Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Jan 8:14:e65197.
doi: 10.2196/65197.

Evaluation of a Global Initiative for Asthma Education and Implementation Program to Improve Asthma Care Quality (CARE4ALL): Protocol for a Multicenter, Single-Arm Study

Kewu Huang  1 , Wenjun Wang  1 , Ying Wang  1 , Yanming Li  2 , Xiaokai Feng  1 , Huahao Shen  3 , Chen Wang  4   5
Affiliations

Evaluation of a Global Initiative for Asthma Education and Implementation Program to Improve Asthma Care Quality (CARE4ALL): Protocol for a Multicenter, Single-Arm Study

Kewu Huang et al. JMIR Res Protoc. .

Abstract

Background: Poor symptom control and exacerbations of asthma diminish quality of life and pose a significant burden to patients and society. Implementing evidence-based management as recommended by the Global Initiative for Asthma (GINA), especially introducing inhaled corticosteroid-containing treatments, has the potential to vastly reduce exacerbations and the high burden of asthma in China. However, domestic implementation of the GINA recommendations has been unsatisfactory, especially in lower-level hospitals; thus, an enhancement to the awareness of and adherence to the GINA recommendations among Chinese physicians is needed to improve patient outcomes.

Objective: This study aims to bridge the gap between the GINA recommendations and the current clinical practice in China by demonstrating the benefits of an asthma quality improvement program (QIP).

Methods: A single-arm study will be conducted at around 30 hospitals across China to assess the impact of a specially designed asthma QIP. Approximately 1500 patients with asthma aged ≥14 years will be enrolled in participating hospitals and followed up for 48 weeks. The QIP-targeted at all pulmonologists and specialist nurses-will include an initial comprehensive training (including a pretraining questionnaire and posttraining quizzes) provided by a dedicated, qualified training team based on the GINA 2021 recommendations, followed by regular reinforcement learnings (integrated into the regular department lectures delivered by department directors), with multiple offline and online approaches (eg, an online patient management platform) provided as supportive tools. During this study, GINA implementation performance will be continuously monitored to inform necessary adjustments at the hospital level. The primary end point is change from baseline in the proportion of participants with an inhaled corticosteroid-based maintenance or reliever treatment at week 48. Secondary end points and exploratory end points include changes in clinical practice and patient outcomes such as treatment patterns, asthma control, and hospitalization rates due to exacerbations.

Results: This study has been completed, with 1500 patients enrolled and 1271 patients completing the study. The last visit of the last patient was on September 3, 2024, and the database lock was on September 28, 2024. Final analysis of data has started in October 2024.

Conclusions: The Change Asthma Clinical Practice through GINA Education and Implementation for All Patients With Asthma (CARE4ALL) study will hopefully help improve asthma management and patient outcomes in China by bridging the gap between evidence-based GINA recommendations and the current clinical practice.

Trial registration: ClinicalTrials.gov NCT05440097; https://clinicaltrials.gov/study/NCT05440097.

International registered report identifier (irrid): DERR1-10.2196/65197.

Keywords: GINA; Global Initiative for Asthma; asthma; delivery; guidelines; health care; implementation; management; quality improvement program.

PubMed Disclaimer

Conflict of interest statement

Conflicts of Interest: AstraZeneca is involved in this study design, data collection, data analysis, and preparation of this paper. The authors declare no other conflicts of interest.

Figures

Figure 1
Figure 1
Study design. GINA: Global Initiative for Asthma; QIP: quality improvement program.
Figure 2
Figure 2
Multifaceted approaches designed to facilitate GINA implementation in the QIP. GINA: Global Initiative for Asthma; ICS: inhaled corticosteroid; QIP: quality improvement program.
See this image and copyright information in PMC

References

    1. The global asthma report 2018. Global Asthma Network. 2018. [2024-12-09]. https://globalasthmareport.org/2018/index.html .
    1. Huang K, Yang T, Xu J, Yang L, Zhao J, Zhang X, Bai C, Kang J, Ran P, Shen H, Wen F, Chen Y, Sun T, Shan G, Lin Y, Xu G, Wu S, Wang C, Wang R, Shi Z, Xu Y, Ye X, Song Y, Wang Q, Zhou Y, Li W, Ding L, Wan C, Yao W, Guo Y, Xiao F, Lu Y, Peng X, Zhang B, Xiao D, Wang Z, Chen Z, Bu X, Zhang H, Zhang X, An L, Zhang S, Zhu J, Cao Z, Zhan Q, Yang Y, Liang L, Tong X, Dai H, Cao B, Wu T, Chung KF, He J, Wang C. Prevalence, risk factors, and management of asthma in China: a national cross-sectional study. Lancet. 2019 Aug 03;394(10196):407–418. doi: 10.1016/S0140-6736(19)31147-X. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)31147-X S0140-6736(19)31147-X - DOI - PubMed
    1. Reddel HK, Taylor DR, Bateman ED, Boulet L, Boushey HA, Busse WW, Casale TB, Chanez P, Enright PL, Gibson PG, de Jongste JC, Kerstjens HAM, Lazarus SC, Levy ML, O'Byrne PM, Partridge MR, Pavord ID, Sears MR, Sterk PJ, Stoloff SW, Sullivan SD, Szefler SJ, Thomas MD, Wenzel SE. An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med. 2009;180(1):59–99. doi: 10.1164/rccm.200801-060ST. https://www.atsjournals.org/doi/10.1164/rccm.200801-060ST 180/1/59 - DOI - PubMed
    1. Bateman ED, Bousquet J, Keech ML, Busse WW, Clark TJH, Pedersen SE. The correlation between asthma control and health status: the GOAL study. Eur Respir J. 2007;29(1):56–62. doi: 10.1183/09031936.00128505. http://erj.ersjournals.com/cgi/pmidlookup?view=long&pmid=17050557 09031936.00128505 - DOI - PubMed
    1. Pedersen S. From asthma severity to control: a shift in clinical practice. Prim Care Respir J. 2010;19(1):3–9. doi: 10.4104/pcrj.2009.00059. https://www.nature.com/articles/pcrj200959 pcrj-2009-05-0044 - DOI - PMC - PubMed

Publication types

Associated data