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Heart FailureCoach-FrailHFNCT07111585

Personalized Health Coaching for Patients With HF

A study testing Personalized health coaching program in people with Heart Failure and Frailty, run by Gachon University Gil Medical Center at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Heart Failure, Frailty, Health Coaching
What is being tested?
Personalized health coaching program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteSouth Korea
Study dates
3 Jul 2025to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wook-Jin Chung, MD contact

82-32-460-3663

heart@gilhospital.com

South Korea1 site, 1 recruiting
  • Department of Cardiovascular Medicine, Gachon University, Gil Medical Center, Incheon,

    Incheon

    Jihye Yoon, MSN, 82-32-460-3663, zhyeyun@gilhospital.com

    Recruiting

Other trials in South Korea

About this study

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

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.

Read the detailed description

The prevalence of heart failure (HF) is increasing worldwide, and consistently in Korea, it has more than tripled between 2002 and 2020. As a result, the hospitalization rate due to HF has increased by 1.6 times, and the age-standardized mortality rate by more than fivefold. Despite the implementation of various treatment and management strategies, hospitalizations, unplanned visits and mortality related to HF continue to rise, underscoring the urgent need for multidimensional and personalized approaches to patient care. Particularly in Korea, the prevalence of HF begins to rise in an individual's 30s, and shows a significant increase after the age of 40s, with mortality rates gradually upward among middle-aged patients. Thus, there is the need to focus on health care among patients aged 40 and over.

One of the most common and critical issues observed in patients with HF is frailty. In HF, frailty is defined as a multidimensional, dynamic, and potentially reversible condition that, although age-related, is distinct from aging, that increases susceptibility to stressors and adverse outcomes. The overall prevalence of frailty among HF patients is estimated round 44.5%, although varying among measurement tools. Patients with frailty and HF exhibit a higher risk of cardiovascular death, HF-related hospitalization, all-cause death, and all-cause hospitalization as well as a lower quality of life (QoL). Although frailty is often age-related, it is not exclusive to the elderly, making frailty assessment essential for all patients with HF. Most existing frailty assessment tools emphasize only physical aspects and fail to capture the complexity of frailty in HF patients. Therefore, it is essential to plan and evaluate patients care using a multidimensional approach encompassing clinical, functional, cognitive-psychological, and social domains, as recommended by HF associations, which may help prevent or reduce adverse clinical outcomes.

According to the research results conducted so far, the evidence that multidimensional interventions more effectively improve frailty than single-domain interventions have been consisted, and a variety of healthcare professionals have delivered collaborative interventions to improve frailty. Among theses, nurse-led multidimensional interventions for community-dwelling older adults have shown improvements in frailty, physical function, nutritional status, QoL, social support, and mental health including reduced depression. In inpatient settings, nurses might play a key role in multidisciplinary teams as skilled health professional, educators, care coordinators, patient advocates, and liaisons. Therefore, HF nurses are able to plan and implement personalized interventions tailored to patients' individual needs in a central role.

The period from hospital admission to discharge is the most appropriate time to plan transition from hospital to home and a critical window for multidisciplinary intervention with HF patients. During hospitalization, above all else patients are at a high-risk stage of HF progress and frailty, and so early identification and fast management of HF progress are crucial. But most multidimensional interventions for frailty in HF have been conducted in community-based settings with no connection from the time of hospitalization. Hospital HF nurses can closely monitor patients' frailty status, coordinate with the care team, and plan for effective care transitions post-discharge. A structured transitional care strategy can help HF patients to maintain health care management and prevent readmissions at home.

Health coaching has emerged as an effective, goal-oriented, and patient-centered approach to support post-discharge self-care and behavior modification. After discharge interventions through phone calls, home visits, outpatient visit, or remote monitoring are essential components of HF management programs. A meta-analysis found that telecoaching has a significant impact on health outcomes, improving self-care and QoL in patients with HF. One study demonstrated that a 3-month personalized coaching program significantly reduced emergency visits and 6-month readmission rates, highlighting the importance of time in effecting behavioral change. Another study indicated that while younger patients prefer mobile or text-based interventions, older adults are more inclined to use telephone coaching in combination with paper-based health summaries. Thus, telephone coaching with paper manual book might be a particularly effective intervention for older, frail HF patients.

