Trial Details

Recruiting
Basic Information
Clinical ID c1993
Identifier ACTRN12625000186459
Trial Title Prospective parallel cohort study of virtual clinic model of care versus__traditional standard of care in management of patients undertaking dosage intensification of biologic therapies due to secondary loss of response or pharmacokinetic failure.
Trial URL Visit Original Page
Study Information
Study Results

No results available

Conditions inflammatory bowel disease__; inflammatory bowel disease ;Inflammatory and Immune System - Autoimmune diseases;Public Health - Health service research
Interventions A single tertiary centre that has an established virtual biologics clinic, where enrolled patients are reviewed in their absence with up to date clinical and objective disease assessment, captured through a patient reported outcome monitoring portal, IBD nurse/pharmacist pphone review and standardised objective disease assessment. All patients at the intervention site (Austin Health) that meet inclusion criteria who are deemed appropriate for dosage intensification of their biologic regimen from their baseline dosage and who agree to participate in the study will have their ongoing treatment and assessments outlined via the virtual clinic model. Patients in the standard care cohort will have treatment, monitoring and follow up scheduled by their individual clinician. Patients in intervention cohort will be managed through protocolised multidisciplinary care, with follow up assessment and virtual clinic review, in addition to TWO in person clinic reviews, scheduled as per the individual needs of the patient and as agreed by the multidisciplinary team including clinician, IBD pharmacist and IBD nurse over the 48 week study timeframe. There will be no limit on the number of virtual clinic reviews conducted for each patient with rveiews scheduled as per the individual needs of that patient. Patients in both study cohorts will undergo objective and clinical disease assessment at baseline, week 12, week 24 and week 48.
Participant Information
Sponsor Austin Health Hospital
City -
Country/Region Australia
Enrollment Criteria
Sex Requirement ALL
Age Requirement ADULT, ELDER, OLDER_ADULT
Study Design
Study Type Interventional
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -