Shared Medical Appointment for COPD Patients (SMA-COPD)

NCT07128745 | Active Not Recruiting DMC

• 1 other identifier: 2025YLSD No. 220-01
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease, COPD

Keywords

COPD; co-design; mixed methods; cluster randomized controlled trial

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  6 months after intervention

Secondary Outcomes (7)

• Correct use of inhaled medication devices

  6 months after intervention

• Forced expiratory volume in one second, FEV1.

  6 months after intervention

• Six-minute walk test distance

  6 months after intervention

• Frequency of acute exacerbations requiring hospitalisation

  6 months after intervention

• Knowledge of COPD

  6 months after intervention

Study Arms (2)

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.

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.

Behavioral: Usual Care + Self-Management Handbook

Interventions

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.

Shared medical appointment with self-management behavior intervention strategy

Usual Care + Self-Management Handbook BEHAVIORAL

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

Usual care with self-management handbook

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (2)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Haidian District Huayuan Road Community Health Service Centre

Beijing, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Shared Medical Appointments

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Appointments and Schedules; Organization and Administration; Health Services Administration; Practice Management, Medical; Practice Management; Professional Practice

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is a single-blind study. Due to the nature of the intervention, participants, care providers, and investigators will be aware of group assignments. However, outcome assessors and data analysts will be blinded to participant group allocation to minimize the risk of bias during data evaluation and interpretation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: August 19, 2025
• Study Start: June 5, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: When the data analysis completed and the related paper published, the IPD and supporting information will be available for 3 years.
• Access Criteria: IPD and supporting documents (e.g., study protocol, statistical analysis plan) will be available to qualified researchers upon reasonable request, subject to approval by the study steering committee. Accessible Data: De-identified IPD, including demographics, clinical outcomes, and behavioral intervention records, will be shared. Access Process: Requests should be submitted via email to the corresponding author, with a detailed research proposal and ethical approval proof. Data will be transferred through secure platforms after signing a data use agreement.

Locations

CN (2)