RecruitingACTRN12624000817549

Can a pharmacist-led education and support intervention assist patients to reduce their glucocorticoid (steroid) dose and improve outcomes for patients with rheumatic diseases?

A randomised clinical trial of a novel pharmacist-led glucocorticoid tapering intervention for patients with rheumatic diseases


Sponsor

Central Adelaide Local Health Network

Enrollment

100 participants

Start Date

Feb 13, 2024

Study Type

Interventional

Conditions

Summary

Glucocorticoids (GCs, also known as steroids or prednisolone) are often used to treat rheumatic diseases such as Rheumatoid Arthritis (RA), Polymyalgia Rheumatica (PMR) and Giant Cell Arteritis (GCA), While they can relieve symptoms, they are also associated with many side effects including reduced life expectancy, infection, weight gain, hypertension, diabetes, osteoporosis, cataracts, mood disturbance, thin skin, and easy bruising. In recognition of this, Australian Living Guidelines for RA recommend against the long-term use of GCs. However, studies have shown that once GCs are started, they are often difficult to stop even when the joint disease of RA appears to be well-controlled. Reducing and stopping GCs is often difficult to achieve in the clinic setting, where there are insufficient resources to provide comprehensive education and support. There are no proven methods to improve implementation of these recommendations. The aim of this study is to develop a pharmacist-led GC intervention to assist with GC reduction and cessation and minimise the side effects associated with GC use in patients with rheumatic diseases compared to “usual care”. Rheumatologists will refer people with RA, PMR and GCA who require gradual reduction of GC dose and/or cessation. Patients will either receive the new pharmacist-led intervention or receive “usual care” in an existing routine clinic plus a written schedule for reducing the GC dose from the pharmacist. Patients in the new intervention arm will receive 4-weekly telehealth appointments or phone calls when the pharmacist will collect patient reported data on dose, side effects, and barriers to dose reduction. All participants will have face-to-face visits at baseline, 6 months, and 12 months, when additional information including height, weight, BMI, blood pressure, disease activity and relapse will be collected. The aim will be to see if the pharmacist-led intervention increases the likelihood of achieving the target GC dose at 6 months and reduces the overall GC dose, relapses/flares, side effects, ED presentations and hospitalisations.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Glucocorticoids (steroids such as prednisolone) are widely used to reduce inflammation in conditions like rheumatoid arthritis, polymyalgia rheumatica, and giant cell arteritis. While they can be highly effective, long-term use carries significant risks — including increased susceptibility to infections, weight gain, high blood pressure, diabetes, and osteoporosis. Despite this, many people find it very difficult to reduce or stop steroids once they have started. This study is testing whether a pharmacist-led support program — offering telehealth appointments and personalised guidance on tapering down steroid doses — can help people with rheumatic diseases reduce their steroid use more effectively than the usual approach. Participants will either receive the pharmacist-led intervention or continue with standard clinic care, plus a written schedule for reducing their dose. You may be eligible if you are 18 or older, have been diagnosed with rheumatoid arthritis, lupus, myositis, polymyalgia rheumatica, or giant cell arteritis, and are currently taking glucocorticoids that need to be reduced or stopped over the next six months.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Patients randomised to the intervention group will receive Telehealth or phone reviews with the study pharmacist every 4 weeks for 16 weeks. At these appointments the pharmacist will provide support f

Patients randomised to the intervention group will receive Telehealth or phone reviews with the study pharmacist every 4 weeks for 16 weeks. At these appointments the pharmacist will provide support for patients as they taper their GCs as per a written schedule provided at the baseline visit. This tapering schedule will be individualised for each patient, according to their current and target dose. The schedule will be created by the pharmacist in conjunction with the treating rheumatologist, and will be based on usual clinical practice. Where available and clinically appropriate, tapering guidelines may be followed (for example, GiACTA for GCA and EUROLUPUS for SLE). The printed schedule will require patients to check off each dose reduction, with space provided for them to record alterations to dose (ie missed doses, increased doses, missed taper etc). The pharmacist will also record any patient reported adverse effects or barriers to tapering including relapse or flare. These visits will be in addition to usual care with their rheumatologist, which will involve outpatient clinic reviews scheduled as frequently as clinically required, which will vary depending on diagnosis, clinical response and individual patient needs. Patients may also contact the rheumatology department between visits for phone advice from rheumatology nurses or doctors regarding flares and medication queries.


Locations(2)

The Royal Adelaide Hospital - Adelaide

SA, Australia

The Queen Elizabeth Hospital - Woodville

SA, Australia

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ACTRN12624000817549


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