Chronic Obstructive Pulmonary DiseaseNCT06456749
Xishui Project for IDM of COPD and Comorbidities
An observational study of Chronic Obstructive Pulmonary Disease and Comorbidities and Coexisting Conditions, run by China-Japan Friendship Hospital.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Comorbidities and Coexisting Conditions
- What is being tested?
- Integrated Disease Management
- How many people
- 4,000 participants
- Where
- No sites listed yet
- Study dates
- 17 Jun 2024to 15 Mar 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed of stable COPD with/without diabetes and/or hypertension.
Who may be able to join
- 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).
Who cannot join
- Suffering from severe cognitive disorders or total loss of ability of daily living.
- Death.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Observational, Prospective Study on the Integrated Disease Management Effectiveness of COPD and Related Comorbidities in Xishui
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.
- Being tested
- Integrated Disease Management
- Keywords
- Effectiveness of Integrated Disease Management, Multimorbidity Management, Prosepective Cohort Study
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Disease ManagementCombination product
For 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.
| Study group | Role | What they receive |
|---|---|---|
| COPD patients with comorbidities | Adult patients diagnosed of stable COPD with/without diabetes and/or hypertension.4000 stable COPD patients, and among them approximately 2000 subjects with hypertension and/or type 2 diabetes complications. Receives: Combination Product: Integrated Disease Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: baseline, 24 weeks
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;
Measured: 24 weeks
Secondary outcomes (21)
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.
Measured: 48 weeks
COPD disease outcomes
COPD disease outcomes (Life expectancy/Quality of Life/exacerbation/ mortality etc.) within week 48 and stratified by type of comorbidities.
Measured: 48 weeks
Outpatient
Definition: Clinic or emergency utilization during the study period Functional form: Count Measurement: Medical records
Measured: 48 weeks
Hospitalization
Definition: Hospitalization during the study period (by hospital types) Functional form: Count Measurement: Medical records
Measured: 48 weeks
Medical expenditure
Definition: Expenditure related to healthcare Functional form: Continuous Measurement: Medical records + additional indirect expenditures recalled from questions
Measured: 48 weeks
Quality of life (by EQ-5D-5L)
Definition: General self-rated health status Functional form: Continuous Measurement: EQ-5D instrument
Measured: 48 weeks
Blood pressure
Definition: Systolic and diastolic blood pressure (mmHg) Functional form: Continuous Measurement: Omron portable automated sphygmomanometers
Measured: 48 weeks
Waist circumference
Definition: Waist circumference (cm) Functional form: Continuous Measurement: Soft tape measure
Measured: 48 weeks
Blood Glucose
Definition: glucose level in plasma Functional form: Continuous Measurement: Blood glucose meters
Measured: 48 weeks
Body mass index
Definition: Body mass divided by the square of the body height (kg/m2) Functional form: Continuous Measurement: Calculation
Measured: 48 weeks
Smoking Status
Definition: Do you currently smoke? Functional form: Binary/Continuous Measurement: Recall question answered by individual
Measured: 48 weeks
Smoking Amount
Definition: If so, how many cigarettes do you smoke per day Functional form: Count Measurement: Recall question answered by individual
Measured: 48 weeks
Alcohol
Definition: Frequency of alcohol consumption in the past 3 months Functional form: Categorical Measurement: Recall question answered by individual
Measured: 48 weeks
Sugared consumption
Definition: Habit of sugared drink consumption Functional form: Categorical Measurement: Recall question answered by individual
Measured: 48 weeks
Fresh Vegetable Consumption
Definition: Habit of fresh vegetables consumption Functional form: Categorical Measurement: Recall question answered by individual
Measured: 48 weeks
Salted Vegetable Consumption
Definition: Habit of salted vegetable consumption Functional form: Categorical Measurement: Recall question answered by individual
Measured: 48 weeks
Physical exercise
Definition: Types of physical exercise in a typical week Functional form: Categorical Measurement: Recall question answered by individual
