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Completed

NCT Number: NCT07490470

Nurse-Led mHealth for Vulnerable-Phase Heart Failure

Heart failure is a serious condition where the heart cannot pump blood as well as it should. After being discharged from the hospital, patients with heart failure are at high risk for readmission, especially in the first three months. This period is called the "vulnerable phase." Standard care often involves follow-up visits, but patients may struggle to manage their health at home.

This study tested a new approach to care. The program is led by a nurse and uses a mobile health (mHealth) application on a smartphone. The app helps patients manage their health by providing daily medication reminders, tracking their weight and symptoms, and offering educational information. A team of doctors, pharmacists, and nurses work together to monitor patient data through the app. If any concerning signs appear, the team discusses the case and provides timely guidance to the patient.

The study enrolled 100 patients with heart failure. Half of them received this nurse-led, app-based program in addition to their regular follow-up care. The other half received only the regular follow-up care. We measured how well patients managed their own care, how they felt (their symptoms), and key health indicators like heart function and a blood marker called NT-proBNP. We compared the two groups after three months.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

Up to 80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(1) meeting the diagnostic criteria for heart failure according to the 2024 Chinese guidelines for heart failure diagnosis and treatment; (2) ability to participate in heart failure follow-up management at the outpatient clinic; (3) left ventricular ejection fraction ≤ 50%; (4) age ≤ 80 years; (5) proficiency in smartphone use by either the patient or their caregiver; and (6) adequate reading comprehension and verbal communication skills.

Exclusion criteria

(1) had other life-threatening conditions (e.g., malignancy, end-stage renal disease); or (2) exhibited severe physical impairment.

Treatment and study plan

Nurse-Led mHealth Multidisciplinary Management

Behavioral

The intervention group received a nurse-led, multidisciplinary program via the Cardiovascular Home Care APP, in addition to conventional follow-up care. Team: 4 physicians, 4 nurses, and APP use.

1.Pre-discharge APP training: daily tasks, report upload, online consultation. APP automatically linked to patient information upon discharge.2.Nurse-created plans: medication schedules, self-monitoring (BP/heart rate/weight/symptoms), follow-up appointments, with reminders.3.Regular tailored education via APP (trigger avoidance, risk control, sodium/fluid restriction, symptom recognition, exercise).4.Daily nurse monitoring via backend. Alerts (non-adherence ≥7 days; BP fluctuation >20%; medication intolerance; weight gain >2kg/3 days; volume overload symptoms) triggered nurse contact and multidisciplinary discussion for treatment adjustments.5.Structured telephone follow-up at week 1; additional calls as needed.6.Dynamic plan updates during clinic visits.

Routine Outpatient Follow-Up

Behavioral

Participants in the control group received conventional follow-up care. This consisted of standard outpatient clinic visits at 2 weeks, 1 month, 2 months, and 3 months after hospital discharge. The follow-up clinic was operated by a dedicated "physician-pharmacist-nurse" team. During these visits, the physician conducted clinical assessments and adjusted treatments as necessary. In the intervals between physician consultations, the pharmacist and nurse performed evaluations of disease knowledge and self-care behaviors, delivering individualized health education. Patients were provided with a health education handbook containing information about heart failure and logs for recording blood pressure, heart rate, body weight, and self-reported symptoms. They also received instruction on how to perform self-monitoring and apply the results to guide their self-care practices.

Primary outcomes

  1. Self-Care of Heart Failure Index (SCHFI) Scores

    Time frame: Baseline, Month 3

    The SCHFI consists of three subscales: (1) Self-Care Maintenance (10 items), which assesses treatment adherence and symptom monitoring using a 4-point Likert scale (1-4); (2) Self-Care Management (6 items), which evaluates symptom recognition (one item, 5-point Likert scale 0-4), symptom management (four items, 4-point Likert scale 1-4), and evaluation of management strategies (one item, 5-point Likert scale 0-4); and (3) Self-Care Confidence (6 items), which measures confidence in maintaining self-care (two items) and managing symptoms (four items) using a 4-point Likert scale (1-4). Each subscale is converted to a standardized score ranging from 0 to 100 using the formula: [(raw score - minimum score) / (maximum score - minimum score)] × 100. The total score is the sum of the three subscale scores (range 0-300), with higher scores indicating better self-care. The Chinese version has demonstrated good reliability, with Cronbach's α coefficients ranging from 0.656 to 0.869 for the sub

Secondary outcomes

  1. The Memorial Symptom Assessment Scale-Heart Failure (MSAS-HF)

    Time frame: Baseline, Month 3

    This 32-item instrument evaluates symptoms across three subscales: physical symptoms, psychological symptoms, and heart failure-specific symptoms. For each symptom, four dimensions are assessed: presence, frequency (1-4 point Likert scale), severity (1-4 point Likert scale), and distress (0-4 point Likert scale). If a symptom is not present, it is scored as "0". The total symptom score is calculated as the mean of all symptom scores, with higher scores indicating greater symptom burden. The Chinese version has shown excellent reliability, with Cronbach's α coefficients ranging from 0.807 to 0.946 for the total scale and subscales.

  2. NYHA Functional Class

    Time frame: Baseline, Month 3

    NYHA classification is a widely used clinical tool for evaluating the functional status of heart failure patients, reflecting symptom severity and limitations in physical activity.

  3. B-type natriuretic peptide (BNP)

    Time frame: Baseline, Month 3

    BNP measurement is utilized for heart failure screening, diagnosis, differential diagnosis, and assessment of disease severity and prognosis. Pre-discharge BNP levels are particularly valuable for stratifying the risk of subsequent cardiovascular events following hospital discharge.

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

A Nurse-Led, Multidisciplinary mHealth Program to Manage Heart Failure During the Vulnerable Post-Discharge Period

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Mar 24, 2026
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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