The Prevalence of COPD in Patients With Cardiovascular Disease and the Benefit of Cardiopulmonary Co-management (PRECEDE)

May 19, 2026 updated by: AstraZeneca

The Prevalence of COPD in Patients With Cardiovascular Disease and the Benefit of Cardiopulmonary Co-management -A Multi-center, Prospective, Interventional Study (PRECEDE)

This is a multi-center, prospective, and interventional study conducted in 3 types of cardiovascular diseases (CVD) participants , including 3 cohorts which are patients with newly or previously diagnosed coronary heart disease ( CHD), atrial fibrillation ( AF) and chronic heart failure (CHF).

Study Overview

Status

Recruiting

Conditions

Cardiovascular Diseases

Intervention / Treatment

Behavioral: Guideline education and implementation intervention

Detailed Description

The mainly purpose of this study is describe the prevalence of COPD of the participants with 3 types of CVD who are aged 40 years or older, and also observe the effect of cardiopulmonary co management on the short term prognosis of participants with CVD and COPD.

This study will enroll approximately 3,000 participants, with approximately 1,000 participants in each cohort.

Study Type

Interventional

Enrollment (Estimated)

3000

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: AstraZeneca Clinical Study Information Center
Phone Number: 1-877-240-9479
Email: information.center@astrazeneca.com

