Here is the design of a clinical trial:

Official Title: Towards Implementation of an Integrated Model of Care in Long-Term Follow-Up After Allogeneic Hematopoietic SteM Cell TransplantatIon faciLitated by eHealth Technology (The SMILe Project) - An Effectiveness-implementation Science Study

Included conditions:
- Stem Cell Transplantation

Study Armgroups:
- {'label': 'Intervention group', 'type': 'OTHER', 'description': 'Intervention group (IG) patients will receive usual care plus the SMILe-ICM (see below) when they come to their planned follow-up appointments at the University Hospital Basel. Thus, while IG participants will receive the same number of follow-up appointments as CG participants (depending on their state of health), they will also receive the SMILe-ICM, i.e., tailored self-management and behavioural support delivered by the combination of totally 12 face-to-face meetings with a Care Coordinator (CC) and the SMILeApp. The personal meetings with the CC will last around 40-90 minutes. The first three of them will occur during the initial alloSCT hospitalization, and the other nine will occur in the outpatient setting, beginning with biweekly and expanding to bi-monthly intervals until one year post-alloSCT.', 'interventionNames': ['Device: SMILe-Integrated Care Model']}
- {'label': 'Control group', 'type': 'OTHER', 'description': 'see "Intervention" section', 'interventionNames': ['Other: Usual Care']}

Interventions:
- {'type': 'DEVICE', 'name': 'SMILe-Integrated Care Model', 'description': "Four self-management intervention modules will be delivered by human and technology: 1) monitoring \\& follow-up; 2) infection prevention; 3) medication adherence; 4) physical activity.\n\nHuman. A CC will provide structured and tailored self-management and behavioural support regarding all 4 modules via 12 face-to-face meetings congruent with planned clinic follow-up visits. The CC will be connected with the patients via the SMILe technology, enabling rapid responses to early signs of health deterioration.\n\nTechnology. The SMILe technology consists of the SMILeApp and SMILeCare. The latter is the interface of the monitoring component to connect the patient with the CC supporting fast recognition of symptoms and health deterioration. The SMILeApp enables to daily record a set of medical, behavioural and symptom-related data. A lexicon provides self-management and behavioural information. All data will be transferred to the clinic to be monitored, with the patient's consent, via SMILeCare.", 'armGroupLabels': ['Intervention group']}
- {'type': 'OTHER', 'name': 'Usual Care', 'description': 'The control group (CG) participants will receive usual care, which includes no specific counselling. USB outpatient appointment frequency follows a standard schedule: during the first 3 months post-alloSCT, depending on their health status, most patients (73%) return 1 to 3 times per week for follow-up at the USB outpatient clinic, where they are mainly seen by a junior or senior physician. Depending on health status and recovery, follow-up intervals extend to weekly or monthly within 1 year post-alloSCT. A research assistant (RA) will just contact CG participants for data collection. If participants raise concerns about any symptoms, the RA will encourage them to contact their physicians.', 'armGroupLabels': ['Control group']}

Primary Outcomes:
- {'measure': 'Change of re-hospitalization rate from post-alloSCT discharge up to 15 months after allogeneic stem cell transplantation', 'description': 'The number of events after the initial post-alloSCT discharge per patient', 'timeFrame': 'Data will be collected monthly via medical records during the study period, i.e., until one year post-alloSCT and for a further period of 3 months to test for a possible wane out effect.'}

Please estimate the sample size based on the assumption: 
The study assumes an α level of 0.05, a power of 80%, a small effect size, a refusal rate of 10%, and a dropout rate of 15%. The observation period is 15 months (1.25 years).
Sample size determination for aim 1
          In order to determine an appropriate patient sample size, we considered the USBâs baseline hospitalisation event rate per patient year. As exact patient year data are not available, we assumed that in any given year, each transplant patient year receives roughly 0.5 patient years of care. We based our calculations on Schenkel et al.âs [6] study, which used patient years (number of hospitalisation events per patient year (HEPPY)) as an outcome for an intervention in lung transplantation.
          The hospitalisation rate consists of two elements: the number of hospitalisations and the period (in years) over which patients are followed up. We conducted simulations using the paramtest software package [76], computing 10â²000 iterations of the chosen parameters. Based on the USBâs available data, we set the hospitalization events per patient year to 1.56. The studyâs observation period is 15âmonths (1.25âyears). We determined the minimum sample size using the inverse of the effect size in Schenkel et al. [6], i.e., 1.79 [1.31â2.43]. Following Olivier et al.âs guidance [77], we aimed for the upper bound of a small effect size. The simulation is based on a binomial distribution with a shape parameter of 4. Assuming an Î± level of 0.05, a power of 80% and an effect size of 1.79, a minimum sample size of 52 patients (26 per group) was determined. Based on a refusal rate of 10% and a 15% drop out rate, then, we will aim to recruit a total of 80 patients (40 per group). Considering that approximately 70 adults per year receive both alloSCT and follow-up at USB, recruitment will take a minimum of 16âmonths.