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Active, Not Recruiting

NCT Number: NCT06573580

Primary Health Management for Chronic Obstructive Pulmonary Disease

The core objective of the "Pilot Project for the Primary Health Management of Chronic Obstructive Pulmonary Disease (COPD)" is to explore a primary health management model and service standards that are suitable for COPD patients and aligned with grassroots realities. It also aims to enhance the capability of primary healthcare institutions in the prevention and management of chronic respiratory diseases. The primary outcomes are to evaluate the efficacy and cost-effectiveness of COPD Essential Public Health Services (EPHS) intervention in communities in China.

Participants are already receiving intervention B, "Usual primary health care," as part of their regular medical care under the current health policy. Researchers will compare intervention A, which is"the EPHS for COPD", with intervention B to determine if intervention A performs better in COPD management.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pulmonary Disease Chronic Disease Chronic Obstructive Pulmonary Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China-japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 35 years.
  • Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to the 2024 GOLD guidelines.
  • Post-bronchodilator FEV1(Forced Expiratory Volume in one second) predicted ≥ 30%.

Exclusion criteria

  • Inability to provide informed consent.
  • Contraindications for pulmonary function tests, including:
  • Recent myocardial infarction, stroke, or shock within the past 3 months.
  • Severe heart failure, severe arrhythmias, or unstable angina within the past 4 weeks.
  • Recent major hemoptysis within the past 4 weeks.
  • Major thoracic, abdominal, or ophthalmic surgery within the past 3 months.
  • Psychiatric disorders requiring antipsychotic medication or with a history of seizures requiring medication.
  • Cognitive impairment, including dementia or severe comprehension deficits.
  • Uncontrolled hypertension (systolic blood pressure > 200 mmHg, diastolic blood pressure > 100 mmHg).
  • Resting heart rate > 120 beats per minute.
  • Presence of aortic aneurysm.
  • Severe hyperthyroidism.
  • Pregnancy or lactation.
  • Respiratory tract infections (e.g., tuberculosis, influenza, pneumonia) within the past month.
  • Presence of pneumothorax, large pulmonary bullae not scheduled for surgery, or tympanic membrane perforation.
  • Currently participating in, or planning to participate in, any other COPD health management or clinical intervention projects during the study period.

Treatment and study plan

The essential public health service（EPHS）for COPD

Other

Each group plans to recruit 3,000 participants. For the intervention group, the community-based management includes adding COPD management-related content to the primary public health service. This includes: Providing at least four follow-ups during the project at the 3rd, 6th, 9th, and 12th months. During each follow-up, patients must complete the "COPD Patient Follow-up Questionnaire" and receive oral health education and targeted clinical advice from the general practitioner (GP). In addition, the GPs must also distribute educational booklets and materials, record symptom assessment results and acute exacerbation situations, and provide targeted clinical advice and clinical decisions to the COPD patients according to the checklist of Chinese guideline for management of COPD in primary care. At the baseline and the last follow-up, patients need to undergo a routine physical examination, pulmonary function test, and bronchodilator test at their community health centers

Primary outcomes

  1. Acute exacerbation frequency

    Time frame: 12 months

    The number of exacerbations occurred

  2. Self-rated Quality of Life

    Time frame: 12 months

    Quality of life measured by the EQ-5D-5L (EuroQol-5 Dimensions-5 Levels) questionnaire. It consists of two parts:

    Descriptive System: This includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, ranging from no problems to extreme problems.

    Visual Analog Scale (VAS): This is a scale from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state.

    Scores from the descriptive system can be combined into a single health index value, while the VAS provides an immediate self-assessment of the respondent's health status. Higher scores indicate better health-related quality of life.

Secondary outcomes

  1. Change in lung function

    Time frame: 6 months 12 months

    Decline in forced expiratory rate in one second (FEV1) before use of bronchodilator.

  2. Degree of dyspnea (daily activity)

    Time frame: 12 months

    Measured by Modified Medical Research Council (mMRC) Dyspnea Questionnaire Minimum Value: 0 (no dyspnea) Maximum Value: 4 (severe dyspnea) It specifically assesses dyspnea based on the activity level at which shortness of breath occurs, ranging from 0 to 4. A score of 4 indicates that the patient experiences dyspnea with minimal activity, representing the most severe breathlessness.

  3. Oxygen desaturation

    Time frame: 12 months

    SpO2 measured by a pulse oximeter.

Other outcomes

  1. Nicotine dependence

    Time frame: 12 months

    Measured by Fagerström Test for Nicotine Dependence (FTND); Minimum Value: 0 (no dependence); Maximum Value: 10 (high dependence); The FTND is a widely used clinical tool to assess the level of nicotine dependence. It consists of 6 questions, each with answers assigned different point values. The cumulative score determines the level of nicotine dependence. Higher cumulative scores indicate greater nicotine dependence.

  2. Healthcare expenditure for COPD

    Time frame: 12 months

    An online survey questionnaire to collect indirect and direct non-medical costs for COPD treatment, along with data obtained from the Chinese National Healthcare Security Administration (NHSA) for the direct costs of treating and managing COPD.

  3. Clinic or emergency utilization

    Time frame: 6 months

    Clinic or emergency utilization in the past six months and clinic types were collected by an online survey questionnaire and from the Chinese National Healthcare Security Administration (NHSA).

  4. Knowledge of Primary Health Care Providers

    Time frame: 12 months

    It is an online survey questionnaire designed by our team to explore the knowledge level of primary care physicians in China on COPD. The questionnaire includes components on COPD risk factors, screening, diagnosis, treatment and control, and public education.

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Official study title

Pilot Project for the Primary Health Management of Chronic Obstructive Pulmonary Disease

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 27, 2024
Registry last updated
Aug 27, 2024

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.

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