Chronic Obstructive Pulmonary Disease, COPDNCT07128745
Shared Medical Appointment for COPD Patients (SMA-COPD)
A study testing Shared Medical Appointment + Self-Management Strategy in people with Chronic Obstructive Pulmonary Disease, COPD, run by Peking University Third Hospital at 2 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, COPD
- What is being tested?
- Shared Medical Appointment + Self-Management Strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 2 sitesChina
- Study dates
- 5 Jun 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Haidian District Huayuan Road Community Health Service Centre
Beijing
About this study
Official title: Developing, Implementing and Evaluating of Self-management Behavior Intervention Through Shared Medical Appointment for COPD Patients (SMA-COPD): a Multi-stage Mixed Methods Research
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:
- 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?
Read more
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:
- 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.
Read the 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.
- Being tested
- Shared Medical Appointment + Self-Management Strategy, Usual Care + Self-Management Handbook
- Keywords
- COPD, co-design, mixed methods, cluster randomized controlled trial
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared Medical Appointment + Self-Management StrategyBehavioural
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 + Self-Management HandbookBehavioural
Participants receive routine one-on-one GP care plus a printed COPD self-management education handbook.
| Study group | Role | What they receive |
|---|---|---|
| Shared medical appointment with self-management behavior intervention strategy | Experimental | 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. Receives: Behavioral: Shared Medical Appointment + Self-Management Strategy |
| Usual care with self-management handbook | Active comparator | General practitioners will provide usual care to patients based on the standard consultation duration and distribute a COPD health education and behavioral guidance manual. Receives: Behavioral: Usual Care + Self-Management Handbook |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-management behaviour
COPD self-management Scale. This scale comprises five dimensions: symptoms, daily life, emotions, information, and self-efficacy, with a total of 51 items. Each item is scored using a 5-point Likert scale, where higher scores indicate better performance in the patient's self-management behaviors.
Zhang, C. H., He, G. P., Li, J. P., et al. (2011). Development and evaluation of a self-management scale for patients with chronic obstructive pulmonary disease. Chinese General Practice, 2011, 14(28), 3219-3223.
Measured: 6 months after intervention
medication adherence
Scale of Test of the Adherence to Inhalers (TAI). Meng, W. W., Cui, Y. N., Luo, L. J., et al. (2022). The TAI questionnaire consists of 10 items, all of which are scored using a 5-point Likert scale, where 1 point indicates "always" and 5 points indicates "never." The total score ranges from 10 to 50, with lower scores indicating poorer adherence to inhaled medication in patients. Reliability and validity of the Chinese version of the Inhaler Adherence Test. Chinese Journal of Tuberculosis and Respiratory Diseases, (05), 423-430.
Measured: 6 months after intervention
Quality of life of patients using SGRQ
The St George's Respiratory Questionnaire (SGRQ) is used to assess the severity of illness in patients with pulmonary diseases. It consists of 76 items (50 items in the U.S. version) divided into three domains: Symptoms, Activity, and Impacts on Daily Life. The scoring method employs a weighted average, where higher weights indicate a more severe impact on quality of life. The minimal clinically important difference (MCID) for this questionnaire is 4 points.
Measured: 6 months after intervention
Secondary outcomes (7)
Correct use of inhaled medication devices
Assessed using a 10-step inhaler technique evaluation checklist adapted from Qin Qiong et al. (2016), with each step scored as 1 point for a total of 10 points, where higher scores indicate better performance in using of inhaled medication devices.
Measured: 6 months after intervention
Forced expiratory volume in one second, FEV1.
FEV1 (Forced Expiratory Volume in the first second) is the maximum volume of air exhaled in the first second after a maximal inhalation, measured during a forced expiratory maneuver. It is one of the most critical indicators in pulmonary function testing. FEV1 is commonly used to assess the severity of lung function impairment in conditions such as bronchial asthma and chronic obstructive pulmonary disease (COPD). Additionally, it can be combined with FVC (Forced Vital Capacity, the maximum volume of air exhaled forcefully after a full inhalation) to diagnose COPD. For instance, a post-bronchodilator FEV1/FVC ratio < 70% of the predicted value confirms a diagnosis of COPD.
Measured: 6 months after intervention
Six-minute walk test distance
The 6-minute walk distance (6MWD) will be measured according to the American Thoracic Society (ATS) guidelines to evaluate functional exercise capacity in people with COPD. Greater walking distance indicates better cardiopulmonary function in patients.
Measured: 6 months after intervention
Frequency of acute exacerbations requiring hospitalisation
Number of acute exacerbations requiring hospital readmission
Measured: 6 months after intervention
Knowledge of COPD
COPD knowledge will be evaluated using the Bristol COPD Knowledge Questionnaire (BCKQ). The BCKQ assesses knowledge across 13 key domains: COPD etiology, epidemiology, symptoms, vaccination, smoking, infections, oral/inhaled corticosteroid therapy, exercise, antibiotics, and inhaled bronchodilators. Each domain contains 5 items (65 total items), with three response options per item: "True," "False," and "Don't know." Correct answers score 1 point; higher total scores indicate better COPD-related knowledge.