Study Locations

China
- - Anqing, China, 246004
    - Not yet recruiting
    - Research Site
  - Beijing, China, 100191
    - Recruiting
    - Research Site
  - Beijing, China, 100029
    - Recruiting
    - Research Site
  - Beijing, China, 100050
    - Not yet recruiting
    - Research Site
  - Beijing, China, 100029
    - Not yet recruiting
    - Research Site
  - Beijing, China, 100037
    - Not yet recruiting
    - Research Site
  - Changsha, China, 410005
    - Not yet recruiting
    - Research Site
  - Changsha, China, 410300
    - Recruiting
    - Research Site
  - Chaohu, China, 238001
    - Not yet recruiting
    - Research Site
  - Chengdu, China, 610041
    - Not yet recruiting
    - Research Site
  - Chengdu, China, 610072
    - Recruiting
    - Research Site
  - Chengdu, China, 610021
    - Not yet recruiting
    - Research Site
  - Chifeng, China, 024206
    - Recruiting
    - Research Site
  - Chongqing, China, 400010
    - Recruiting
    - Research Site
  - Dalian, China, 116001
    - Not yet recruiting
    - Research Site
  - Dingzhou, China, 562100
    - Not yet recruiting
    - Research Site
  - Dongguan, China, 523009
    - Not yet recruiting
    - Research Site
  - Foshan, China, CN-528000
    - Not yet recruiting
    - Research Site
  - Fuyang, China, 236400
    - Recruiting
    - Research Site
  - Fuzhou, China, 350005
    - Not yet recruiting
    - Research Site
  - Ganzhou, China, 341699
    - Not yet recruiting
    - Research Site
  - Guanghan, China, 618300
    - Not yet recruiting
    - Research Site
  - Guangzhou, China, 510280
    - Recruiting
    - Research Site
  - Guangzhou, China, 510515
    - Not yet recruiting
    - Research Site
  - Guangzhou, China, 510080
    - Not yet recruiting
    - Research Site
  - Guangzhou, China, 510100
    - Not yet recruiting
    - Research Site
  - Haikou, China, 570311
    - Recruiting
    - Research Site
  - Hangzhou, China, 310016
    - Not yet recruiting
    - Research Site
  - Hangzhou, China, 310030
    - Recruiting
    - Research Site
  - Harbin, China, 150001
    - Recruiting
    - Research Site
  - Harbin, China, 150036
    - Recruiting
    - Research Site
  - Hefei, China, 230001
    - Not yet recruiting
    - Research Site
  - Hefei, China, 230011
    - Recruiting
    - Research Site
  - Hubei, China, 434300
    - Recruiting
    - Research Site
  - Jinhua, China, 321099
    - Recruiting
    - Research Site
  - Jinzhong, China, 030600
    - Not yet recruiting
    - Research Site
  - Jiujiang, China, 332000
    - Recruiting
    - Research Site
  - Kaiyuan, China, 661600
    - Not yet recruiting
    - Research Site
  - Kunming, China, 650101
    - Not yet recruiting
    - Research Site
  - Kunming, China, 650032
    - Not yet recruiting
    - Research Site
  - Lanzhou, China, 730000
    - Recruiting
    - Research Site
  - Leping, China, 333300
    - Not yet recruiting
    - Research Site
  - Lianjiang, China, 524400
    - Not yet recruiting
    - Research Site
  - Linhai, China, 317000
    - Recruiting
    - Research Site
  - Meizhou, China, 514031
    - Recruiting
    - Research Site
  - Mianyang, China, 621000
    - Not yet recruiting
    - Research Site
  - Nanchang, China, 330006
    - Recruiting
    - Research Site
  - Neijiang, China, 641200
    - Not yet recruiting
    - Research Site
  - Ningbo, China, 315600
    - Recruiting
    - Research Site
  - Ningbo, China, 315700
    - Not yet recruiting
    - Research Site
  - Putian, China, 351106
    - Recruiting
    - Research Site
  - Quanzhou, China, 362000
    - Not yet recruiting
    - Research Site
  - Shanghai, China, 200080
    - Not yet recruiting
    - Research Site
  - Shanghai, China, 200072
    - Recruiting
    - Research Site
  - Shanghai, China, 201199
    - Not yet recruiting
    - Research Site
  - Shanghai, China, 201114
    - Recruiting
    - Research Site
  - Shanghai, China, 201318
    - Recruiting
    - Research Site
  - Shantou, China, 515041
    - Not yet recruiting
    - Research Site
  - Shantou, China, 515031
    - Not yet recruiting
    - Research Site
  - Shenyang, China, 110004
    - Not yet recruiting
    - Research Site
  - Shenzhen, China, 518036
    - Not yet recruiting
    - Research Site
  - Shijiazhuang, China, 50051
    - Recruiting
    - Research Site
  - Sichuan, China, 643200
    - Not yet recruiting
    - Research Site
  - Suining, China, 629000
    - Recruiting
    - Research Site
  - Suzhou, China, 215300
    - Recruiting
    - Research Site
  - Taiyuan, China, 030001
    - Recruiting
    - Research Site
  - Taiyuan, China, 030032
    - Not yet recruiting
    - Research Site
  - Tai’an, China, 271000
    - Recruiting
    - Research Site
  - Tianjin, China, 300211
    - Recruiting
    - Research Site
  - Tianjin, China, 300222
    - Not yet recruiting
    - Research Site
  - Tianjin, China, 300050
    - Not yet recruiting
    - Research Site
  - Tianmen, China, 431700
    - Not yet recruiting
    - Research Site
  - Wuhan, China, 430000
    - Recruiting
    - Research Site
  - Wuhan, China, 430000
    - Not yet recruiting
    - Research Site
  - Wuxi, China, 214122
    - Not yet recruiting
    - Research Site
  - Xi'an, China, 710100
    - Not yet recruiting
    - Research Site
  - Xiamen, China, 361003
    - Recruiting
    - Research Site
  - Xiangyang, China, 441000
    - Recruiting
    - Research Site
  - Xinzheng, China, 451100
    - Recruiting
    - Research Site
  - Xuzhou, China, 221009
    - Recruiting
    - Research Site
  - Yangzhou, China, 225001
    - Recruiting
    - Research Site
  - Yulin, China, 537000
    - Recruiting
    - Research Site
  - Zhangzhou, China, 363099
    - Recruiting
    - Research Site
  - Zhengzhou, China, 450000
    - Not yet recruiting
    - Research Site
  - Zunyi, China, 563100
    - Recruiting
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Give signed written informed consent to participate.
At least 40 years of age at baseline visit.
Previous or newly diagnosed by at least one of the 3 types of CVD which are,
- Coronary heart disease ( CHD )
- Atrial fibrillation (AF )
- Chronic heart failure ( CHF )
Participants can undergo spirometry testing and does not have the following serious diseases or disease states：
- Shock within the last 3 months
- Mycardial infarction, stroke or unstable angina within last 1 month
- Currently suffering from severe HF or severe arrhythmia. Severe HF refers to the need for intravenous administration of vasoactive drugs and diuretics; severe arrhythmia refers to arrhythmias that cause hemodynamic instability, such as ventricular fibrillation and ventricular tachycardia
- Severe hemoptysis or active gastrointestinal bleeding within last 1 month
- Patients with seizures requiring medication
- Patients with hypertensive crisis or uncontrolled hypertension [systolic blood pressure > 200 mmHg, diastolic blood pressure > 100 mmHg (1 mmHg = 0.133 kPa)]
- Patients with active respiratory infectious diseases or infectious diseases, such as open pulmonary tuberculosis, influenza, new coronavirus infection, and acute pneumonia
- Patients with aortic or cerebral aneurysms
- Pneumothorax and pneumothorax healing within last 1 month
- Patients with severe hyperthyroidism
- Patients who have recently had eye, ear, cranial or thoracic or abdominal surgery Note: If the patient can cooperate by completing a single, effective forced exhalation (≥6 seconds), then spirometry testing can be performed.
Subjects have the cognitive ability to conduct questionnaires after e valuated by investigators.

