Xishui Project for IDM of COPD and Comorbidities
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorChina-Japan Friendship Hospital
About this trial
Study Population: 4000 stable COPD patients, and among them approximately 2000 subjects with hypertension and/or type 2 diabetes complications.
Design: Cohort Study Primary Objectives: The primary objective of this study is to access the effectiveness of IDM on changes in FEV1 from baseline to the 24th week visit in patients with COPD.
Statistical Analysis: We plan to compare demographic differences between groups based on whether the data conformed to normal distribution and satisfied variance chi-square, and proposed to calculate p-values using the t-test or non-parametric test for continuous data and Person's χ² or non-parametric test for categorical data. A two-sided p-value \< 0.05 is considered statistically significant.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥40 years;
Stable COPD patients with post-bronchodilator FEV1/FVC <70% or previously diagnosed of COPD by physicians and confirmed by PFT;
With/without diabetes and/or hypertension;
Permanent resident of Xishui (not expected to leave the area within 1 year).
Disqualifiers
Suffering from severe cognitive disorders or total loss of ability of daily living.
Death.
Trial population
Adult patients diagnosed of stable COPD with/without diabetes and/or hypertension.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Integrated Disease Management
Combination productFor COPD, they are encouraged to seek further cares and manage COPD on a regular basis. For smokers, they will be given a digital health intervention based on CBT. For participants with symptoms of depression or anxiety, another digital health intervention is provided. For abnormal BMI participants, a knowledge brochure will be provided and a medical worker from the township hospital will tell the harm of abnormal BMI. For hypertension and type 2 diabetes, we will actively include them into the National Essential Public Health program.
Treatment groups
4,000 Participants
are divided into 1 treatment groupGroup A: COPD patients with comorbidities1 intervention
Trial outcomes
Primary outcomes
1
FEV1 values
FEV1 values at baseline, and at week 24 in patients with COPD and in patients with COPD without diabetes or hypertension, COPD with hypertension, COPD with diabetes, and COPD with hypertension and diabetes, respectively;
Time frame
baseline, 24 weeks2
Change from baseline in FEV1 values at week 24
Change from baseline in FEV1 values at week 24 in patients with COPD and in patients with COPD without diabetes or hypertension, COPD with hypertension, COPD with diabetes, and COPD with hypertension and diabetes, respectively;
Time frame
24 weeksSecondary outcomes
1
Actual implementation of IDM
Actual implementation of IDM (e.g. clinical visit frequency, treatment adherence, etc.,) of over all patients, and stratified by type of comorbidities.
Time frame
48 weeks2
COPD disease outcomes
COPD disease outcomes (Life expectancy/Quality of Life/exacerbation/ mortality etc.) within week 48 and stratified by type of comorbidities.
Time frame
48 weeks3
Outpatient
Definition: Clinic or emergency utilization during the study period Functional form: Count Measurement: Medical records
Time frame
48 weeks4
Hospitalization
Definition: Hospitalization during the study period (by hospital types) Functional form: Count Measurement: Medical records
Time frame
48 weeksLocations
Sponsors and contacts
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China-Japan Friendship Hospital
Lead sponsor
Peking Union Medical College
Collaborator
Heidelberg University
Collaborator
Source ClinicalTrials.gov
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