Personalized health coaching for hospitalized heart failure patients with frailty

Effect of Personalized Health Coaching Program in Patients With Frailty and Heart Failure

This program tests whether nurse-led personalized health coaching for hospitalized heart failure patients with frailty can improve health and reduce readmissions over 12 weeks compared with standard care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Gachon University Gil Medical Center (other)
• Locations: 1 site (Incheon)
• Trial ID: NCT07111585 on ClinicalTrials.gov

What this trial studies

This is a randomized, controlled intervention that enrolls hospitalized acute heart failure patients aged 40 and older who screen positive for frailty using Fried's phenotype and the Tilburg Frailty Indicator. Participants are randomly assigned to a 12-week nurse-led personalized health coaching program or to standard care, with coaching focused on multidimensional needs including clinical, functional, cognitive, and social domains and support during care transitions. Outcomes include hospital readmissions, functional status, quality of life, and other clinical measures over the intervention period. The program is conducted at a single tertiary medical center in Incheon, Korea.

Who should consider this trial

Good fit: Ideal candidates are hospitalized adults aged 40 or older with a cardiologist-confirmed acute heart failure diagnosis who screen positive for frailty on validated tools and can cooperate with functional assessments and provide informed consent.

Not a fit: Patients without frailty, those unable to participate in assessments because of severe cognitive impairment or terminal illness, or those not hospitalized at the study center are unlikely to benefit from or qualify for this program.

Why it matters

Potential benefit: If successful, the program could reduce rehospitalizations and improve functional status and quality of life for frail hospitalized heart failure patients.

How similar studies have performed: Prior frailty interventions in heart failure have mostly targeted physical frailty or community-dwelling patients, so randomized evidence for a hospital-based, multidimensional nurse-led coaching approach is limited and relatively novel.

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.

Where this trial is running

Incheon

• Department of Cardiovascular Medicine, Gachon University, Gil Medical Center, Incheon, — Incheon, South Korea (RECRUITING)

Study contacts

• Study coordinator: Wook-Jin Chung, MD

Conditions: Heart Failure, Frailty, Health Coaching, Telenursing, Patient Monitoring, Randomized Controlled Trial