Exclusion Criteria:

Significant diseases or conditions, which, in the opinion of the investigator, may put the participant at risk because of participation in the study or may influence either the results of the study or the participant's ability to participate in the study.
Women who are pregnant or lactating or are planning to become pregnant, or women of childbearing potential who are not using an acceptable method of contraception.
Participant who are not able to provide written informed consent.
Treatment with investigational study drug or device in another clinical study within the last 30 days or five half lives prior to baseline visit , whichever is longer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Diagnostic
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Guideline education and implementation	Behavioral: Guideline education and implementation intervention The intervention is implemented at the investigator level and the patient level, consisted of 3 parts： Disease education Investigator level:All investigators will receive COPD and CVD disease education according to Chinese Guideline pproximately 4 weeks before the first subject is enrolled. Patient level:After the subjects are enrolled, the cardiologists and pulmonologist will provide disease education on their respective disease areas,education will be provided every 4 weeks until the end of the study. Treatment:Cardiologists and pulmonologists will work together to provide treatment management for subjects with CVD and COPD. Follow-up management:the subjects will be followed up every 4 weeks.

Participant Group / Arm

Intervention / Treatment

Other: Guideline education and implementation

Behavioral: Guideline education and implementation intervention

The intervention is implemented at the investigator level and the patient level, consisted of 3 parts：

