None listed
Conditions
Brief summary
This study aims to track adult and child (aged 5-17 years) participants who are using Medigrowth medicinal cannabis products for any chronic medical condition over a 12-month period. Who is it for? You may be eligible if you are an adult who is 18 years or older, seeking treatment for a refractory chronic medical condition at Azure Health, and considered suitable for medicinal cannabis by an Azure Health clinician. You must consent to being prescribed products supplied by Medigrowth Australia as per standard clinical practice (via the SAS or AP pathways), be able to read and understand English to complete study questionnaires, and provide informed consent. Alternatively, you may be eligible if you are a parent or guardian of a child aged 5–17 years who is seeking treatment for a refractory chronic medical condition at Azure Health and is considered suitable for medicinal cannabis by an Azure Health clinician. You must consent to your child being prescribed products supplied by Medigrowth Australia as per standard clinical practice (via the SAS or AP pathways), be able to read and understand English and assist your child to complete study questionnaires, and provide informed consent on behalf of your child. Study details Study participants will complete online questionnaires prior to starting their Medigrowth medicinal cannabis products (baseline), and then at 1 month, 3 months, 6 months, 9 months, and 12 months after entering the study. Questionnaires will assess patient-reported changes in mental health, pain, sleep, quality of life, global impression of change, and work performance using validated questionnaires. The study will also collect information on demographics, medical history, other therapies, and track how Medigrowth products are being used over time, including an estimate of CBD/THC dosages. The findings of this study are expected to inform clinicians about the safety and efficacy of Medigrowth medicinal cannabis products, and the outcomes may be used to inform future randomised controlled trials for specific indications.
Interventions
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 me
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.
Sponsors
Deakin University
Eligibility
Sex/Gender
All
Age
5 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed