This is a study protocol; primary outcomes including self-management skills assessed by validated questionnaires will be evaluated comparing age-friendly implementation aid intervention versus conventional care in elderly chronic heart failure patients.
RCT (n=148)
Assessor- and analyst-blinded
Stratified block randomization by heart failure subtype and age group
No
Does the use of age-friendly implementation aids improve symptom self-management capabilities and reduce delayed medical care in elderly patients with chronic heart failure?
This study protocol outlines a randomized controlled trial to evaluate whether age-friendly implementation aids can enhance self-management skills and reduce delayed medical care in elderly patients with chronic heart failure.
Recognizing symptoms and responding appropriately can reduce emergency department visits, heart failure hospitalization rates, and all-cause mortality. However, elderly patients with chronic heart failure face greater challenges in symptom recognition due to physiological decline and multiple comorbidities, which significantly impact their prognosis. Therefore, we conducted a randomized controlled trial to evaluate the effects of an age-friendly implementation tool on elderly patients’ symptom self-management capabilities, delayed medical care rates, and emergency department visit rates, providing evidence-based guidance for optimizing health management strategies in this population. This protocol describes a parallel randomized controlled trial (RCT) in which evaluators and analysts used a blinded method to target elderly patients over 60 years of age with heart failure. The trial compared an intervention group (n = 74) with a conventional treatment group (n = 74). The primary outcomes are self-reported symptom recognition ability assessed via the Dutch Heart Failure Knowledge Questionnaire and self-care ability assessed via the European Heart Failure Self-Care Behavior Questionnaire. The secondary outcomes include quality of life (QoL) measured via the EuroQol-5D (EQ-5D) and delayed medical care rates. All these data will be collected at baseline, at discharge, at 3 months, and at 6 months to test the effectiveness of the age-friendly execution assistance tool. This study will confirm that elderly-friendly tools can effectively enhance self-management capabilities for elderly CHF patients, significantly reducing delayed medical care and emergency department visits. We anticipate that this tool, tailored to the physiological and cognitive characteristics of the elderly population, will provide evidence-based references for precision health management and interventions for elderly patients with similar chronic conditions. The Medical Ethics Committee of Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine (20250513), approved this study. All participants signed a written informed consent form prior to the baseline assessment. Once the final report of the study is completed, the results will be widely disseminated in peer-reviewed journals. The public will be informed of the study results through media reports, briefings, and other means. ChiCTR2500106241. Registered on 21 July 2025
Li et al. (Tue,) conducted a rct in Elderly patients over 60 years with chronic heart failure, primary school education or below, capable of independent basic activities of daily living, no cognitive impairment or major mental illness (n=148). Age-friendly implementation aid toolkit including visual graded symptom identification tool, paper logbook, and edema assessment mold vs. Conventional care without age-friendly implementation aids was evaluated on Self-reported symptom recognition ability (Dutch Heart Failure Knowledge Questionnaire) and self-care ability (European Heart Failure Self-Care Behavior Questionnaire). This is a study protocol; primary outcomes including self-management skills assessed by validated questionnaires will be evaluated comparing age-friendly implementation aid intervention versus conventional care in elderly chronic heart failure patients.