Disease education
- Investigator level:All investigators will receive COPD and CVD disease education according to Chinese Guideline pproximately 4 weeks before the first subject is enrolled.
- Patient level:After the subjects are enrolled, the cardiologists and pulmonologist will provide disease education on their respective disease areas,education will be provided every 4 weeks until the end of the study.
Treatment:Cardiologists and pulmonologists will work together to provide treatment management for subjects with CVD and COPD.
Follow-up management:the subjects will be followed up every 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number and percentage of COPD in participants with CVD,CHD,AF,CHF. Time Frame: Baseline	To describe the prevalence of COPD in participants with CVD.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of stable COPD medications by drug class (ICS, ICS/LABA, methylxanthines,etc) and others [antibiotics, systemic corticosteroids, traditional Chinese medicine, etc]) in mono or combination at baseline and week 12. Time Frame: Baseline,week12	To describe the COPD-related treatment patterns before and after the implementation of cardiopulmonary co-management.	Baseline,week12
The hospitalization/readmission rate in participants with COPD. Time Frame: Baseline-week12	To describe the hospitalization/readmission rate in participants with COPD during the implementation of cardiopulmonary co-management.	Baseline-week12
The hospitalization/readmission rate in CHD, AF and CHF participants with COPD. Time Frame: Baseline-week12	To describe the hospitalization/readmission rate in participants with CVD during the implementation of cardiopulmonary co-management.	Baseline-week12
Change from baseline in SAQ score in participants with CHD and COPD. Time Frame: Baseline,week4,week8,week12	To describe the effects of cardiopulmonary co-management on quality of life, symptoms and activity tolerance in participants with COPD.	Baseline,week4,week8,week12
Change from baseline in AFEQT score in participants with AF and COPD. Time Frame: Baseline,week4,week8,week12	To describe the effects of cardiopulmonary co-management on quality of life, symptoms and activity tolerance in participants with COPD.	Baseline,week4,week8,week12
Change from baseline in KCCQ score in participants with CHF and COPD. Time Frame: Baseline,week4,week8,week12	To describe the effects of cardiopulmonary co-management on quality of life, symptoms and activity tolerance in participants with COPD.	Baseline,week4,week8,week12
Change from baseline in CAT score in participants with COPD. Time Frame: Baseline,week4,week8,week12	To describe the effects of cardiopulmonary co-management on quality of life, symptoms and activity tolerance in participants with COPD.	Baseline,week4,week8,week12
Change from baseline in SGRQ score in participants with COPD. Time Frame: Baseline,week4,week8,week12	To describe the effects of cardiopulmonary co-management on quality of life, symptoms and activity tolerance in participants with COPD.	Baseline,week4,week8,week12
Change from baseline in 6MWD score in participants with COPD. Time Frame: Baseline,week4,week8,week12	To describe the effects of cardiopulmonary co-management on quality of life, symptoms and activity tolerance in participants with COPD.	Baseline,week4,week8,week12
Change from baseline in pre-dose FEV1 and FVC value Time Frame: Baseline,week12	To describe the effects of cardiopulmonary co-management on lung function in participants with COPD.	Baseline,week12
Change from baseline in FEV1 and FVC value within 4 hours post-dosing. Time Frame: Baseline,week12	To describe the effects of cardiopulmonary co-management on lung function in participants with COPD.	Baseline,week12
The rate of AF recurrence in participants with AF and COPD. Time Frame: Baseline-week12	To describe the rate of AF recurrence during the period of cardiopulmonary co-management.	Baseline-week12
Change from baseline in BNP/NT-proBNP value in the participants with CHF and COPD. Time Frame: Baseline,week12	To describe the change of biomarkers in the participants with CVD and COPD during the period of cardiopulmonary co-management.	Baseline,week12
Change from baseline in blood lipids value(TC, LDL, HDL and TG) in the participants with CHD and COPD. Time Frame: Baseline,week12	To describe the change of biomarkers in the participants with CVD and COPD during the period of cardiopulmonary co-management.	Baseline,week12
Propotion of newly diagnosed COPD participants in subjects with COPD at baseline. Time Frame: Baseline	To describe the undiagnosed rate of COPD in participants with CVD.	Baseline
Propotion of newly diagnosed COPD patients in CHD, AF and CHF participants with COPD at baseline. Time Frame: Baseline	To describe the undiagnosed rate of COPD in participants with CVD.	Baseline
Propotion of participants at high risk of COPD in participants with CVD, CHD, AF and CHF at baseline. Time Frame: Baseline	To describe the proportion of participants at high risk of COPD among CVD patients.	Baseline
