NCT07128745Active, not recruiting
Shared Medical Appointment for COPD Patients (SMA-COPD)
Developing, Implementing and Evaluating of Self-management Behavior Intervention Through Shared Medical Appointment for COPD Patients (SMA-COPD): a Multi-stage Mixed Methods Research
Source: ClinicalTrials.gov · Last updated 19 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 280 (estimated)
- First submitted
- 23 Jul 2025
- Start date
- Jun 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- Peking University Third Hospital
- Diseases
- COPD
- NCT number
- NCT07128745
What you commit to
- Study type: Interventional
- Planned participants: 280
- From Jun 2025 to the primary completion date, Dec 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Has severe complications or other serious diseases.
Other
- Has limited physical activity due to comorbidities or complications.
- Is currently participating in another clinical trial.
- Is unsuitable for participation by the study investigators.
Who the study is looking for
- 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.
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Haidian District Huayuan Road Community Health Service Centre Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.