RecruitingNot Applicable

Personalized Health Coaching for Patients With HF

South Korea80 participantsStarted 2025-07-03

Plain-language summary

Frailty in heart failure (HF) patients contributes to poor outcomes, emphasizing the need for effective management. In many previous studies, frailty interventions have mainly targeted physical frailty or focused community-dwelling patients, neglecting the multidimensional needs of hospitalized individuals. As a frailty for HF patients need to include clinical, functional, cognitive, and social domains, nurses must assess it holistically and provide personalized support, especially during care transitions. This study aims to evaluate the effectiveness of a nurse-led, personalized health coaching program for hospitalized HF patients with frailty through a randomized controlled trial. This 12-week intervention program targets hospitalized HF patients with frailty. After screening frailty HF patients using validated tools such as Fried's phenotype (FP), Tilburg Frailty Indicator (TFI), participants will be randomly assigned to either an intervention or control group. The intervention group will receive personalized health services, including pre-discharge education and weekly telephone coaching, addressing clinical, functional, psycho-cognitive, and social frailty domains. Psychiatric support and community integration program will be provided as needed. The control group will receive standard care. Frailty, QoL, and clinical outcomes will be measured at baseline, 12 weeks, and 24 weeks. The primary outcomes will be improvements in frailty and QoL. Frailty will be measured both multidimensional and each of the four domains of frailty for HF patients. This study will clarify the role of multidimensional personalized interventions in addressing adverse outcomes related to frailty in patients with HF, thereby providing evidence of their necessity in its management.

Who can participate

Age range40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Clinical Frailty Scale (CFS)

Timeframe: Baseline assessment, Mid assessment (6 week), Post assessment (12 week), Final assessment (24 week)

Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS)

Timeframe: Baseline assessment, Mid assessment (6 week), Post assessment (12 week), Final assessment (24 week)

Trial details

NCT IDNCT07111585

SponsorGachon University Gil Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Wook-Jin Chung, MD

82-32-460-3663 heart@gilhospital.com

View on ClinicalTrials.gov More Heart Failure trials

Plain-language summary

Who can participate

Age range40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Clinical Frailty Scale (CFS)

Timeframe: Baseline assessment, Mid assessment (6 week), Post assessment (12 week), Final assessment (24 week)

Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS)

Timeframe: Baseline assessment, Mid assessment (6 week), Post assessment (12 week), Final assessment (24 week)