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Developing a comprehensive SOP management information system for chronic obstructive pulmonary disease patients during the transition period from acute exacerbation to stability in primary hospitals and a multi-dimensional comprehensive evaluation of its effectiveness

Developing a comprehensive SOP management information system for chronic obstructive pulmonary disease patients during the transition period from acute exacerbation to stability in primary hospitals and a multi-dimensional comprehensive evaluation of its effectiveness

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098661
Enrollment
Unknown
Registered
2025-03-12
Start date
2025-04-15
Completion date
Unknown
Last updated
2025-03-17

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

Conditions

Chronic obstructive pulmonary disease

Interventions

Intervention group:Patients were closely followed up using the informatized SOP management system.
Control group:Usual Care

Sponsors

The First Affiliated Hospital of Kunming Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Diagnosed with COPD; (2) Hospitalized for acute exacerbation of COPD and meeting discharge criteria (the patient is deemed by the clinician to be suitable for home healthcare; the patient can use long-acting bronchodilators, ß2-agonists and/or anticholinergics, with or without inhaled corticosteroids for stable-phase inhalation therapy, with short-acting ß2-agonists used less than every 4 hours; if the patient was not previously bedridden, they must be able to walk indoors; the patient can eat, and sleep is unaffected by dyspnea; clinically stable for 12–24 hours; arterial blood gas analysis stable for 12–24 hours; the patient (or family) fully understands the correct use of stable-phase medications; follow-up and home care plans are properly arranged); (3) Age >=40 years; (4) Clinically assessed post-discharge for treatment with Budesonide/Glycopyrronium/Formoterol Inhalation Aerosol; (5) Signed informed consent; (6) Able to independently or with assistance use a smartphone for information reporting.

Exclusion criteria

Exclusion criteria: (1) Severe life-threatening comorbidities with an expected survival <=1 year: severe heart disease, severe chronic liver/kidney disease, bedridden cerebrovascular disease, malignancies, etc.; (2) Long-term corticosteroid use for pre-existing conditions (e.g., asthma, interstitial lung disease, sarcoidosis, cystic fibrosis) or conditions precluding future inhaled steroid use (e.g., active tuberculosis, uncontrolled infections); (3) Residence outside the service area of participating hospitals; (4) Participation in any other interventional study.

Design outcomes

Primary

MeasureTime frame
Moderate/severe acute exacerbation rate;All-cause readmission rate;

Secondary

MeasureTime frame
Rate of patient compliance of inhalation therapy;Correct usage rate and improvement rate of inhalation devices;COPD Assessment Test;Modified British medical research council;St George's Respiratory Questionnaire;Self-Rating Anxiety Scale;Self-Rating Depression Scale;Borg Dyspnoea Scale;Fagerstrom Test for Nicotine Dependence;Pittsburgh sleep quality index;Complete Blood Count;Arterial blood gas analysis;Pulmonary Function;Saturation of Peripheral Oxygen;Blood pressure;Heart rate;Major Adverse Cardiovascular Events;All-cause mortality;Cost of treatment;

Countries

China

Contacts

Public ContactLuo Zhuang

The First Affiliated Hospital of Kunming Medical University

skyny4511@126.com+86 182 0679 3646

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026