Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06646419

Boosting Regional Integration for COP D Care Through Guided Implementation and Audit of Post Exacerbation Transition Bundle

This is a cluster randomized interventional study. Intervention is implemented at a hospital level and will change overall daily practice. 36 county level hospitals are r an domized to the intervention group or control group at the ratio of 2:1 . Total subjects is 1368 and a size of 38 per hospital .

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Anyang, China

Loading trial locations.

About this study

The intervention is composed of 3 active components: 1) education on guideline led disease knowledge and transition bundle led management pathway, 2) standardized transition bundle implementation, 3) clinical audit.

Education begins at nearly 4 weeks before first subject in and keep learning every 4 weeks.Standardized transition bundle will be implemented once the first round education is completed. Clinical audit takes up after first subject enrolled and implemented every 12 weeks.The control group will maintain the current usual care practice. Eligible patients will be recruited in both groups and will be followed up every 12 weeks for 48 weeks.

Eligible consented patients will be enrolled consecutively to minimize selection bias. In order to achieve the purpose of continuous enrollment, all patients who visit the outpatient clinic,emergency room, and hospitalized due to exacerbation of COPD will be screened, including newly diagnosed patients or those who have bee n treated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed COPD (post- bronchodilator FEV1/FVC < 0.7)
  • 40~80 years
  • CAT≥10
  • At least two moderate or at least one severe exacerbation history in past 1 year
  • Able to sign informed consent

Exclusion criteria

  • Continuous triple inhalation therapy for ≥6 months at baseline (include single inhaler and multiple inhalers)
  • Stable COPD (symptom such as cough, sputum and shortness of breath are mild or stable, clinical condition has basically returned to pre-exacerbation)
  • Comorbidities require/contraindicate long-term use of glucocorticoid treatment: asthma, interstitial lung disease, sarcoidosis, cystic fibrosis, active tuberculosis recurrent aspiration pneumonia ect.
  • Serious comorbidities threaten to life expected survival time no more than 1 year: severe heart disease, severe chronic liver, severe kidney disease, cerebrovascular disease with long-term bed rest and malignant tumours ect.
  • Not living in the healthcare area
  • Patients currently participating in any other interventional studies

Treatment and study plan

Primary outcomes

  1. Time to CID.

    Time frame: week0-week48

    To evaluate the the impact of implementation and audit of transition bundle on clinically important deterioration (CID).

Secondary outcomes

  1. Proportion of patients received long-acting maintenance inhalation with the percentage of days covered (PDC) ≥70%.

    Time frame: week 12, 24, 36 and 48

    To evaluate the the impact of implementation and audit of transition bundle on treatment compliance.

  2. Inhalation therapy consistency rate with guideline.

    Time frame: week 12, 24, 36 and 48

    To evaluate the the impact of implementation and audit of transition bundle on treatment compliance.

  3. Inhaler device compliance,measured by the score of Test of the adherence to inhalers( TAI ) questionnare.

    Time frame: week 24 and 48

    To evaluate the the impact of implementation and audit of transition bundle on treatment compliance.

  4. Correct operation rate of inhalation device.

    Time frame: week 24 and 48

    To evaluate the the impact of implementation and audit of transition bundle on treatment compliance.

  5. Patient satisfaction rate with treatment.

    Time frame: week 24 and 48

    To evaluate the the impact of implementation and audit of transition bundle on treatment satisfaction.

  6. Disease knowledge score of patients.

    Time frame: week 24 and 48

    To evaluate the the impact of implementation and audit of transition bundle on disease knowledge.

  7. Proportion of patients received different categories of long-acting maintenance inhalation.

    Time frame: week 12, 24,36 and 48

    To evaluate the the impact of implementation and audit of transition bundle on treatment pattern.

  8. Rate of moderate or severe exacerbation.

    Time frame: week 12, 24 and 48

    To evaluate the the impact of implementation and audit of transition bundle on exacerbation.

  9. Rate of severe exacerbation.

    Time frame: week 12, 24 and 48

    To evaluate the the impact of implementation and audit of transition bundle on exacerbation.

  10. Rate of cardiovascular events.

    Time frame: week 12, 24 and 48

    To evaluate the the impact of implementation and audit of transition bundle on cardiovascular events.

  11. Change of CAT score.

    Time frame: week 0 to week 48

    To evaluate the the impact of implementation and audit of transition bundle on quality of life.

  12. Percentage change of trough FEV1 and MMEF.

    Time frame: week 0 to week 48

    To evaluate the the impact of implementation and audit of transition bundle on PFT.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Boosting Regional Integration for COPD Care Through Guided Implementation and Audit of Post Exacerbation Transition Bundle: A Multicentre , Prospective, Cluster Randomization, Inteventional Clinical Study

Acronym: BRIDGE-COPD

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 17, 2024
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.