Actively Recruiting
Effect of Personalized Health Coaching Program in Patients With Frailty and Heart Failure
Led by Gachon University Gil Medical Center · Updated on 2025-08-08
80
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a nurse-led personalized health coaching program for hospitalized patients with heart failure (HF) who also have frailty. Frailty in HF patients includes clinical, functional, cognitive, and social difficulties and is linked to worse health outcomes. This study aims to assess if a multidimensional personalized intervention improves frailty and quality of life compared to standard care, addressing the needs of middle-aged and older adults starting from age 40. The study randomly assigns frail hospitalized HF patients to either the personalized health coaching program or standard care. The intervention includes pre-discharge education, weekly telephone coaching for 12 weeks focusing on clinical care, exercise support, emotional and psychiatric help, and social services connection. The control group receives guideline-based standard care with education, nutrition advice, cardiac rehab exercise, and social work support. Frailty and quality of life are measured at baseline, 12 weeks, and 24 weeks. Participants will undergo multiple assessments including frailty scales, cognitive and depression questionnaires, heart failure events, physical function tests, and muscle mass measurements at four timepoints over 24 weeks. Researchers will monitor medication adherence, weight, dietary intake, and social needs through coaching calls. The study aims to provide evidence on the benefits of holistic nurse-led coaching to improve clinical and quality of life outcomes in HF patients with frailty.
CONDITIONS
Brief Title
Personalized Health Coaching for Patients With HF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 40 years or older
- Diagnosed with acute heart failure by a cardiologist and hospitalized
- Presence of heart failure symptoms and signs confirmed by clinical criteria
- Evidence of pulmonary congestion or edema on chest X-ray
- Elevated BNP (≥100 pg/mL) or NT-proBNP (≥300 pg/mL) levels
- Classified as frail by Tilburg Frailty Indicator and Fried's Phenotype
- Able to cooperate with functional assessments
- Willing to provide written informed consent with clear understanding of the study
You will not qualify if you...
- Currently enrolled in other programs or planning to participate in similar programs during the intervention period
- Residing outside Korea or unable to understand Korean
- Diagnosis of dementia with Global Deterioration Scale stage 5 or greater
- Unable to comprehend the study purpose and content
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive a nurse-led personalized telephone-based health coaching program to support self-care after hospital discharge. This includes pre-discharge education on heart failure management with materials, monitoring medication adherence, weight, sodium intake, tailored exercise plans through cardiac rehab, emotional support, and social service connections.
Weekly phone coaching calls for 12 weeks
Duration - Up to 24 weeks
Participants undergo periodic assessments of frailty, quality of life, and clinical outcomes to monitor progress and evaluate the effects of the intervention.
Assessments at baseline, 6 weeks, 12 weeks, and 24 weeks
Trial Site Locations
Total: 1 location
1
Department of Cardiovascular Medicine, Gachon University, Gil Medical Center, Incheon,
Incheon, South Korea
Actively Recruiting
Research Team
W
Wook-Jin Chung, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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