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NCT Number: NCT07128745

Shared Medical Appointment for COPD Patients (SMA-COPD)

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Third Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Shared Medical Appointment + Self-Management Strategy

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 + Self-Management Handbook

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Correct use of inhaled medication devices

    Time frame: 6 months after intervention

    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.

  2. Forced expiratory volume in one second, FEV1.

    Time frame: 6 months after intervention

    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.

  3. Six-minute walk test distance

    Time frame: 6 months after intervention

    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.

  4. Frequency of acute exacerbations requiring hospitalisation

    Time frame: 6 months after intervention

    Number of acute exacerbations requiring hospital readmission

  5. Knowledge of COPD

    Time frame: 6 months after intervention

    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.

  6. Beliefs About Medicines

    Time frame: 6 months after intervention

    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.

  7. Self-Efficacy

    Time frame: 6 months after intervention

    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.

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 19, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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