Measured: 48 weeks
Productivity Loss
Definition: the effect of your health problems on your ability to work and perform regular activities Functional form: Continuous Measurement: Work Productivity and Activity Impairment Questionnaire: General Health V2.0 (WPAI:GH)
Measured: 48 weeks
Household consumption expenditures
Definition: Total household annual expenditure Functional form: Continuous Measurement: A comprehensive spectrum of expenditure categories answered by household proxy respondent
Measured: 48 weeks
Working status
Definition: Main occupation and type Functional form: Categorical Measurement: Recall question answered by individual
Measured: 48 weeks
Saint George Respiratory Questionnaire Score
The overall evaluation of SGRQ score
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start17 Jun 2024 (estimated)
- Primary completion15 Oct 2025 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College, Heidelberg University
- Responsible party
- Principal investigator, Ting YANG, China-Japan Friendship Hospital
- Investigators
- Ting Yang, MD, Principal investigator, China-Japan Friendship HospitalChen Wang, MD, Study chair, Chinese Academy of Medical Sciences and Peking Union Medical CollegeSimiao Chen, PhD, Principal investigator, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456749
- Sponsor's protocol ID
- 2024-HX-22
- Status last verified
- Jun 2024
- First submitted
- 7 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Prospective Study on the Integrated Disease Management Effectiveness of COPD and Related Comorbidities in Xishui
- ClinicalTrials.gov ID
- NCT06456749
- Acronym / sponsor ID
- 2024-HX-22
- Keywords
- Effectiveness of Integrated Disease Management, Multimorbidity Management, Prosepective Cohort Study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Collaborators
- Peking Union Medical College, Heidelberg University
- Study start
- 17 Jun 2024 (estimated)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD patients with comorbidities | – | Combination Product: Integrated Disease ManagementAdult patients diagnosed of stable COPD with/without diabetes and/or hypertension.4000 stable COPD patients, and among them approximately 2000 subjects with hypertension and/or type 2 diabetes complications. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed of stable COPD with/without diabetes and/or hypertension.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (2 listed)
- Suffering from severe cognitive disorders or total loss of ability of daily living.
- Death.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Disease ManagementFor 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. | Combination product | COPD patients with comorbidities |
Primary outcome
FEV1 values
Time frame: baseline, 24 weeks
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;
Change from baseline in FEV1 values at week 24
Time frame: 24 weeks
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;
21 secondary outcomes
Actual implementation of IDM
Time frame: 48 weeks
COPD disease outcomes
Time frame: 48 weeks
Outpatient
Time frame: 48 weeks
Hospitalization
Time frame: 48 weeks
Medical expenditure
Time frame: 48 weeks
Quality of life (by EQ-5D-5L)
Time frame: 48 weeks
Blood pressure
Time frame: 48 weeks
Waist circumference
Time frame: 48 weeks
Blood Glucose
Time frame: 48 weeks
Body mass index
Time frame: 48 weeks
Smoking Status
Time frame: 48 weeks
Smoking Amount
Time frame: 48 weeks
Alcohol
Time frame: 48 weeks
Sugared consumption
Time frame: 48 weeks
Fresh Vegetable Consumption
Time frame: 48 weeks
Salted Vegetable Consumption
Time frame: 48 weeks
Physical exercise
Time frame: 48 weeks
Productivity Loss
Time frame: 48 weeks
Household consumption expenditures
Time frame: 48 weeks
Working status
Time frame: 48 weeks
Saint George Respiratory Questionnaire Score
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ting Yang, MD principal investigator
China-Japan Friendship Hospital
Chen Wang, MD study chair
Chinese Academy of Medical Sciences and Peking Union Medical College
Simiao Chen, PhD principal investigator
Chinese Academy of Medical Sciences and Peking Union Medical College
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Comorbidities and Coexisting Conditions, run by China-Japan Friendship Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ting Yang, MD (84206272, zryyyangting@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV1 values (time frame: baseline, 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.