Asymptomatic chronic obstructive pulmonary disease
Conditions
Interventions
Experimental group:Integrated intervention of inhaler therapy and behaviour modification based on information technology and physician-nurse-patients management mode
Control group:Routine care
Cohort of asymptomatic COPD patients:None
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
35 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for cohort: 1.aged 35-75 years ;2.diagnosed of COPD by post spirometry test, with post-bronchodilator FEV1/FVC<0.7; 3.CAT<10 and mMRC<=1; 4. no excerbation history or only experienced one moderate exacerbation per year defined as worsening of dyspnea and/or cough, phlegm and being treated with oral antibiotics, oral or nebulised corticosteroids;5.local residents;6. willing to participate in the cohort and sign informed consent; Inclusion criteria for RCT: 1.aged 35-75 years; 2.diagnosed of COPD by post spirometry test, with post-bronchodilator FEV1/FVC<0.7 ;3.CAT<10 and mMRC<=1; 4. no excerbation history or only experienced one moderate exacerbation per year defined as worsening of dyspnea and/or cough, phlegm and being treated with oral antibiotics, oral or nebulised corticosteroids ;5. local residents ;6. willing to participate in the RCT and attend to clinics to sign informed consent and initiate interventions;
Exclusion criteria
Exclusion criteria: Exclusion criteria for cohort: 1. Pregnancy, plan to get pregnant, or during breastfeeding period;2. primary diagnosis of asthma;3. severe cognitive impairment;4. have other diseases that severely damage the lung and cause decline in lung function, such as lung cancer resection, allergic bronchopulmonary aspergillosis, interstitial lung diseases, et al;5. active lung tuberculosis or other respiratory infectious diseases;6. unable to complete spirometry test;7. being participating in other studies on inhaler therapy or behavioural interventions;8. migrating population or plan to move recently ;9. refuse or unable to sign consent for the cohort; Exclusion criteria for RCT: 1. Pregnancy, plan to get pregnant, or during breastfeeding period;2. primary diagnosis of asthma;3.severe cognitive impairment;4.have other diseases that severely damage the lung and cause decline in lung function, such as lung cancer resection, allergic bronchopulmonary aspergillosis, interstitial lung diseases, et al;5. active lung tuberculosis or other respiratory infectious diseases;6. unable to complete spirometry test;7.being participating in other studies on inhaler therapy or behavioural interventions;8. migrating population or plan to move recently;9. refuse or unable to sign consent for the cohort ;10. have experienced or being experiencing worsening of respiratory symptoms, including worsening of cough, phlegm, and/or dyspnea, and treated with oral antibiotics and/or oral/nebulised corticosteroids, or visiting emergency or being admitted to hospitals;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pre-FEV1 at 12 month from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tobacco abstinence at 12 months;Influenza or pneumonia vaccination;Worsening of airflow obstruction;Annualised rate of mild-to-moderate acute exacerbation;Proportion of education for COPD;Regular inhaler use according to guideline;Change in awareness of COPD;Proportion of breathing training;Change in post-FEV1 at 12 month from baseline; | — |
Countries
China
Contacts
Public ContactFen Dong
China-Japan Friendship Hospital
Outcome results
None listed