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Heart FailureNCT07490470

Nurse-Led mHealth for Vulnerable-Phase Heart Failure

A study testing Nurse-Led mHealth Multidisciplinary Management and Routine Outpatient Follow-Up in people with Heart Failure, run by Peking University First Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages Up to 80 years
Conditions the study is for
Heart Failure
What is being tested?
Nurse-Led mHealth Multidisciplinary Management and Routine Outpatient Follow-Up
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
1 siteChina
Study dates
1 Jun 2022to 17 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

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 Up to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

Other trials in China

About this study

Official title: 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.

Conditions
Heart Failure
Being tested
Nurse-Led mHealth Multidisciplinary Management, Routine Outpatient Follow-Up
Medical subject headings
Heart Failure

What participants receive

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

  • Nurse-Led mHealth Multidisciplinary ManagementBehavioural

    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-UpBehavioural

    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.

Study groups in NCT07490470
Study groupRoleWhat they receive
Nurse-Led mHealth Multidisciplinary ManagementExperimentalNot described
Receives: Behavioral: Nurse-Led mHealth Multidisciplinary Management
Routine Outpatient Follow-UpActive comparatorNot described
Receives: Behavioral: Routine Outpatient Follow-Up

What is being measured

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

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

    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

    Measured: Baseline, Month 3

Secondary outcomes (3)

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

    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.

    Measured: Baseline, Month 3

  2. NYHA Functional Class

    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.

    Measured: Baseline, Month 3

  3. B-type natriuretic peptide (BNP)

    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.

    Measured: Baseline, Month 3

Timeline

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

  1. First posted24 Mar 2026
  2. Study start1 Jun 2022
  3. Primary completion27 Jun 2024
  4. Study completion17 Jan 2025

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07490470
Sponsor's protocol ID
ZHKY201918
Status last verified
Mar 2026
First submitted
18 Mar 2026
Last updated
24 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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.

Publications

  • Freedman G, Watt R, Chowdhury EK, Quinlan K, Eccleston D, Driscoll A, Theuerle J, Kearney L. Nurse-Led, Remote Optimisation of Guideline-Directed Medical Therapy in Patients with Heart Failure and Reduced Ejection Fraction Across Australia. J Clin Med. 2025 Jul 30;14(15):5371. doi: 10.3390/jcm14155371.

    PubMed 40806994

  • Son YJ, Choi J, Lee HJ. Effectiveness of Nurse-Led Heart Failure Self-Care Education on Health Outcomes of Heart Failure Patients: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2020 Sep 9;17(18):6559. doi: 10.3390/ijerph17186559.

    PubMed 32916907

  • Man JP, Dijkgraaf MGW, Handoko ML, de Lange FJ, Winter MM, Schijven MP, Stienen S, Meregalli P, Kok WEM, Kuipers DI, van der Harst P, Koole MAC, Chamuleau SAJ, Schuuring MJ. Digital consults to optimize guideline-directed therapy: design of a pragmatic multicenter randomized controlled trial. ESC Heart Fail. 2024 Feb;11(1):560-569. doi: 10.1002/ehf2.14634. Epub 2023 Dec 26.

    PubMed 38146630

  • Ozden F, Sari Z, Karaman ON, Aydogmus H. The effect of video exercise-based telerehabilitation on clinical outcomes, expectation, satisfaction, and motivation in patients with chronic low back pain. Ir J Med Sci. 2022 Jun;191(3):1229-1239. doi: 10.1007/s11845-021-02727-8. Epub 2021 Aug 6.

    PubMed 34357527

  • Zheng J, Mednick T, Heidenreich PA, Sandhu AT. Pharmacist- and Nurse-Led Medical Optimization in Heart Failure: A Systematic Review and Meta-Analysis. J Card Fail. 2023 Jul;29(7):1000-1013. doi: 10.1016/j.cardfail.2023.03.012. Epub 2023 Mar 31.

    PubMed 37004867

  • Bezerra Giordan L, Tong HL, Atherton JJ, Ronto R, Chau J, Kaye D, Shaw T, Chow C, Laranjo L. The Use of Mobile Apps for Heart Failure Self-management: Systematic Review of Experimental and Qualitative Studies. JMIR Cardio. 2022 Mar 31;6(1):e33839. doi: 10.2196/33839.

