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A Prospective Randomized Controlled Trial of a Nurse-Led Comprehensive Care Model for Improving Asthma Control in Children

A Prospective Randomized Controlled Trial of a Nurse-Led Comprehensive Care Model for Improving Asthma Control in Children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125422
Enrollment
Unknown
Registered
2026-05-26
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric asthma

Interventions

Intervention group:Nurse-led comprehensive asthma management program
Control group:Routine outpatient care

Sponsors

The First Hospital of Jilin University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. The study population consisted of children with bronchial asthma who attended the study center during the study period. Eligible participants were aged 3–18 years, with no restriction on sex. The age range was determined based on considerations including the reliability of asthma diagnosis in children, the applicability of assessment scales, and the feasibility of long-term follow-up; 2. Eligible participants were required to meet currently recognized national or international diagnostic criteria for pediatric bronchial asthma and to have a confirmed diagnosis made by a pediatric respiratory specialist. Participants could be in a stable phase of the disease or have mild-to-moderate acute exacerbations that had become clinically stable after initial standardized treatment, allowing them to receive the nursing intervention and complete baseline assessments and subsequent follow-up. Enrollment was not restricted by previous or ongoing standard pharmacological treatment, and all treatment regimens were determined by the treating physicians according to clinical guidelines and the individual patient’s condition; 3. Eligible participants and their guardians were required to have the basic capacity to complete study follow-up. Guardians needed to possess adequate communication and comprehension abilities to understand the study objectives and procedures and to cooperate with nursing interventions, follow-up assessments, and the provision of relevant information during the study period. School-aged children with sufficient cognitive and communication abilities were also required, with guardian consent, to cooperate in completing the relevant assessments; 4. Before enrollment, investigators fully explained the study objectives, procedures, potential benefits and risks, as well as the rights and obligations of participants to the guardians of all eligible children. Written informed consent was obtained voluntarily from guardians after full understanding of the study. For age-appropriate children with sufficient cognitive and expressive abilities, assent or affirmative agreement was additionally obtained on the basis of guardian consent before formal enrollment in the study.

Exclusion criteria

Exclusion criteria: Participants meeting any of the following criteria were excluded from the study: 1. Children with severe underlying diseases, including but not limited to severe congenital heart disease, chronic renal insufficiency, severe hepatic dysfunction, immunodeficiency disorders, malignant tumors, or other systemic diseases that could affect survival prognosis; 2. Children with severe neurological or psychiatric disorders that could impair cognitive function or treatment compliance and therefore interfere with participation in the nursing intervention or follow-up assessments; 3. Children with other chronic respiratory diseases, such as cystic fibrosis, bronchiectasis, or primary ciliary dyskinesia, which might confound the assessment of study outcomes; 4. Children in critical condition during hospitalization who required continuous treatment in the Pediatric Intensive Care Unit (PICU) or prolonged mechanical ventilatory support; 5. Children who had previously received systematic and long-term comprehensive nursing care or specialized chronic disease management interventions that might influence the evaluation of the study intervention effects; 6. Children who planned to transfer to another hospital during the study period or were expected to be unable to complete follow-up assessments; 7. Children whose guardians refused to sign the written informed consent form or withdrew consent before study initiation.

Design outcomes

Primary

MeasureTime frame
Asthma control level;

Secondary

MeasureTime frame
Asthma self-management ability;Medication compliance;Operating norms for inhalation devices;Quality of life related to asthma;

Countries

China

Contacts

Public ContactLi Xiujie

The First Hospital of Jilin University

xiujie@jlu.edu.cn+86 188 4458 0795

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026