Integration of Remote Monitoring in the Management of Chronic Immunosuppressive Therapy
NCT Number: NCT06544343
Acronym: TEMPLATE
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Rheumatoid Arthritis|Psoriatic Arthritis|Systemic Lupus Erythematosus|Systemic Sclerosis|Spondyloarthritis, Axial|Ankylosing Spondylitis
Interventions: OTHER: Remote Monitoring|OTHER: On site monitoring
Sponsor: University Of Perugia
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 190
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2026-03-18
Locations: Rheumatology Unit - Perugia Univeristy Hospital, Perugia, PG, 06129, Italy

Summary:
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.

Primary Outcome Measures: Treatment persistence, Percentage of patients taking the same medication prescribed at baseline, 6 months
Secondary Outcome Measures: Treatment Persistence, Percentage of patients taking the same medication prescribed at baseline, 3 months|Disease activity score on 28 joints with C-Reactive Protein (DAS28-CRP), Only applies to rheumatoid arthritis patients, 3 months|Disease activity score on 28 joints with C-Reactive Protein (DAS28-CRP), Only applies to rheumatoid arthritis patients, 6 months|Psoriatic Arthritis Disease Activity Score (PASDAS), Only applies to psoriatic arthritis patients, 3 months|Psoriatic Arthritis Disease Activity Score (PASDAS), Only applies to psoriatic arthritis patients, 6 months|Body Surface Area (BSA), Percentage of skin surface with psoriatic lesions. Only applies to psoriatic arthritis patients, 3 months|Body Surface Area (BSA), Percentage of skin surface with psoriatic lesions. Only applies to psoriatic arthritis patients, 6 months|Minimal Disease Activity (MDA), Binary outcome. Only applies to psoriatic arthritis patients, 3 months|Minimal Disease Activity (MDA), Binary outcome. Only applies to psoriatic arthritis patients, 6 months|Modified Rodnan's skin score, Only applies to systemic sclerosis patients, 3 months|Modified Rodnan's skin score, Only applies to systemic sclerosis patients, 6 months|Medical Research Council (MRC) dyspnoea scale, Only applies to systemic sclerosis patients with interstitial lung disease, 3 months|Medical Research Council (MRC) dyspnoea scale, Only applies to systemic sclerosis patients with interstitial lung disease, 6 months|EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI), Only applies to Sjogren's disease patients, 3 months|EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI), Only applies to Sjogren's disease patients, 6 months|EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI), Only applies to Sjogren's disease patients, 3 months|EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI), Only applies to Sjogren's disease patients, 6 months|Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K, Only applies to systemic lupus erythematosus patients, 3 months|Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K, Only applies to systemic lupus erythematosus patients, 6 months|Ankylosing Spondylitis Disease Activity Score (ASDAS), Only applies to ankylosing spondylitis and axial spondyloarthritis patients, 3 months|Ankylosing Spondylitis Disease Activity Score (ASDAS), Only applies to ankylosing spondylitis and axial spondyloarthritis patients, 6 months|Health Assessment Questionnaire Disability Index (HAQ-DI), Range 0 (best condition) - 3 (worst condition), 3 months|Health Assessment Questionnaire Disability Index (HAQ-DI), Range 0 (best condition) - 3 (worst condition), 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), 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), 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)., 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)., 6 months|Number of phone calls to Rheumatology Outpatient Clinic, 6 months|Number of additional, unscheduled rheumatology consultations, 6 months|Number of consultations to GP due to prescribed treatment-related issues, 6 months