Nurse-Led mHealth for Vulnerable-Phase Heart Failure

March 18, 2026 updated by: YE Jing, Peking University First Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Peking University First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nurse-Led mHealth Multidisciplinary Management
Behavioral: Nurse-Led mHealth Multidisciplinary Management

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.
Active Comparator: Routine Outpatient Follow-Up
Behavioral: Routine Outpatient Follow-Up
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Month 3
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.
Baseline, Month 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.
Baseline, Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Actual)

June 27, 2024

Study Completion (Actual)

January 17, 2025

Study Registration Dates

First Submitted

March 18, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZHKY201918

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual participant data will not be made available due to privacy and ethical restrictions imposed by the institutional ethics committee. The data that support the findings of this study are available from the corresponding author upon reasonable request, subject to approval from the Ethics Committee of Peking University First Hospital.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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