This study aims to present a protocol for evaluating the effects of a personalized telephone-based health coaching program on frailty, health-related QoL, and clinical outcomes among older patients hospitalized with heart failure. The findings are expected to contribute to the development of a practical, nurse-led inpatient intervention model that enhances the quality of HF patient care.

Being tested
Personalized health coaching program, standard care
Medical subject headings
Heart Failure, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Personalized health coaching programOther

    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.

  • standard careOther

    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.

Study groups in NCT07111585
Study groupRoleWhat they receive
Personalized health coaching programExperimentalNot described
Receives: Other: Personalized health coaching program
standard careOtherNot described
Receives: Other: standard care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (13)
  1. Tilburg Frailty Indicator (TFI)

    The TFI was developed based on an integral conceptual model of frailty that categorizes it into 3 dimensions: physical (8 items), psychological (4 items), and social (3 items). The frailty score (maximum, 15) is determined by summing the scores of the 3 frailty domains. Frailty is identified as a score ≥5.

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

  2. Frailty phenotype (FP)

    The FP included the following 5 criteria: loss of muscular strength (grip strength), reduced gait speed, weight loss, exhaustion, and reduced physical activity. A pre-frail state is identified when a patient meets 1 or 2 of these criteria, whereas a frail state is identified when a patient meets more than 2 criteria. Specifically, grip strength was measured using a Jamar hydraulic dynamometer, the gold standard for grip strength assessment.

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

  3. Frailty Idex-Laboratory (FI-laboratory)

    The FI-Laboratory measures frailty based on routine physical assessments and blood tests based on the accumulation of deficits. Each item was scored between 0 and 1, with 0 and 1 indicating ideal health and a theoretical state of complete frailty, respectively. The total score was calculated by dividing the total number of items assessed by the sum of the deficit item scores, with higher scores reflecting increased frailty

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

  4. Mini-Cog

    The Mini-Cog, which is used to screen for cognitive issues, comprises 3 components-3-word registration, clock drawing, and 3-word recall-with a maximum score of 5. One point was assigned for each accurately recalled word (total of 3 points), whereas 2 points were assigned for accurately drawing the clock. A score of ≤2 indicates the presence of cognitive problems

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

  5. Patient Health Questionnaire-9 (PHQ-9)

    The PHQ-9 measures depression and comprises 9 items rated from 0 (not at all) to 3 (nearly every day). The maximum total score is 27, with scores of 10-19 and 20-27 indicating moderate and severe depression, respectively

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

  6. Makizako Social Frailty Index

    The Makizako Social Frailty Index measures social frailty and comprises 5 items, with 2 or more positive responses to questions indicating social frailty.

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

  7. Heart Failure Frailty Scale (HFFS)

    The HFFS is a multidimensional frailty assessment instrument that was developed specifically for patients with HF4) and comprises 4 domains. As of now, no validated cut-off score has been universally established to classify frailty status.

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

  8. Kansas City Cardiomyopathy Questionnaire

    The KCCQ comprises 23 items that quantify 7 domains-physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), QoL (3 items), and social limitations (4 items)-of health status in patients with HF. Scores range from 0 to 100, with higher scores indicating better health status and quality of life.

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

  9. Worsening Heart Failure events

    hospitalizations, emergency room visits, and unscheduled visits to outpatients' clinics

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

  10. Change in NT-proBNP Level from Baseline

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

  11. Change in New York Heart Association Functional Class from Baseline

    Assessed by the New York Heart Association (NYHA) Functional Classification, ranging from Class I to Class IV, with higher classes indicating worse functional status.

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

  12. 6-minute walk distance

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

  13. changes in muscle mass measured by impedance

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2025
  2. Study start3 Jul 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07111585
Sponsor's protocol ID
WJC-IIT-1003
Acronym
Coach-FrailHF
Status last verified
Jul 2025
First submitted
23 Jun 2025
Last updated
8 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Personalized health coaching program in people with Heart Failure and Frailty, run by Gachon University Gil Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wook-Jin Chung, MD (82-32-460-3663, heart@gilhospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Frailty Scale (CFS) (time frame: Baseline assessment, Mid assessment (6 week), Post assessment (12 week), Final assessment (24 week)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.

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