Tokyo, Aug. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062518) titled 'Evaluation of a Help-Seeking Support Program for Symptom Management in Older Patients with Heart Failure' on Aug. 7.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Osaka Metropolitan University
Condition:
Condition - heart failure
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to evaluate a help-seeking support program for older patients with heart failure by applying the program to clinical cases.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Provision of an education and counseling program by expert nurses to facilitate help-seeking among patients with heart failure.
Eligibility:
Age-lower limit - 75
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Eligible participants were patients aged 75 years or older with Stage C heart failure who were hospitalized for worsening heart failure and were expected to continue outpatient follow-up at the same institution after discharge. Patients were eligible if the attending physician determined that participation in the study would impose minimal physical and psychological burden. In addition, participants were required to have adequate cognitive function to independently decide whether to participate in the study and to understand and complete the questionnaire. All participants received an explanation of the study and provided written informed consent before enrollment.
Key exclusion criteria - Exclusion criteria were as follows: (1) patients with heart failure other than those classified as Stage C according to the ACC/AHA heart failure staging system; (2) patients who were unable to independently decide whether to participate in the study, provide written informed consent, or complete the study questionnaires; and (3) patients who were considered unlikely to complete the intervention or the study questionnaires during scheduled outpatient follow-up visits at 1 month and 3-4 months after hospital discharge.
Target Size - 8
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 01 Month 26 Day
Date of IRB - 2026 Year 06 Month 26 Day
Anticipated trial start date - 2026 Year 08 Month 01 Day
Last follow-up date - 2027 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071518
Disclaimer: Curated by HT Syndication.