Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000052336
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
18/12/2025
Date registered
Help: Date registered
14/01/2026
Date last updated
Help: Date last updated
14/01/2026
Date data sharing statement initially provided
Help: Data sharing statement date
14/01/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating Medigrowth Patient Outcomes for mental Wellbeing, Efficacy and safety in the Real world (EMPOWER) Project
Scientific title
Evaluating Medigrowth Patient Outcomes for mental Wellbeing, Efficacy and safety in the Real world (EMPOWER Project)
Additional trial identifiers [1] 316175 0
Nil known
Universal Trial Number (UTN)
Trial acronym
EMPOWER
Related trial records

Health condition
Health condition(s) studied:
Anxiety 340152 0
Depression 340153 0
Sleep 340173 0
Chronic pain 340174 0
Condition category
Condition code
Mental Health 336344 336344 0 0
Anxiety
Mental Health 336345 336345 0 0
Depression
Mental Health 336360 336360 0 0
Autistic spectrum disorders
Mental Health 336361 336361 0 0
Other mental health disorders
Cancer 336362 336362 0 0
Any cancer
Musculoskeletal 336363 336363 0 0
Other muscular and skeletal disorders
Neurological 336365 336365 0 0
Epilepsy
Neurological 336366 336366 0 0
Other neurological disorders
Reproductive Health and Childbirth 336367 336367 0 0
Other reproductive health and childbirth disorders
Anaesthesiology 336368 336368 0 0
Pain management

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of the intervention or exposure
This four-year prospective, longitudinal, observational study will examine the safety and clinical efficacy of Medigrowth medicinal cannabis products being used by participants for a range of chronic medical conditions over a 12-month period. Participants will be Australian children (aged 5-17 years) with their parent/guardian and self-reporting adults who have presented to the online telehealth platform Azure Heath for alternative therapies. Participants will have received a prescription for medicinal cannabis products supplied by Medigrowth Australia under the Special Access Scheme or Authorised Prescriber pathways.

This study will track patient-reported efficacy using a range of validated questionnaires with a focus on mental health. The study will also collect information from participants about their demographics, work performance, medical history, concomitant therapies, prescribed Medigrowth products (including dosage), medication adherence, and side effects.

Participants will be assessed at baseline before starting medicinal cannabis treatment, as well as at 1 month, 3 months, 6 months, 9 months, and 12 months post-baseline. Each questionnaire is expected to take approximately 15 minutes to complete. Validated questionnaires will be used to measure anxiety, depression and stress (DASS-21), sleep (PROMIS Sleep Disturbance 8a), pain (PROMIS Pain Interference 8a and PROMIS Pain Intensity 1a), quality of life (EQ-5D-5L), work performance (HPQ Absenteeism/Presenteeism), and patient global impression of change (PGIC). Participants will self-complete questionnaires at home using their own device with an internet connection.

Note: Participants may receive Medigrowth medicinal cannabis products regardless of their involvement in this study.
Intervention code [1] 332810 0
Not applicable
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 343886 0
Changes in anxiety scores in adult or child (5-17 years) participants
Timepoint [1] 343886 0
Baseline (before starting Medigrowth medicinal cannabis products), 1 month, 3 months, 6 months, 9 months, and 12 months post-baseline
Primary outcome [2] 343887 0
Changes in depression scores in adult or child (5-17 years) participants
Timepoint [2] 343887 0
Baseline (before starting Medigrowth medicinal cannabis products), 1 month, 3 months, 6 months, 9 months, and 12 months post-baseline
Primary outcome [3] 343888 0
Changes in stress scores in adult or child (5-17 years) participants
Timepoint [3] 343888 0
Baseline (before starting Medigrowth medicinal cannabis products), 1 month, 3 months, 6 months, 9 months, and 12 months post-baseline
Secondary outcome [1] 456016 0
Changes in sleep scores in adult or child (5-17 years) participants
Timepoint [1] 456016 0
Baseline (before starting Medigrowth medicinal cannabis products), 1 month, 3 months, 6 months, 9 months, and 12 months post-baseline
Secondary outcome [2] 456017 0
Changes in pain interference scores in adult or child (5-17 years) participants
Timepoint [2] 456017 0
Baseline (before starting Medigrowth medicinal cannabis products), 1 month, 3 months, 6 months, 9 months, and 12 months post-baseline
Secondary outcome [3] 456018 0
Changes in pain intensity scores in adult or child (5-17 years) participants
Timepoint [3] 456018 0
Baseline (before starting Medigrowth medicinal cannabis products), 1 month, 3 months, 6 months, 9 months, and 12 months post-baseline
Secondary outcome [4] 456019 0
Changes in quality of life scores in adult or child (5-17 years) participants
Timepoint [4] 456019 0
Baseline (before starting Medigrowth medicinal cannabis products), 1 month, 3 months, 6 months, 9 months, and 12 months post-baseline
Secondary outcome [5] 456020 0
Changes in health impact on work performance in adult or parent/guardian participants who indicate they are working
Timepoint [5] 456020 0
Baseline (before starting Medigrowth medicinal cannabis products), 1 month, 3 months, 6 months, 9 months, and 12 months post-baseline
Secondary outcome [6] 456022 0
Changes in global impression of change scores in adult, parents/guardians of child participants, and child (5-17 years) participants.
Timepoint [6] 456022 0
1 month, 3 months, 6 months, 9 months, and 12 months post-baseline

