Paediatric asthma control under a community management model in China: a protocol for a prospective multicentre cohort study

Abstract

IntroductionChildhood asthma is globally one of the most common respiratory disorders and accounts for more school absences and more hospitalizations than any other chronic illness. The worldwide economic burden of this disease exceeds those of HIV/AIDS and tuberculosis combined. Proper intervention and effective management is of paramount importance for the control and prognosis of paediatric asthma. Unfortunately, the rate of uncontrolled and partially controlled paediatric asthma in China is >90%. This study will use a new management model to investigate the status of asthma control and the adherence of patients to a medication protocol.MethodsThis prospective, multicentre, observational study will be conducted at 15 hospitals on children (n=800) diagnosed with asthma. Each patient will be assigned to either the nearest community hospital or Shanghai Children’s Medical Center, whichever is closer to the patient’s home, according to the decision of parents. Participants were divided into two groups: tertiary care hospital (Shanghai Children’s Medical Center) follow-up group and community hospital follow-up group. The primary outcome will be the difference in the proportion of controlled, partially controlled and uncontrolled asthma among the two groups. Secondary outcomes will be the differences in adherence rate, lung function, exacerbations, growth development, total asthma-related unscheduled visits, days absent from school and loss of working days for the patient’s caregiver. Data will be analysed on an intention-to-treat and a per-protocol basis.Ethics and disseminationEthics approval was obtained from the Institutional Review Board of Shanghai Children’s Medical Center affiliated with Shanghai Jiao Tong University of Medicine. We plan to publish the results of this study in a peer-reviewed journal article.

Reliability and validity of the Chinese version of the Test for Respiratory and Asthma Control in Kids (TRACK) in preschool children with asthma: a prospective validation study

“…The trial is registered as NCT02649803 on ClinicalTrials.gov. The study protocol has been published in BMJ Open 14…”

“…The caregivers of the preschool children with asthma in the ‘paediatric asthma control under a community management model in China’ clinical study programme who were invited and visited the study site to participate were given a concise description of the trial 14. The inclusion criteria were as follows: (1) the child was an outpatient ≤5 years of age and of either sex; (2) the child received a diagnosis of asthma based on the GINA criteria (a history of three or more times of wheezing attack per year in the absence of obvious respiratory infection; exercise-induced, laughing-induced or crying-induced wheezing or coughing; clinical improvement with 2–3 months of regular low-dose inhaled corticosteroids (ICSs) and symptom worsening after ICS cessation); (3) the child’s parent or guardian provided consent and (4) the caregiver had access to a smartphone.…”

A randomized controlled trial of a mobile application‐assisted nurse‐led model used to improve treatment outcomes in children with asthma

“…We developed a nurse‐led asthma care model similar to those reported before (Xu et al, ). Every child would be followed and monitored by a nurse in local hospitals or community healthcare centres for treatment adherence.…”

Association between family management and asthma control in children with asthma

“…The third national survey of childhood asthma showed that the prevalence of asthma was the highest in preschool children (3–5 years; 4.2%), school‐age children (6–14 years; 2.8%), and infants (0–2 years; 1.8%; Hong et al, ). Additionally, the rate of uncontrolled and partially controlled in children with asthma in China is >90% (Xu et al, ). Although increasing attention has been paid to the prevention and treatment of childhood asthma, the level of overall control remains unsatisfactory (Al‐Moamary et al, ; Kocaaslan & Akgun Kostak, ).…”