Shared Medical Appointment for COPD Patients (SMA-COPD)

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Usual Care + Self-Management Handbook: Participants receive routine one-on-one GP care plus a printed COPD self-management education handbook.

Study 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.

Eligibility

Primary outcome measure(s)

• Self-management behaviour — 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 — 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 — 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.

Trial sites (2)

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