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
            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.