Shared Medical Appointment for COPD Patients (SMA-COPD)

NCT ID: NCT07128745

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-05
• Study Completion Date: 2027-12-31

Brief Summary

The goal of this clinical trial is to evaluate whether a behavior change intervention, delivered through a shared medical appointment (SMA) model, can improve self-management behaviors and health outcomes among community-based patients with chronic obstructive pulmonary disease (COPD). The main questions it aims to answer are:

i) Can a BCW-based intervention strategy that integrates shared medical appointments increase COPD patients' self-management behaviors? ii) Does this strategy relate to reduced acute exacerbations, slower lung function decline, and improved health-related quality of life?

Researchers will compare the shared medical appointment group and the usual care group to see if integrating SMA improves behavioral and clinical outcomes.

Participants will i) Take part in group-based shared medical appointments once every two months for a total of three sessions over six months, led by a general practitioner, involving structured medical consultation, behavioral guidance, and peer interaction.

ii) Receive behavioral intervention based on the Behavior Change Wheel (BCW) framework, targeting modifiable factors influencing self-management behaviors.

iii) Complete questionnaires and assessments at baseline and 6-month follow-up to evaluate changes in behavior, symptoms, and quality of life.

The study uses a three-stage mixed methods design:

i) Stage 1 involves longitudinal qualitative interviews and co-design with patients and clinicians to develop the intervention strategy.

ii) Stage 2 is a pilot study to test the feasibility and acceptable for up-coming cluster randomized controlled trial.

iii)Stage 3 is a cluster randomized controlled trial to evaluate the effectiveness and mechanisms of the intervention.

Detailed Description

Chronic obstructive pulmonary disease (COPD) affects nearly 100 million patients in China, with poor self-management behaviors contributing to frequent exacerbations and increased disease burden. Despite inclusion in national basic public health services, limited healthcare resources hinder effective COPD management. Shared medical appointments (SMAs) offer a promising solution by providing group-based clinical care and behavioral interventions. This study aims to develop and evaluate a behavioral intervention strategy incorporating SMAs for community-based COPD self-management.

This multi-stage mixed methods study comprises three phases. Stage 1 uses patient-provider co-design and longitudinal qualitative research methods to analyze self-management behavioral factors based on the Behavior Change Wheel theory and develop the SMA-COPD intervention. Stage 2 conducts a feasibility study to assess intervention acceptability and research procedures. Stage 3 implements a cluster randomized controlled trial across 20 community health centers, recruiting 280 COPD patients (14 per cluster, 140 per arm). The intervention group receives three monthly SMA sessions, while controls receive routine care. Primary outcomes include COPD self-management behaviors, inhaler medication adherence, and health-related quality of life. Secondary outcomes include inhaler technique, lung function, physical activity capacity, and number of acute exacerbations. Data collection occurs at baseline and 6 months post-intervention, with additional assessments at 6 months post-intervention completion. The study follows the RE-AIM framework to evaluate reach, effectiveness, adoption, implementation, and maintenance.

Conditions

Chronic Obstructive Pulmonary Disease, COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Shared medical appointment with self-management behavior intervention strategy

Shared medical appointment with self-management behavior intervention strategy. In each intervention community center, the 14 enrolled patients will be divided into two subgroups and receive shared medical appointment interventions.

Group Type: EXPERIMENTAL

Shared Medical Appointment + Self-Management Strategy

Intervention Type: BEHAVIORAL

Participants assigned to this arm will receive a self-management intervention delivered through shared medical appointments (SMAs). The SMA intervention will be conducted once every two months for a total of three sessions over six months. Each session includes structured medical consultation, health education, behavioral guidance based on the Behavior Change Wheel (BCW) framework, and facilitated peer discussion.

Usual care with self-management handbook

General practitioners will provide usual care to patients based on the standard consultation duration and distribute a COPD health education and behavioral guidance manual.

Group Type: ACTIVE_COMPARATOR

Usual Care + Self-Management Handbook

Intervention Type: BEHAVIORAL

Participants receive routine one-on-one GP care plus a printed COPD self-management education handbook.

Interventions

Shared Medical Appointment + Self-Management Strategy

Participants assigned to this arm will receive a self-management intervention delivered through shared medical appointments (SMAs). The SMA intervention will be conducted once every two months for a total of three sessions over six months. Each session includes structured medical consultation, health education, behavioral guidance based on the Behavior Change Wheel (BCW) framework, and facilitated peer discussion.

Intervention Type: BEHAVIORAL

Usual Care + Self-Management Handbook

Participants receive routine one-on-one GP care plus a printed COPD self-management education handbook.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Meets the diagnostic criteria for Chronic Obstructive Pulmonary Disease (COPD) according to the GOLD 2024 guidelines.
• Diagnosed with COPD within the past year, or has had fewer than two outpatient visits for COPD management in the past year.
• Resides in the community under the jurisdiction of the respective community health service centre.
• Aged 40 to 80 years.
• Has full cognitive and behavioural capacity and is able to clearly express personal will.
• No plans for long-term travel in the next six months.
• Has provided written informed consent and voluntarily agreed to participate in the study.

Exclusion Criteria

• Has severe complications or other serious diseases.
• Has limited physical activity due to comorbidities or complications.
• Is currently participating in another clinical trial.
• Is unsuitable for participation by the study investigators.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University Third Hospital

Beijing, Beijing Municipality, China

Haidian District Huayuan Road Community Health Service Centre

Beijing, , China

Countries

China

Other Identifiers

2025YLSD No. 220-01

Identifier Type: -

Identifier Source: org_study_id