Here is the design of a clinical trial:

Official Title: Task Shifting in the Care for Patients With Hand Osteoarthritis: May the First Consultation in Specialist Health Care be Performed by an Occupational Therapy Specialist?

Included conditions:
- Osteoarthritis Both Hands

Study Armgroups:
- {'label': 'Control', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients in the control group will receive their first consultation in specialist health care by a rheumatologist. Rheumatologist-led care comprises confirmation of diagnosis, information about hand osteoarthritis and symptom modifying medication, and, for some patients, Intra-articular injection of long-acting Corticosteroid. The rheumatologist may also refer participants to occupational therapy if needed.', 'interventionNames': ['Behavioral: Rheumatologist-led care.']}
- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Patients in the intervention group will receive their first consultation in specialist health care by an occupational therapy specialist. Occupational therapist-led care comprises confirmation of diagnosis, information about hand osteoarthritis and symptom modifying medication, teaching of hand exercises and ergonomic working methods, and, for some patients, provision assistive devices and orthoses/splints. The occupational therapist will refer patients to a short rheumatologist consultation if confirmation of diagnosis or intra-articular injections of long-acting Corticosteroid are needed.', 'interventionNames': ['Behavioral: Occupational therapist-led care.']}

Interventions:
- {'type': 'BEHAVIORAL', 'name': 'Rheumatologist-led care.', 'description': 'Rheumatologist-led care comprises confirmation of diagnosis, information about hand osteoarthritis and symptom modifying medication, and, for some patients, Intra-articular injection of long-acting Corticosteroid.\n\nThe rheumatologist may also refer participants to occupational therapy if needed.', 'armGroupLabels': ['Control']}
- {'type': 'BEHAVIORAL', 'name': 'Occupational therapist-led care.', 'description': 'Occupational therapist-led care comprises confirmation of diagnosis, information about hand osteoarthritis and symptom modifying medication, teaching of hand exercises and ergonomic working methods, and, for some patients, provision assistive devices and orthoses/splints. The occupational therapist will refer patients to a short rheumatologist consultation if confirmation of diagnosis or intra-articular injections of long-acting Corticosteroid are needed.', 'armGroupLabels': ['Intervention']}

Primary Outcomes:
- {'measure': 'Number of treatment responders', 'description': "Number of treatment responders will be calculated as number of OMERACT/OARSI-responders. This is a composite index that presents the results of changes after treatment in the three domains of pain, function and patient's global assessment as a single variable (responder yes/no).", 'timeFrame': 'One year'}

Please estimate the sample size based on the assumption: 
80% statistical power, a two-sided 95% confidence interval, and an estimated drop-out rate of 20%.
Sample size calculations
        The primary outcome will be number of patients classified as OMERACT/OARSI-responders after six months [38]. We have not been able to identify any study examining the effect of rheumatologist-led care for hand OA, but in a double-blind, randomized, placebo-controlled study with 70 participants, the effect of low-dose oral prednisolone in hand OA was assessed using the responder criteria [44]. A total of 20 participants (57%) in each group met the responder criteria after four weeks. However, it is likely that the percentage of responders declines over time. Based on discussions in the project group, we have conservatively estimated that the percentage of responders after six months in rheumatologist-led care will be 35%. With a non-inferiority margin set to 15%, 80% statistical power, a two-sided 95% confidence interval, and an estimated drop-out rate of 20%, we estimate that 400 patients (200 in each arm) will provide sufficient power to exclude that OT-led care is inferior to rheumatologist led care, assuming a response probability of 35% in each group.