Integration of Remote Monitoring in the Management of Chronic Immunosuppressive Therapy

Sponsor
University Of Perugia
Study ID
NCT06544343
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Remote Monitoring — OTHER
    Follow-up at outpatient clinic at 3 and 6 months from drug prescription Two remote consultations at 15 and 45 days from drug prescription
  • On site monitoring — OTHER
    Follow-up at outpatient clinic at 3 and 6 months from drug prescription.

Study Details

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.

Key Dates

First listed
Aug 9, 2024
Start date
Jul 1, 2024
Status verified
Aug 2024
Primary completion
Mar 18, 2026
Completion
Mar 18, 2026

Study Design

Enrollment
190 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Remote Monitoring
  • Placebo Comparator: On site only

Primary Outcome Measure

Treatment persistence [ Time Frame: 6 months ]

Find similar trials

Nationwide
Psoriatic arthritis trialsRheumatoid arthritis trialsLupus (SLE) trialsRheumatology trialsAutoimmune disease trialsMusculoskeletal disorders trials

Related Studies