Propotion of participants at high risk of COPD diagnosed with COPD in participants with CVD, CHD, AF and CHF at baseline. Time Frame: Baseline	To describe the proportion of participants at high risk of COPD among CVD patients.	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The exacerbation rate in CVD, CHD, AF and CHF participants with COPD over 12 weeks. Time Frame: Baseline-week12	To explore the exacerbation rate in participants with CVD and COPD during the period of cardiopulmonary co-management.	Baseline-week12
Rate of MACE in CVD, CHD, AF and CHF participants with COPD over 12 weeks. Time Frame: Baseline-week12	To explore the occurrence of MACE event in participants with CVD and COPD during the period of cardiopulmonary co-management.	Baseline-week12
Rate of differente types of MACE in CVD, CHD, AF and CHF participants with COPD over 12 weeks. Time Frame: Baseline-week12	To explore the occurrence of MACE event in participants with CVD and COPD during the period of cardiopulmonary co-management.	Baseline-week12
Risk factors for COPD diagnosis in CHD, AF and CHF participants (analysis scope includes demographics, physiological data, family history, smoking status, age, comorbidities, lung function parameters, biomarkers, etc.) Time Frame: Baseline	To explore the risk factors in CVD participants with COPD.	Baseline
Risk factors for MACE in participants with CVD and COPD (analysis scope includes baseline characteristics, baseline PROs, drug treatment, non-drug treatment, lung function parameters, biomarkers, etc.) Time Frame: Baseline	To explore the risk factors of MACE in participants with CVD and COPD.	Baseline
Change(Mean, standard deviation, median, interquartile range, minimum, and maximum values) from baseline in pre-dose and post-dose IOS parameters(Z at 5 Hz [kPa/(L/s)]、R at 5 Hz [kPa/(L/s)]、R at 10 Hz [kPa/(L/s)] and so on) at week 12. Time Frame: Baseline,week12	To explore the changes in IOS parameters in participants with COPD during the period of cardiopulmonary co-management.	Baseline,week12
Correlation(via Spearman's rank correlation coefficient(-1 to 1), -1=negative correlation,0=no correlation, +1=positive correlation) between change from baseline in pre-dose/post-dose IOS parameters and change from baseline in CAT score at week 12. Time Frame: Baseline,week12	To explore the correlation between changes in IOS parameters and symptoms in COPD participants.	Baseline,week12
Correlation(via Spearman's rank correlation coefficient(-1 to 1), -1=negative correlation,0=no correlation, +1=positive correlation) between change from baseline in pre-dose/post-dose IOS parameters and change from baseline in mMRC score at week 12. Time Frame: Baseline,week12	To explore the correlation between changes in IOS parameters and symptoms in COPD participants.	Baseline,week12
Correlation(via Spearman's rank correlation coefficient(-1 to 1), -1=negative correlation,0=no correlation, +1=positive correlation) between change from baseline in pre/post-dose spirometry parameters and change from baseline in CAT score at week 12. Time Frame: Baseline,week12	To explore the correlation between changes in spirometry parametersH and symptoms in COPD participants.	Baseline,week12
Correlation(via Spearman's rank correlation coefficient(-1 to 1), -1=negative correlation,0=no correlation, +1=positive correlation) between change from baseline in pre/post-dose spirometry parameters and change from baseline in mMRC score at week 12. Time Frame: Baseline,week12	To explore the correlation between changes in spirometry parametersH and symptoms in COPD participants.	Baseline,week12
Area Under Curve(AUC) of oscillometry parameters for identifying COPD, along with sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) at the optimal cut-off point. Time Frame: Baseline	To analyse the diagnostic performance of oscillometry in CVD with COPD	Baseline
Correlation(via Pearson/Spearman's rank correlation coefficient(-1 to 1), -1=negative correlation,0=no correlation, +1=positive correlation) between oscillometry parameters and spirometry parameters. Time Frame: Baseline,week12	To explore the correlation between oscillometry parameters and spirometry parameters in all participants.	Baseline,week12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2025

Primary Completion (Estimated)

October 28, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 12, 2025

First Submitted That Met QC Criteria

March 27, 2025

First Posted (Actual)

April 4, 2025

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Cardiovascular Diseases

Other Study ID Numbers

D2287L00041

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. 'Yes' , indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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The Prevalence of COPD in Patients With Cardiovascular Disease and the Benefit of Cardiopulmonary Co-management (PRECEDE)

The Prevalence of COPD in Patients With Cardiovascular Disease and the Benefit of Cardiopulmonary Co-management -A Multi-center, Prospective, Interventional Study (PRECEDE)

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Other Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Cardiovascular Diseases

Clinical Trials on Guideline education and implementation intervention

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