Nurse-Led mHealth for Vulnerable-Phase Heart Failure

NCT07490470 | Completed

• 1 other identifier: ZHKY201918
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (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

  Baseline, Month 3

Secondary Outcomes (3)

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

  Baseline, Month 3

• NYHA Functional Class

  Baseline, Month 3

• B-type natriuretic peptide (BNP)

  Baseline, Month 3

Study Arms (2)

Nurse-Led mHealth Multidisciplinary Management

EXPERIMENTAL

Behavioral: Nurse-Led mHealth Multidisciplinary Management

Routine Outpatient Follow-Up

ACTIVE COMPARATOR

Behavioral: Routine Outpatient Follow-Up

Interventions

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.

Nurse-Led mHealth Multidisciplinary Management

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.

Routine Outpatient Follow-Up

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

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

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (19)

• 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.

  PMID: 40806994 RESULT

• 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.

  PMID: 32916907 RESULT

• 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.

  PMID: 38146630 RESULT

• 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.

  PMID: 34357527 RESULT

• 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.

  PMID: 37004867 RESULT

• 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.

  PMID: 35357311 RESULT

• 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.

  PMID: 39462344 RESULT

• 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.

  RESULT

• 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.

  PMID: 40742734 RESULT

• 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.

  RESULT

• 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.

  PMID: 30303894 RESULT

• 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.

  PMID: 36373541 RESULT

• 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.

  PMID: 34617373 RESULT

• 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.

  PMID: 39813671 RESULT

• 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.

  PMID: 37220768 RESULT

• Simsek E, Korkmaz Y, Bozyel S, Guler A, Kocyigit Burunkaya D, Erturk M, Keser N. Digital Technologies in Heart Failure Management. Turk Kardiyol Dern Ars. 2024 Jan;52(1):52-60. doi: 10.5543/tkda.2023.79776.

  PMID: 38221836 RESULT

• Tromp J, Bamadhaj S, Cleland JGF, Angermann CE, Dahlstrom U, Ouwerkerk W, Tay WT, Dickstein K, Ertl G, Hassanein M, Perrone SV, Ghadanfar M, Schweizer A, Obergfell A, Lam CSP, Filippatos G, Collins SP. Post-discharge prognosis of patients admitted to hospital for heart failure by world region, and national level of income and income disparity (REPORT-HF): a cohort study. Lancet Glob Health. 2020 Mar;8(3):e411-e422. doi: 10.1016/S2214-109X(20)30004-8.

  PMID: 32087174 RESULT

• Liu, H. M., Zhang, L. H.. Clinical characteristics, management, and outcome disparities of hospitalized patients with acute heart failure across different regions in China. Chin Circ J, 2024,39(6): 592-598.

  RESULT

• Chinese Society of Cardiology of Chinese Medical Association, Chinese College of Cardiovascular Physicians, Chinese Heart Failure Association of Chinese Medical Association, et al. Chinese guidelines for the diagnosis and treatment of heart failure 2024. Chin J Cardiol. 2024;52(3):235-275.

  RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Nurse

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: June 1, 2022
• Primary Completion: June 27, 2024
• Study Completion: January 17, 2025
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

CN (1)