Systemic autoimmune and chronic inflammatory diseases are a group of chronic illnesses whose treatment is usually very prolonged, often lifelong, and is essential to keep the disease under control, thus reducing the risk of complications and allowing the best possible quality of life for patients. The drugs used for treating these diseases are mostly immunosuppressants, which reduce the activity of the immune system, whose alteration is responsible for the disease. Although all available drugs are effective for treating these diseases, for reasons largely unknown, each drug is effective only in a percentage of patients. As a result, it is often necessary to try several different treatments before identifying an effective one for the individual patient. The therapeutic effects are often slow, and it is therefore necessary to take a treatment for weeks or months before its effectiveness can be determined. The initial period is also when side effects most often appear. The aim of this study is to evaluate whether the addition of remote monitoring visits and other patient support services to traditional periodic medical visits in the first months after the introduction of a new treatment leads to an improvement in adherence, response, and quality of life for the patient.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
190
Follow-up at outpatient clinic at 3 and 6 months from drug prescription Two remote consultations at 15 and 45 days from drug prescription
Follow-up at outpatient clinic at 3 and 6 months from drug prescription.
Rheumatology Unit - Perugia Univeristy Hospital
Perugia, PG, Italy
RECRUITINGTreatment persistence
Percentage of patients taking the same medication prescribed at baseline
Time frame: 6 months
Treatment Persistence
Percentage of patients taking the same medication prescribed at baseline
Time frame: 3 months
Disease activity score on 28 joints with C-Reactive Protein (DAS28-CRP)
Only applies to rheumatoid arthritis patients
Time frame: 3 months
Disease activity score on 28 joints with C-Reactive Protein (DAS28-CRP)
Only applies to rheumatoid arthritis patients
Time frame: 6 months
Psoriatic Arthritis Disease Activity Score (PASDAS)
Only applies to psoriatic arthritis patients
Time frame: 3 months
Psoriatic Arthritis Disease Activity Score (PASDAS)
Only applies to psoriatic arthritis patients
Time frame: 6 months
Body Surface Area (BSA)
Percentage of skin surface with psoriatic lesions. Only applies to psoriatic arthritis patients
Time frame: 3 months
Body Surface Area (BSA)
Percentage of skin surface with psoriatic lesions. Only applies to psoriatic arthritis patients
Time frame: 6 months
Minimal Disease Activity (MDA)
Binary outcome. Only applies to psoriatic arthritis patients
Time frame: 3 months
Minimal Disease Activity (MDA)
Binary outcome. Only applies to psoriatic arthritis patients
Time frame: 6 months
Modified Rodnan's skin score
Only applies to systemic sclerosis patients
Time frame: 3 months
Modified Rodnan's skin score
Only applies to systemic sclerosis patients
Time frame: 6 months
Medical Research Council (MRC) dyspnoea scale
Only applies to systemic sclerosis patients with interstitial lung disease
Time frame: 3 months
Medical Research Council (MRC) dyspnoea scale
Only applies to systemic sclerosis patients with interstitial lung disease
Time frame: 6 months
EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)
Only applies to Sjogren's disease patients
Time frame: 3 months
EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)
Only applies to Sjogren's disease patients
Time frame: 6 months
EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)
Only applies to Sjogren's disease patients
Time frame: 3 months
EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)
Only applies to Sjogren's disease patients
Time frame: 6 months
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K
Only applies to systemic lupus erythematosus patients
Time frame: 3 months
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K
Only applies to systemic lupus erythematosus patients
Time frame: 6 months
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Only applies to ankylosing spondylitis and axial spondyloarthritis patients
Time frame: 3 months
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Only applies to ankylosing spondylitis and axial spondyloarthritis patients
Time frame: 6 months
Health Assessment Questionnaire Disability Index (HAQ-DI)
Range 0 (best condition) - 3 (worst condition)
Time frame: 3 months
Health Assessment Questionnaire Disability Index (HAQ-DI)
Range 0 (best condition) - 3 (worst condition)
Time frame: 6 months
Anxiety and Depression
Hospital Anxiety and Depression Scale - Anxiety and Depression range 0 - 21 each (higher values mean higher degrees of depression or anxiety)
Time frame: 3 months
Anxiety and Depression
Hospital Anxiety and Depression Scale - Anxiety and Depression range 0 - 21 each (higher values mean higher degrees of depression or anxiety)
Time frame: 6 months
EQ-5D-5L score
The score measures quality of life and includes 5 domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each of which is scored from 1 (perfect health) to 5 (complete inability).
Time frame: 3 months
EQ-5D-5L score
The score measures quality of life and includes 5 domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each of which is scored from 1 (perfect health) to 5 (complete inability).
Time frame: 6 months
Number of phone calls to Rheumatology Outpatient Clinic
Time frame: 6 months
Number of additional, unscheduled rheumatology consultations
Time frame: 6 months
Number of consultations to GP due to prescribed treatment-related issues
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.