Measured: 6 months after intervention
Beliefs About Medicines
The beliefs about medication will be assessed using the Beliefs about Medicines Questionnaire-Specific (BMQ-Specific). The BMQ-Specific assesses medication concern beliefs and necessity beliefs, each measured by 5 items with scores ranging from 5 to 25. Higher scores indicate stronger beliefs in the respective dimension.
Measured: 6 months after intervention
Self-Efficacy
Self-efficacy will be assessed using the COPD Self-Efficacy Scale (CSES). The CSES comprises five dimensions: dyspnea management, emotional distress, physical activity, environmental/temperature factors, and safety behaviors, with a total of 31 items. Each item is rated on a 5-point Likert scale (1-5), where 1 = "not confident at all" and 5 = "very confident." Higher total scores indicate greater self-efficacy in patients during physical activities.
Measured: 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start5 Jun 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease, COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128745
- Sponsor's protocol ID
- 2025YLSD No. 220-01
- Status last verified
- Aug 2025
- First submitted
- 23 Jul 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that support the publication will be shared with the publication.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing, Implementing and Evaluating of Self-management Behavior Intervention Through Shared Medical Appointment for COPD Patients (SMA-COPD): a Multi-stage Mixed Methods Research
- ClinicalTrials.gov ID
- NCT07128745
- Acronym / sponsor ID
- 2025YLSD No. 220-01
- Keywords
- COPD, co-design, mixed methods, cluster randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shared medical appointment with self-management behavior intervention strategy | Experimental | Behavioral: Shared Medical Appointment + Self-Management StrategyShared 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. |
| Usual care with self-management handbook | Active comparator | Behavioral: Usual Care + Self-Management HandbookGeneral practitioners will provide usual care to patients based on the standard consultation duration and distribute a COPD health education and behavioral guidance manual. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shared Medical Appointment + Self-Management StrategyParticipants 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. | Behavioural | Shared medical appointment with self-management behavior intervention strategy |
| Usual Care + Self-Management HandbookParticipants receive routine one-on-one GP care plus a printed COPD self-management education handbook. | Behavioural | Usual care with self-management handbook |
Primary outcome
Self-management behaviour
Time frame: 6 months after intervention
COPD self-management Scale. This scale comprises five dimensions: symptoms, daily life, emotions, information, and self-efficacy, with a total of 51 items. Each item is scored using a 5-point Likert scale, where higher scores indicate better performance in the patient's self-management behaviors. Zhang, C. H., He, G. P., Li, J. P., et al. (2011). Development and evaluation of a self-management scale for patients with chronic obstructive pulmonary disease. Chinese General Practice, 2011, 14(28), 3219-3223.
medication adherence
Time frame: 6 months after intervention
Scale of Test of the Adherence to Inhalers (TAI). Meng, W. W., Cui, Y. N., Luo, L. J., et al. (2022). The TAI questionnaire consists of 10 items, all of which are scored using a 5-point Likert scale, where 1 point indicates "always" and 5 points indicates "never." The total score ranges from 10 to 50, with lower scores indicating poorer adherence to inhaled medication in patients. Reliability and validity of the Chinese version of the Inhaler Adherence Test. Chinese Journal of Tuberculosis and Respiratory Diseases, (05), 423-430.
Quality of life of patients using SGRQ
Time frame: 6 months after intervention
The St George's Respiratory Questionnaire (SGRQ) is used to assess the severity of illness in patients with pulmonary diseases. It consists of 76 items (50 items in the U.S. version) divided into three domains: Symptoms, Activity, and Impacts on Daily Life. The scoring method employs a weighted average, where higher weights indicate a more severe impact on quality of life. The minimal clinically important difference (MCID) for this questionnaire is 4 points.
7 secondary outcomes
Correct use of inhaled medication devices
Time frame: 6 months after intervention
Forced expiratory volume in one second, FEV1.
Time frame: 6 months after intervention
Six-minute walk test distance
Time frame: 6 months after intervention
Frequency of acute exacerbations requiring hospitalisation
Time frame: 6 months after intervention
Knowledge of COPD
Time frame: 6 months after intervention
Beliefs About Medicines
Time frame: 6 months after intervention
Self-Efficacy
Time frame: 6 months after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: Yes. The data that support the publication will be shared with the publication.
Related trials for Chronic Obstructive Pulmonary Disease, COPD
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
Recruiting
Rehabilitation in Safety-net Environments (RISE) to Improve Outcomes in Vulnerable Patients With COPD
COPD (Chronic Obstructive Pulmonary Disease)
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Study Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD) With Chronic Bronchitis
Chronic Obstructive Pulmonary Disease With Chronic Bronchitis
RecruitingPhase 4
Genetic Variation in IgG in Alpha 1 Antitrypsin Deficiency
Alpha 1-Antitrypsin, COPD
RecruitingObservational study
Characteristics and Outcomes of Patients Admitted to ICU for a Severe Acute Exacerbation of COPD.
COPD Exacerbation, ICU
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared Medical Appointment + Self-Management Strategy in people with Chronic Obstructive Pulmonary Disease, COPD, run by Peking University Third Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-management behaviour (time frame: 6 months after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.