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Search / Trial NCT07111585

Personalized Health Coaching for Patients With HF

Launched by GACHON UNIVERSITY GIL MEDICAL CENTER · Aug 7, 2025

Trial Information

Current as of November 13, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying whether a personalized health coaching program led by nurses can help patients with heart failure who are also dealing with frailty—a condition that makes people weaker and more vulnerable to health problems. Frailty in heart failure patients isn’t just about physical weakness; it also includes mental, social, and daily functioning challenges. This study focuses on people who are hospitalized with heart failure and frailty, offering support that looks at all these areas to see if it improves their overall health and quality of life.

To join the study, participants need to be 40 years or older, have been diagnosed with heart failure, and show signs of frailty based on specific tests. Those who qualify will be randomly placed into two groups: one group will receive regular care plus personalized coaching that includes education before leaving the hospital and weekly phone calls for 12 weeks to help with their health, mental well-being, and social needs. The other group will receive the usual medical care without the extra coaching. The study will check on participants’ frailty and quality of life at the start, after 12 weeks, and again at 24 weeks to see if the coaching makes a difference. This trial aims to show how personalized support can better manage frailty in heart failure patients and improve their outcomes.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Participants aged 40 years or older will be included in the study, as heart failure (HF)-related mortality and the prevalence of HF increase significantly from this age onward. Inclusion criteria requires a diagnosis of acute HF by a cardiologist and hospitalization based on the following criteria: presence of HF symptoms (e.g., breathlessness, fatigue, ankle swelling) and signs (e.g., elevated jugular venous pressure, pulmonary crackles, peripheral edema), evidence of pulmonary congestion or edema on chest X-ray, and elevated levels of BNP (≥100 pg/mL) or NT-proBNP (≥300 pg/mL). After initial screening for frailty using both the Tilburg Frailty Indicator (TFI) and Fried's Phenotype (FP), participants will be enrolled if they are classified as frail, able to cooperate with functional assessments, and willing to provide written informed consent with a clear understanding of the study's purpose and procedures.
  • Exclusion Criteria:
  • The exclusion criteria were as follows: current enrollment in other programs or planning to participate in similar programs during the intervention period; residing outside Korea and not understanding Korean; diagnosis of dementia with the Global Deterioration Scale stage of 5 or greater; inability to comprehend the study purpose and content.

About Gachon University Gil Medical Center

Gachon University Gil Medical Center is a leading healthcare institution located in South Korea, renowned for its commitment to advancing medical research and clinical excellence. As a prominent clinical trial sponsor, the center leverages its comprehensive expertise in various medical fields to facilitate innovative research initiatives aimed at improving patient outcomes. With a strong focus on collaboration, Gachon University Gil Medical Center engages in partnerships with academic institutions, industry leaders, and healthcare professionals to drive the development of groundbreaking therapies and treatment modalities. Its state-of-the-art facilities and dedicated research teams ensure rigorous adherence to ethical standards and regulatory compliance, positioning the center at the forefront of clinical research in the region.

Locations

Incheon, Korea, Republic Of

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported