Personalized Health Coaching for Patients With HF

NCT07111585 | Recruiting DMC

• 1 other identifier: WJC-IIT-1003
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure; Frailty; Health Coaching; Telenursing; Patient Monitoring; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• Clinical Frailty Scale (CFS)

  The CFS measures frailty using a quick assessment through brief descriptions and illustrations. The total score ranges from 1 to 9, with a score of ≥4 indicating frailty.

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

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

  The Clinical Summary Score (CSS) is calculated as the mean of the Physical Limitation Score and the Total Symptom Score from the KCCQ. The KCCQ CSS ranges from 0 to 100, where higher scores indicate better health status.

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

Secondary Outcomes (13)

• Tilburg Frailty Indicator (TFI)

  Baseline assessment, Post assessment (12 week), Final assessment (24 week)

• Frailty phenotype (FP)

  Baseline assessment, Post assessment (12 week), Final assessment (24 week)

• Frailty Idex-Laboratory (FI-laboratory)

  Baseline assessment, Post assessment (12 week), Final assessment (24 week)

• Mini-Cog

  Baseline assessment, Post assessment (12 week), Final assessment (24 week)

• Patient Health Questionnaire-9 (PHQ-9)

  Baseline assessment, Post assessment (12 week), Final assessment (24 week)

Study Arms (2)

Personalized health coaching program

EXPERIMENTAL

Other: Personalized health coaching program

standard care

OTHER

Other: standard care

Interventions

Personalized health coaching program OTHER

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.

Personalized health coaching program

standard care OTHER

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.

standard care

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Gachon University Gil Medical Center: lead

Study Sites (1)

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

Incheon, South Korea

RECRUITING

MeSH Terms

Conditions

Heart Failure; Frailty

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Wook-Jin Chung, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: August 8, 2025
• Study Start: July 3, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)