Primary Health Management for Chronic Obstructive Pulmonary Disease

NCT06573580 | Active Not Recruiting DMC

• 1 other identifier: 2024-HX-59
• Study Type: interventional
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Disease; Chronic Obstructive Pulmonary Disease

Keywords

Primary Health Management; Health Economic Evaluation; Efficacy; Community-based

Outcome Measures

Primary Outcomes (2)

• Acute exacerbation frequency

  The number of exacerbations occurred

  12 months

• Self-rated Quality of Life

  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.

  12 months

Secondary Outcomes (3)

• Change in lung function

  6 months 12 months

• Degree of dyspnea (daily activity)

  12 months

• Oxygen desaturation

  12 months

Other Outcomes (4)

• Nicotine dependence

  12 months

• Healthcare expenditure for COPD

  12 months

• Clinic or emergency utilization

  6 months

Study Arms (2)

Usual primary health care for COPD

NO INTERVENTION

The essential public health primary care for COPD

EXPERIMENTAL

Other: The essential public health service（EPHS）for COPD

Interventions

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

The essential public health primary care for COPD

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Lung Diseases; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Ting Yang

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

• Chen Wang

  Chinese Academy of Medical Sciences and Peking Union Medical College

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of the National Center for Respiratory Medicine

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: August 27, 2024
• Study Start: July 4, 2024
• Primary Completion: July 31, 2025
• Study Completion: August 31, 2025
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)