Tokyo, April 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061248) titled 'The Impact of Promoting Symptom Perception with electronic Patient-Reported outcome on Clinical Outcomes in Patients with Heart Failure.: Multicenter, randomized controlled trial' on April 14.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Teikyo Heisei University

Condition: Condition - Heart Failure Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - We will conduct a randomized controlled trial to evaluate the clinical utility of promoting symptom awareness through time-course screening of heart failure-related symptoms using ePRO (electronic Patient-Reported Outcome), with standard care (which does not promote symptom awareness) serving as the control. The primary outcome measure will be an intergroup comparison of changes over time in health-related quality of life (HRQL) as measured by the KCCQ-12. Secondary endpoints include clinical prognosis (readmission rate up to 24 weeks and severity at readmission), adherence, and HRQL. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - To promote symptom awareness, participants are asked to periodically complete the Heart Failure Physical Sensation Scale. Symptom assessments using ePRO are requested once a week for the first month after discharge, and then once every two weeks for the following six months. Interventions/Control_2 - In the control group, standard care is provided without the ePRO based symptom awareness intervention used in the intervention group.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.18 years of age or older 2.Diagnosed with heart failure and currently hospitalized 3.Written consent has been obtained from the patient 4.Able to enter ePRO data via Bring Your Own Device Key exclusion criteria - 1. Has cognitive difficulties that make it hard to complete the PRO questionnaire 2. Has mental health issues that make it hard to complete the PRO questionnaire 3. Does not speak Japanese as a native language Target Size - 220

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 12 Month 22 Day Date of IRB - 2025 Year 12 Month 22 Day Anticipated trial start date - 2026 Year 04 Month 13 Day Last follow-up date - 2028 Year 08 Month 03 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069749

Disclaimer: Curated by HT Syndication.