Eligibility
Key inclusion criteria
Self-reporting adult participants:
1. All genders aged 18 years or older,
2. Seeking treatment for a refractory chronic medical condition at Azure Health,
3. Suitable for medicinal cannabis in the professional opinion of the treating Azure Health clinician and has consented to being prescribed products supplied by Medigrowth Australia as per standard clinical practice (via the SAS or AP pathways),
4. Can read and understand English and complete study questionnaires,
5. Can provide informed consent

Parent/guardian participants (children aged 5-17 years):
1. All genders with children aged 5-17 years,
2. Child is seeking treatment for a refractory chronic medical condition at Azure Health,
3. Child is suitable for medicinal cannabis in the professional opinion of the treating Azure Health clinician and has consented to being prescribed products supplied by Medigrowth Australia as per standard clinical practice (via the SAS or AP pathways),
4. Parent/guardian can read and understand English and engage with their child to complete study questionnaires,
5. Parent/guardian can provide informed consent on behalf of their child aged 5-17 years.
Minimum age
5 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1. Aged less than 5 years,
2. Unable to read and understand English and complete study questionnaires,
3. Unable to provide informed consent.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data will be analysed using Jamovi and/or R, which are open source and freely available. Baseline demographic and clinical data for participants will be summarised descriptively and by subgroups, where possible. Categorical variables will be presented as frequencies and percentages. Continuous variables will be presented with summary statistics (number of participants, mean, standard deviation, median, and range for variables). Baseline and follow-up patient-reported outcome scores will be summarised descriptively and by subgroups of interest where possible. Paired t-tests or non-parametric tests may be used to examine change in patient reported outcomes from baseline to each follow-up time point. Associations between demographic, clinical, and longitudinal patient-reported outcome scores will be examined using regression methods adjusted for covariates. Statistical analyses will be conducted on a prespecified yearly basis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/01/2026
Actual
Date of last participant enrolment
Anticipated
31/12/2028
Actual
Date of last data collection
Anticipated
31/12/2029
Actual
Sample size
Target
5000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 320774 0
Commercial sector/Industry
Name [1] 320774 0
Medigrowth Australia Pty Ltd
Country [1] 320774 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 323449 0
None
Name [1] 323449 0
Address [1] 323449 0
Country [1] 323449 0
Other collaborator category [1] 283792 0
Other
Name [1] 283792 0
Azure Health
Address [1] 283792 0
Country [1] 283792 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319307 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 319307 0
Ethics committee country [1] 319307 0
Australia
Date submitted for ethics approval [1] 319307 0
18/07/2025
Approval date [1] 319307 0
15/12/2025
Ethics approval number [1] 319307 0

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

Contacts
Principal investigator
Name 146926 0
Dr Talitha Ford
Address 146926 0
Cognitive Neuroscience Unit (CNU), School of Psychology, Deakin University 221 Burwood Hwy, Burwood VIC 3125
Country 146926 0
Australia
Phone 146926 0
+61 03 92468730
Fax 146926 0
Email 146926 0
[email protected]
Contact person for public queries
Name 146927 0
Talitha Ford
Address 146927 0
Cognitive Neuroscience Unit (CNU), School of Psychology, Deakin University 221 Burwood Hwy, Burwood VIC 3125
Country 146927 0
Australia
Phone 146927 0
+61 03 92468730
Fax 146927 0
Email 146927 0
[email protected]
Contact person for scientific queries
Name 146928 0
Talitha Ford
Address 146928 0
Cognitive Neuroscience Unit (CNU), School of Psychology, Deakin University 221 Burwood Hwy, Burwood VIC 3125
Country 146928 0
Australia
Phone 146928 0
+61 03 92468730
Fax 146928 0
Email 146928 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
A finite period of: 5 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Access to the data via Open Science Framework may be requested by emailing the principal investigator, Talitha Ford, [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.