An interventional study of Shared Medical Appointment + Self-Management Strategy and Usual Care + Self-Management Handbook in Chronic Obstructive Pulmonary Disease, COPD, sponsored by Peking University Third Hospital. Active, not recruiting at 2 sites in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-08-19.
Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Health services 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:
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.
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.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's planned enrollment of 280 is above the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Shared Medical Appointment + Self-Management Strategy
General practitioners will provide usual care to patients based on the standard consultation duration and distribute a COPD health education and behavioral guidance manual.
Behavioral: Usual Care + Self-Management Handbook
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.
Participants receive routine one-on-one GP care plus a printed COPD self-management education handbook.
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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months after intervention
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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months after intervention
Frequency of acute exacerbations requiring hospitalisation
Number of acute exacerbations requiring hospital readmission
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months after intervention
Plan to share: Yes — The data that support the publication will be shared with the publication.
Supporting information: Csr
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pulmonary Disease, Chronic Obstructive→
Peking University Third Hospital