Here is the design of a clinical trial:

Official Title: Global Excellence in COPD Outcomes: Implementation and Effectiveness of COPD Self-Management Action Plans in Low and Middle Income Countries

Included conditions:
- Chronic Obstructive Pulmonary Disease

Study Armgroups:
- {'label': 'Intervention Group', 'type': 'EXPERIMENTAL', 'description': 'Patient education in use of a COPD self-management action plan supported by monthly visits from, and access to, a CHW who has been trained in the use of a COPD self-management action plan.', 'interventionNames': ['Behavioral: COPD Self-Management Plan']}
- {'label': 'Control Group', 'type': 'NO_INTERVENTION', 'description': "COPD 'standard' care in local setting - Bhaktapur, Nepal; Lima, Peru; Nakaseke, Uganda"}

Interventions:
- {'type': 'BEHAVIORAL', 'name': 'COPD Self-Management Plan', 'description': 'Patient education in use of a COPD self-management action plan supported by monthly visits from, and access to, a CHW who has been trained in the use of a COPD self-management action plan.', 'armGroupLabels': ['Intervention Group']}

Primary Outcomes:
- {'measure': 'Change in SGRQ', 'description': 'Comparison of the change in SGRQ between baseline and 12 months, in the intervention compared to the control arm.\n\nb) Implementation Aim 1: Assess the appropriateness, acceptability and feasibility of using questionnaires and PEF to identify COPD cases from the perspective of local community members, community health workers, local health centre physicians and ministries of health.', 'timeFrame': '12 months'}

Please estimate the sample size based on the assumption: 
The sample size calculation is based on an 80% one-sided confidence interval that excludes a 4-point difference in SGRQ under the scenario of no difference in means.
Sample size and data analysis
          
            Sample size
            We calculated the sample size required for this trial using a confidence interval approach justified and described elsewhere [36]. This approach aims to ensure an adequate sample size to help inform a decision about continuation of GECo2 to a main trial based on an indication of a treatment effect for the primary outcome. This SGRQ score has previously been shown to have a standard deviation of 25 points in a similar population and the clinically important difference is 4 points (a recent Cochrane Review on the use of COPD Action Plans found an average decrease of 4 points in SGRQ in three randomised trials) [16]. A sample of 112 participants with COPD will be needed to produce an 80% one-sided confidence interval that excludes a 4-point difference in SGRQ under the scenario of no difference in means. We expect to have sufficient subjects to enrol 240 participants from the GECo1 study.
          
          
            Analysis
            The primary analysis will be a comparison of SGRQ scores at 12Â months between the randomised groups. We will use multiple linear regression, initially with adjustments for baseline SGRQ score and country and in subsequent analysis with adjustments for other factors including age, gender and disease severity. We will estimate the difference in means with a one-sided 80% confidence interval. We will examine repeated measurements of SGRQ by treatment group and fit random effects models to consider the effect of the intervention over time. The main analysis will be by intention-to-treat (ITT), based on cases where the primary outcome is available and will, therefore, rely on an assumption that data is missing at random. We will describe the number (%) with missing primary outcome, look at reasons for missingness and consider characteristics of the patients excluded from the ITT analysis. Models will be rerun including adjustment for factors found to be related to missingness of the 12-month score. In pre-specified exploratory analysis we will examine differences by site, and by existing vs. new diagnosis of COPD.