RECRUITINGINTERVENTIONAL

Personalized Health Coaching for Patients With HF

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

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form with a clear understanding of the study's purpose and procedures. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

OTHER

Personalized health coaching program

Clinical: Pre-discharge education on HF management (e.g., symptoms, treatment, diet, medication, lifestyle) is provided with a booklet and website link. A digital scale is given. After discharge, 12-week phone coaching monitors medication adherence, weight, and sodium intake. Functional: Patients are referred to cardiac rehab for tailored exercise plans. Education on home exercise and oxygen monitoring is provided, with QR-linked videos. Coaching supports exercise adherence. Psycho-cognitive: Emotional support is based on the PERMA model. Patients with severe issues are referred to psychiatry. Post-discharge, coaching includes psychiatric appointment support and use of the 100-Day Diary for self-care and gratitude journaling. Social: Nurses foster trust and social reintegration. Referrals to community services are made as needed. Weekly calls ensure service connection and address unmet needs via social workers.

OTHER

standard care

Participants in the control group will receive standard care, including guideline-directed medical therapy, based on the latest clinical guidelines currently provided to patients with HF at the hospital, as well as HF education. HF education will be provided using a booklet that includes information on HF (definition, causes, symptoms, diagnosis, treatment, medications, and self-management), an exercise poster, a symptom log, a symptom checklist, fall prevention tips, and a dietary guide. Additionally, nutritionist consultations on HF-related diets, cardiac rehabilitation exercises, and financial support available through the social work department, if necessary, will be provided.

Locations (1)

Department of Cardiovascular Medicine, Gachon University, Gil Medical Center, Incheon,

Incheon, South Korea