 2. Patients with malignancy, severe respiratory disease, severe cerebrovascular disease, or end-stage renal disease. 3. Patients who are inappropriate for the study, judged by the investigators.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement compliance for the telemonitoring system, data transfer status, usability score evaluated by a questionnaire, changes in QOL, and other safety issues.

Secondary Outcome Measures

Name	Time	Method
- The effectiveness of the alert system which is designed to identify the disease deterioration in patients who had adverse events during the study period. - The group differences in measurement compliance, changes in health-related QOL, the sensitivity for identifying the deterioration, and frequency of errors of the alert system between patients with different background status.