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Trial registered on ANZCTR


Registration number
ACTRN12624001125516
Ethics application status
Approved
Date submitted
3/09/2024
Date registered
18/09/2024
Date last updated
18/09/2024
Date data sharing statement initially provided
18/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
e-HANDI for prescribing Non-Drug Interventions in Primary Care: a pilot randomised controlled trial
Scientific title
Feasibility and Acceptability of the co-designed e-HANDI for Prescribing Non-Drug Interventions (NDIs) in General Practice: A pilot randomised controlled trial
Secondary ID [1] 312881 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiovascular 335034 0
chronic condition 335035 0
Condition category
Condition code
Cardiovascular 331539 331539 0 0
Hypertension
Diet and Nutrition 331540 331540 0 0
Other diet and nutrition disorders
Musculoskeletal 331541 331541 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
e-HANDI is a web-based tool designed to assist primary care physicians (GPs) in prescribing non-drug interventions (NDIs). It's developed in collaboration with GPs and patients to ensure practicality and ease of use. e-HANDI is a standalone web-based tool that GPs will use during the consultation should they want to search for and/or prescribe evidence-based, effective, non-drug interventions. Patients can receive their prescriptions either paper-based or electronic (message or email). The prescription and patient's use can be anonymously tracked and used to generate the feedback report.

Key functions include the e-prescription of effective NDIs such as the Mediterranean diet and cognitive behavioural therapy for insomnia and depression; feedback to GPs by generating reports for GPs comparing their NDI prescription patterns to peers and provide them with actionable plans to improve their prescription behaviours; and reminder systems to patients to encourage adherence to prescribed NDIs (i.e., fortnightly text messages for patients have not opened their prescription for 2 weeks).

The intervention will be provided for the whole duration of the study (24 weeks).
Intervention code [1] 329420 0
Treatment: Other
Intervention code [2] 329421 0
Lifestyle
Intervention code [3] 329422 0
Behaviour
Comparator / control treatment
standard practice. GPs will receive a monthly newsletter featuring newly added NDIs to RACGP HANDI. GPs can still advice and prescribe NDIs to their patients but will not have access to e-HANDI.
Control group
Active

Outcomes
Primary outcome [1] 339284 0
Prescription rates of non-drug interventions
Timepoint [1] 339284 0
at weeks 2, 6, 12, and 24 post-intervention commencement
Secondary outcome [1] 439366 0
The Acceptability of the Intervention
Timepoint [1] 439366 0
at week 24 post-intervention commencement.
Secondary outcome [2] 439571 0
Feasibility of Intervention Measure (FIM)
Timepoint [2] 439571 0
at week 24 post-intervention commencement.
Secondary outcome [3] 439572 0
Appropriateness of Intervention Measure (IAM)
Timepoint [3] 439572 0
at week 24 post-intervention commencement.
Secondary outcome [4] 439573 0
Dispensing rates of non-drug interventions
Timepoint [4] 439573 0
at week 24 post-intervention commencement.
Secondary outcome [5] 439574 0
Scalability of the intervention
Timepoint [5] 439574 0
at week 24 post-intervention commencement

Eligibility
Key inclusion criteria
We will recruit general practitioners (GPs) through our established networks of GPs including advertising by Australian Practice-Based Research Networks (e.g., GoldNet practice-based primary care research network in Southeast Queensland), and direct approach to GPs that are currently involved in various research programs within the Institute for Evidence Based Healthcare (IEBH). To be eligible, GPs should have been actively engaged in clinical practice within the past 12 months. Eligible participants may come from a range of experience levels and diverse geographical locations across Australia.

Patients will be recruited through GPs and e-HANDI. To be eligible, they should be adult (>18 years old) with a chronic condition and prescribed one of the effective NDIs in RACGP HANDI.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
International GPs

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation of GPs (1:1 for intervention:control) will be conducted by an independent researcher (not involved with intervention delivery or outcome measurement) using a computer-generated randomisation program and will be stratified according to remoteness (urban/regional areas) and workload. Study personnel involved in analysing study data will be blinded to the group allocation. Following randomisation and allocation, GPs, practice staff, and researchers involved in the intervention delivery will not be blinded to the group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of GPs (1:1 for intervention:control) will be conducted by an independent researcher (not involved with intervention delivery or outcome measurement) using a computer-generated randomisation program and will be stratified according to remoteness (urban/regional areas) and workload. Study personnel involved in analysing study data will be blinded to the group allocation. Following randomisation and allocation, GPs, practice staff, and researchers involved in the intervention delivery will not be blinded to the group allocation.
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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 317321 0
Government body
Name [1] 317321 0
NHMRC
Country [1] 317321 0
Australia
Funding source category [2] 317322 0
Charities/Societies/Foundations
Name [2] 317322 0
Heart Foundation
Country [2] 317322 0
Australia
Primary sponsor type
Government body
Name
NHMRC
Address
Country
Australia
Secondary sponsor category [1] 319604 0
Charities/Societies/Foundations
Name [1] 319604 0
Heart Foundation
Address [1] 319604 0
Country [1] 319604 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316052 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 316052 0
Ethics committee country [1] 316052 0
Australia
Date submitted for ethics approval [1] 316052 0
Approval date [1] 316052 0
28/03/2024
Ethics approval number [1] 316052 0
CD03291

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

Contacts
Principal investigator
Name 136622 0
A/Prof Loai Albarqouni
Address 136622 0
Institute for Evidence-Based Healthcare Faculty of Health Sciences and Medicine Bond University 14 University Dr, Robina, QLD, Australia 4229
Country 136622 0
Australia
Phone 136622 0
+61 7 5595 5201
Fax 136622 0
Email 136622 0
lalbarqo@bond.edu.au
Contact person for public queries
Name 136623 0
Loai Albarqouni
Address 136623 0
Institute for Evidence-Based Healthcare Faculty of Health Sciences and Medicine Bond University 14 University Dr, Robina, QLD, Australia 4229
Country 136623 0
Australia
Phone 136623 0
+61 7 5595 5201
Fax 136623 0
Email 136623 0
lalbarqo@bond.edu.au
Contact person for scientific queries
Name 136624 0
Loai Albarqouni
Address 136624 0
Institute for Evidence-Based Healthcare Faculty of Health Sciences and Medicine Bond University 14 University Dr, Robina, QLD, Australia 4229
Country 136624 0
Australia
Phone 136624 0
+61 7 5595 5201
Fax 136624 0
Email 136624 0
lalbarqo@bond.edu.au

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.