    PubMed 35357311

  • Zare-Kaseb A, Emami Zeydi A, Bakhtiari-Dovvombaygi H, Nazari AM. Effects of education based on teach-back methods on self-care and quality of life of the patients with heart failure: a systematic review. BMC Cardiovasc Disord. 2024 Oct 26;24(1):591. doi: 10.1186/s12872-024-04264-5.

    PubMed 39462344

  • 郭金玉, 吕蓉, 张健, 等. 中文版Memorial心力衰竭症状评估量表的信效度评定[J]. 中华护理杂志, 2014,49(12): 1448-1452.

  • Turker E, Beduk T. Effect of an Educational Program Intervention for Caregivers of Heart Failure Patients on Patient Symptoms and Quality of Life: A Pretest-Posttest Study. West J Nurs Res. 2025 Nov;47(11):1036-1043. doi: 10.1177/01939459251359208. Epub 2025 Jul 31.

    PubMed 40742734

  • 郭金玉, 李峥, 康晓凤. 心力衰竭自我护理指数量表的汉化及信效度检测[J]. 中华护理杂志, 2012,47(07): 653-655.

  • Riegel B, Barbaranelli C, Carlson B, Sethares KA, Daus M, Moser DK, Miller J, Osokpo OH, Lee S, Brown S, Vellone E. Psychometric Testing of the Revised Self-Care of Heart Failure Index. J Cardiovasc Nurs. 2019 Mar/Apr;34(2):183-192. doi: 10.1097/JCN.0000000000000543.

    PubMed 30303894

  • Takahashi EA, Schwamm LH, Adeoye OM, Alabi O, Jahangir E, Misra S, Still CH; American Heart Association Council on Cardiovascular Radiology and Intervention, Council on Hypertension, Council on the Kidney in Cardiovascular Disease, and Stroke Council. An Overview of Telehealth in the Management of Cardiovascular Disease: A Scientific Statement From the American Heart Association. Circulation. 2022 Dec 20;146(25):e558-e568. doi: 10.1161/CIR.0000000000001107. Epub 2022 Nov 14.

    PubMed 36373541

  • Krzesinski P, Jankowska EA, Siebert J, Galas A, Piotrowicz K, Stanczyk A, Siwolowski P, Gutknecht P, Chrom P, Murawski P, Walczak A, Szalewska D, Banasiak W, Ponikowski P, Gielerak G. Effects of an outpatient intervention comprising nurse-led non-invasive assessments, telemedicine support and remote cardiologists' decisions in patients with heart failure (AMULET study): a randomised controlled trial. Eur J Heart Fail. 2022 Mar;24(3):565-577. doi: 10.1002/ejhf.2358. Epub 2021 Oct 14.

    PubMed 34617373

  • Kitsiou S, Gerber BS, Buchholz SW, Kansal MM, Sun J, Pressler SJ. Patient-Centered mHealth Intervention to Improve Self-Care in Patients With Chronic Heart Failure: Phase 1 Randomized Controlled Trial. J Med Internet Res. 2025 Jan 15;27:e55586. doi: 10.2196/55586.

    PubMed 39813671

  • Brugts JJ, Radhoe SP, Clephas PRD, Aydin D, van Gent MWF, Szymanski MK, Rienstra M, van den Heuvel MH, da Fonseca CA, Linssen GCM, Borleffs CJW, Boersma E, Asselbergs FW, Mosterd A, Brunner-La Rocca HP, de Boer RA; MONITOR-HF investigators. Remote haemodynamic monitoring of pulmonary artery pressures in patients with chronic heart failure (MONITOR-HF): a randomised clinical trial. Lancet. 2023 Jun 24;401(10394):2113-2123. doi: 10.1016/S0140-6736(23)00923-6. Epub 2023 May 20.

    PubMed 37220768

Questions about this trial

What is this clinical trial studying?

A study testing Nurse-Led mHealth Multidisciplinary Management and Routine Outpatient Follow-Up in people with Heart Failure, run by Peking University First Hospital at 1 site in China.

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: finished, as of the sponsor's last update on 24 Mar 2026. 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 China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-Care of Heart Failure Index (SCHFI) Scores (time frame: Baseline, Month 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07490470, which also lists 19 linked publications.

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 24 Mar 2026.

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