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Trial registered on ANZCTR


Registration number
ACTRN12624000817549
Ethics application status
Approved
Date submitted
27/04/2023
Date registered
3/07/2024
Date last updated
3/07/2024
Date data sharing statement initially provided
3/07/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can a pharmacist-led education and support intervention assist patients to reduce their glucocorticoid (steroid) dose and improve outcomes for patients with rheumatic diseases?
Scientific title
A randomised clinical trial of a novel pharmacist-led glucocorticoid tapering intervention for patients with rheumatic diseases
Secondary ID [1] 309481 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid arthritis 329746 0
Polymalgia Rheumatica 329748 0
Giant Cell Arteritis 329749 0
Systemic Lupus Erythematosus 329750 0
Inflammatory Myositis 329751 0
Condition category
Condition code
Inflammatory and Immune System 326645 326645 0 0
Rheumatoid arthritis
Inflammatory and Immune System 326646 326646 0 0
Autoimmune diseases
Inflammatory and Immune System 326647 326647 0 0
Connective tissue diseases
Public Health 327242 327242 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 325910 0
Treatment: Other
Comparator / control treatment
All control participants will all receive a written GC tapering plan form the pharmacist at baseline. As for the intervention group, 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 control group will then receive usual care with their Rheumatologist without pharmacist support reviews. Usual clinical care includes outpatient rheumatology visits 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.
Control group
Active

Outcomes
Primary outcome [1] 334515 0
Achievement of target GC dose at 6 months*
*Target dose to be set by rheumatologist at time of referral to study.
This will be assessed by the pharmacist at the final visit, based on the patients tapering checklist and verbal confirmation of the final dose.
Timepoint [1] 334515 0
6 months post initial pharmacist review
Secondary outcome [1] 420966 0
Percentage change in GC dose, based on pharmacist recorded initial and final doses.
Timepoint [1] 420966 0
6 and 12 months post initial pharmacist review
Secondary outcome [2] 420967 0
Incidence rate of disease relapse or flare as recorded by the pharmacist at each review.
Timepoint [2] 420967 0
6 and 12 months post initial pharmacist review
Secondary outcome [3] 421354 0
Patient reported GC adverse effects will be measured via electronic questionnaire using Redcap. Physician measured GC adverse effects to be measured include BMI (height and weight measured routinely by nursing staff during clinic visits and recorded in the clinical notes), blood pressure (measured routinely using digital sphygmomanometer by nursing staff during clinic visits and recorded in the clinical notes), increased blood sugar and cholesterol levels (assessed using fasting glucose and cholesterol via SA pathology and noted in clinical notes).
Timepoint [3] 421354 0
6 months post initial pharmacist review
Secondary outcome [4] 421355 0
Barriers to GC tapering as recorded by the pharmacist at each visit via phone/telehealth follow up interview. This will be guided by the patient reported barriers as reported in the Redcap follow up questionnaire.
Timepoint [4] 421355 0
6 months post initial pharmacist review (summary of all barriers collected at each intervention visit)

Eligibility
Key inclusion criteria
1. Age >=18 years
2. Clinical diagnosis of RA, SLE, Myositis, PMR or GCA made by a rheumatologist
3. New or longstanding GC use requiring tapering to lower dose or cessation over the next 6 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unable to provide informed consent
2. Non-rheumatological indication for GC use

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/02/2024
Date of last participant enrolment
Anticipated
24/12/2024
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
100
Accrual to date
48
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 24618 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 24619 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 40229 0
5000 - Adelaide
Recruitment postcode(s) [2] 40230 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 313677 0
Charities/Societies/Foundations
Name [1] 313677 0
Arthritis Australia
Country [1] 313677 0
Australia
Primary sponsor type
Hospital
Name
Central Adelaide Local Health Network
Address
Port Road, Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 315553 0
University
Name [1] 315553 0
University of Adelaide
Address [1] 315553 0
North Terrace, Adelaide, SA, 5000
Country [1] 315553 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312842 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 312842 0
North Terrace, Adelaide, SA, 5000
Ethics committee country [1] 312842 0
Australia
Date submitted for ethics approval [1] 312842 0
31/05/2023
Approval date [1] 312842 0
18/01/2024
Ethics approval number [1] 312842 0

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126110 0
Dr Rachel Black
Address 126110 0
Rheumatology Unit, Royal Adelaide Hospital, Port Road, Adelaide, SA, 5000
Country 126110 0
Australia
Phone 126110 0
+61 8 7074 2779
Fax 126110 0
Email 126110 0
[email protected]
Contact person for public queries
Name 126111 0
Rachel Black
Address 126111 0
Rheumatology Unit, Royal Adelaide Hospital, Port Road, Adelaide, SA, 5000
Country 126111 0
Australia
Phone 126111 0
+61 8 7074 2779
Fax 126111 0
Email 126111 0
[email protected]
Contact person for scientific queries
Name 126112 0
Rachel Black
Address 126112 0
Rheumatology Unit, Royal Adelaide Hospital, Port Road, Adelaide, SA, 5000
Country 126112 0
Australia
Phone 126112 0
+61 8 7074 2779
Fax 126112 0
Email 126112 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.