Here is the design of a clinical trial:

Official Title: Checklist Based Method for Improvement of COPD Care in Elderly in General Practice: Cluster Randomized Controlled Trial Using Electronic Health Records

Included conditions:
- Chronic Obstructive Pulmonary Disease (COPD)

Study Armgroups:
- {'label': 'control', 'type': 'NO_INTERVENTION', 'description': 'Usual care.'}
- {'label': 'Intervention 1', 'type': 'OTHER', 'description': 'COPD management checklist will be delivered at the beginning of the study.', 'interventionNames': ['Other: Intervention 1']}
- {'label': 'Intervention 2', 'type': 'OTHER', 'description': 'COPD management checklist will be delivered at the beginning of the study and repeated after 6 months.', 'interventionNames': ['Other: Intervention 2']}

Interventions:
- {'type': 'OTHER', 'name': 'Intervention 1', 'description': 'Checklist will be delivered at the beginning of the study. The educational intervention program will consist of a checklist that provides family physicians with COPD management for the elderly.', 'armGroupLabels': ['Intervention 1']}
- {'type': 'OTHER', 'name': 'Intervention 2', 'description': 'The same checklist will be delivered at the beginning of the study and repeated after 6 months.', 'armGroupLabels': ['Intervention 2']}

Primary Outcomes:
- {'measure': 'The proportion of elderly patients hospitalized with the J-44 code as a main reason for admission after interventions vs. control.', 'description': 'Variables from BIG DATA databases, such as the electronic health record (EHR) of patients from the National Health Found, associated with checklist will be used to assess hospitalization of elderly patients with the J-44 code as a main reason for admission after 1 year.', 'timeFrame': '12 months'}

Please estimate the sample size based on the assumption: 
80% power, a two-tailed alpha of 0.05, and intra-cluster correlation of 0.01. Adjustments for clustering and potential loss to follow-up are considered.
Sample size
        A minimum number of 84 GP clinics with at least 30 J-44 patients per clinic is required to provide a sufficient sample size for a three-arm cluster randomized controlled trial: 84 clusters and at least 2520 subjects are needed (28 clusters in each study arm) to detect a difference of 0.026 between mean event rates of hospitalization with ICD-10 code J-44 as the main reason for admission. This assumes a 25% reduction in total number of events after the intervention in the first arm (receiving checklist once) and 50% reduction in total number of events after the interventions in the second arm (receiving checklist twice) compared to the control group not receiving any intervention (standard care). It is also assumed the tests will have 80% power, a two-tailed alpha of 0.05, and intra-cluster correlation of 0.01.
        Data collected from electronic health records in 2016 indicate that the mean event rate of âhospitalized with ICD-10 code J-44 as the main reason for admissionâ in the control group is 0.105, and the standard deviation is 0.306. The unadjusted sample size was calculated for differences between three means for one-way ANOVA.
        To compare the individuals hospitalized with the J-44 code in the three arms after 1Â year, the difference between the mean event rates of the three groups was calculated according to Donner and Klar [16].
        A standard sample size formula was used to calculate the initial unadjusted sample size requirements, followed by appropriate adjustment for clustering by general practice according to Campbell et al. [17], with expected small clustering effect (ICCâ=â0.01) [18, 19].
        To prevent loss to follow-up among practices/participants, an enlarged overall sample size will be deemed appropriate to ensure adequate power.