Here is the design of a clinical trial:

Official Title: Study Protocol of the EMPOWER-SUSTAIN Project: A Pilot Randomised Controlled Trial of e-Health Intervention to Improve Patient Activation and Self-Management Behaviours Among Individuals With Metabolic Syndrome in Primary Care Setting

Included conditions:
- Metabolic Syndrome

Study Armgroups:
- {'label': 'The EMPOWER-SUSTAIN e-Health Intervention', 'type': 'EXPERIMENTAL', 'description': 'The EMPOWER-SUSTAIN intervention is a multifaceted chronic disease management strategies based on the Chronic Care Model (CCM) and persuasive technology (PT) theory. It consists of training physicians and patients to use the EMPOWER-SUSTAIN web-based self-management intervention mobile apps, strengthening patient-physician relationship and reinforcing the use of relevant clinical practice guidelines for management and prescribing.', 'interventionNames': ['Device: The EMPOWER-SUSTAIN e-Health Self-Management Intervention']}
- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'The control group will continue to receive usual care at the university primary care clinic. They will be given the EMPOWER-SUSTAIN Global CV Risks Self-Management Booklet©, as this is considered as usual care at the university primary care clinic. The EMPOWER-SUSTAIN web-based self-management tool will be made available to the control group at the end of the study. During the course of the study, there will be no limit to the number of clinic visits that a patient is allowed to make in either the intervention or control groups.'}

Interventions:
- {'type': 'DEVICE', 'name': 'The EMPOWER-SUSTAIN e-Health Self-Management Intervention', 'description': 'Multifaceted chronic disease management strategies involving web-based self-management intervention mobile apps based on chronic care model and persuasive technology theory to improve patient activation and self-management behaviours among patients with metabolic syndrome.', 'armGroupLabels': ['The EMPOWER-SUSTAIN e-Health Intervention']}

Primary Outcomes:
- {'measure': 'The mean change in patient activation score using the Patient Activation Measure short form Malay version (PAM 13-M) questionnaire.', 'description': "The PAM-13 consists of 13 items measuring patients' self-reported knowledge, skills and confidence for self-management. Each item is scored on a Likert scale of 1-5. The instrument reflects the 4 stages of activation in a progressing difficulty of the items: level 1 (patients believe that their role is important), level 2 (patients have confidence and knowledge to take action), level 3 (taking action) and level 4 (staying on course under stress). According to the scoring guidelines, the raw scores are transformed through natural logarithm to achieve a better expression of the relative distance between the scores. Then, items are transformed to a standardized metric ranging from 0 to 100 (0 = lower activation; 100 = highest activation). The score is calculated by summing up the raw scores and mapping up the sum onto a scale of 0-100. A higher score of PAM-13 indicates a high level of patients activation.", 'timeFrame': '6 months'}

Please estimate the sample size based on the assumption: 
The sample size calculation is based on an 80% power, a 5% level of significance, and a 20% dropout rate.
Sample size determination
        Sample size is calculated using Power and Sample Size Calculation software version 3.1.2 [84], based on the findings of a randomised controlled trial evaluating the effects of a web-based self-management intervention for adults with chronic conditions on patient activation scores, measured by the PAM-13 questionnaire [48]. In the intervention group, the mean patient activation score at baseline was 65.33, and the mean score after the intervention was 71.30 (mean difference, 5.97âÂ±â9.70; t57â=â4.683; Pâ<â0.001) [48]. In the control group, the mean patient activation score at baseline was 66.89, and the mean score at the end of the study period was 68.93 (mean difference, 2.04âÂ±â10.01; t67â=â1.677; Pâ=â0.10) [48]. Therefore, the mean difference between the two groups was 3.93.
        Based on this assumption, a sample size of 97 patients per group is sufficient to detect mean difference of Î´â=â3.93 in the patient activation score between the two groups, with a standard deviation of Ïâ=â9.70 using a two-tailed t test of difference between means with 80% power (powerâ=â0.8), 5% level of significance (Î±â=â0.05), and sample size ratio of 1:1 between the two groups (mâ=â1). After considering a drop-out rate of 20%, the sample size required is 116 patients per group, giving a total of 232 patients to be recruited for this study.