Developing, Implementing and Evaluating of Self-management Behavior Intervention Through Shared Medical Appointment for COPD Patients (SMA-COPD): a Multi-stage Mixed Methods Research
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- medication adherence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Shared medical appointment with self-management behavior intervention strategy
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.
干预措施: Shared Medical Appointment + Self-Management Strategy (Behavioral)
Usual care with self-management handbook
General practitioners will provide usual care to patients based on the standard consultation duration and distribute a COPD health education and behavioral guidance manual.
干预措施: Usual Care + Self-Management Handbook (Behavioral)
结局指标
主要结局
medication adherence
时间窗: 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
时间窗: 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.
Self-management behaviour
时间窗: 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.
次要结局
- Correct use of inhaled medication devices(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)
- Forced expiratory volume in one second, FEV1.(6 months after intervention)
- Beliefs About Medicines(6 months after intervention)
- Self-Efficacy(6 months after intervention)