ANZCTR search results

This randomised, open-label, intervention study aims to implement culturally appropriate coordination for personalised rehabilitation programs over and above the usual pathways of care for Aboriginal and Torres Strait Islander people returning to the community following a heart, stroke or diabetes-related hospitalisation at the Royal Adelaide Hospital. Aboriginal Australians face an epidemic of chronic disease and a significant gap in total disease burden compared to non-Aboriginal Australians. Rehabilitation is key to managing chronic diseases, reducing mortality, unnecessary re-hospitalisations and healthcare costs. The study aims to recruit 300 Aboriginal or Torres Strait Islander adults who are hospitalised with chronic disease and referred to specialised rehabilitation. Eligible participants will be randomised to receive 12-months of coordinated care for their individualised rehabilitation plan (intervention) or usual care (control). The study will determine whether coordinated care for rehabilitation plans improve the receipt of evidence-based healthcare and quality of life for Aboriginal people with chronic disease.

A double-blind randomised controlled trial in persistent post-concussion symptoms (PPCS). The treatment involves psychotherapy sessions before and after one dose of a psychedelic drug called psilocybin, and a daily self-directed integration program for the 2-week period after the psychedelic session. In addition, the research study also involves several screening procedures, blood collection, neuroimaging and completion of questionnaires and interviews.

Trial of Electronic Patient Reported Outcome Measures (ePROMs) for the collection of primary endpoints in a trial of lignocaine for the prevention of post-operative pain in breast cancer surgery. Brief description of the study purpose The LOLIPOP Trial ePROMs substudy aims to test how reliable and acceptable electronic patient reported outcome measures (ePROMs) are for collecting pain information from participants in the LOLIPOP trial. The study compares pain data collected electronically with pain data collected by telephone follow up and explores which follow up method participants prefer for future research. Who is it for? You may be eligible for this study if you are in Australia who have already consented to take part in the LOLIPOP trial and agree to opt in to this substudy. Study details Participants will be invited to complete pain questionnaires electronically using a secure system called ePROMs that sends reminders by email and/or SMS around 12 months after their surgery. All participants will also receive a standard follow up phone call from a research coordinator to collect the same pain information, allowing comparison between electronic and phone based data collection. It is hoped that the findings will help provide further information on which form of follow up participants would most prefer for future research.

This study aims to compare usual care with a remotely delivered, dietitian led very low calorie diet (VLCD) program to assess whether pre surgery weight loss is safe and acceptable for patients with excess weight awaiting colorectal cancer surgery. Who is it for? You may be eligible for this study if you are aged 18 or over, with a body mass index (BMI) of 28kg/m² or above, and scheduled for elective colorectal cancer surgery. Study details All eligible participants will take part in a multicentre, two arm randomised controlled trial conducted across Metro South Health facilities. Participants will be randomly assigned to one of two groups: usual care (no weight loss intervention before surgery) or participation in a remotely delivered, dietitian led very low calorie diet clinic prior to surgery. Participants allocated to the intervention group will follow an individualised VLCD at home, supported by weekly dietitian appointments delivered via telehealth (video or phone). The diet uses meal replacement products alongside selected vegetables and fluids and is tailored to individual needs. Dietitians will provide education, monitor adherence, and offer ongoing support until surgery, with additional contact by SMS or email if required. Participants in the usual care group will proceed to surgery without a pre operative weight loss program. After completion of the intervention, participants will be assessed for adverse events, physical function and surgical outcomes. It is hoped this research will inform clinical practice by clarifying whether a remotely delivered VLCD program is a safe and acceptable pre operative approach for people with excess weight undergoing colorectal cancer surgery, helping guide future care decisions and improve surgical outcomes.

This study aims to evaluate whether a nurse-led clinic using electronic symptom monitoring can improve support for women starting adjuvant endocrine therapy after early breast cancer treatment. Who is it for? This study is for women aged 18 years or older diagnosed with primary early-stage hormone receptor–positive breast cancer, prescribed and consenting to commence adjuvant endocrine therapy (AET) and able to read and understand English. Study details Participants will complete regular online symptom assessments during the first 12 weeks of treatment which will be reviewed by cancer care nurse specialists. All participants will be included in the study if they meet the eligibility criteria and consent. There are no tests required for the study however depending on specialist nurse review of reported symptoms and side effects participants may be referred for tests as part of their disease management. It is hoped this nurse-led clinic using electronic symptom monitoring can improve symptom management and treatment adherence while reducing the need for routine oncology follow-up visits.

A stroke occurs when a clot blocks one of the blood vessels to the brain. This causes poor blood supply and lack of oxygen to the brain tissue. If blood supply is not restored to the brain there is permanent brain damage. Endovascular thrombectomy is an effective treatment to restore blood supply to the brain and reduce disability. However, patients with extensive brain injury due to the stroke can develop brain swelling after restoration of blood flow that increases pressure inside the skull and can cause drowsiness, increased disability and potentially death. This swelling tends to occur over the first 3 days. The aim of this study is to test whether a medication called glibenclamide can reduce this brain swelling and improve outcome after stroke.

This is a multicentre Phase II clinical trial to establish if Deflexifol is safe and effective in children, adolescents and young adults with recurrent or refractory brain tumours. Who is it for? Participants may be eligible for this study if they are older than 12 months and up to 21 years old and have a recurrent or refractory ependymoma. Study details Participants will receive Deflexifol every 2 weeks for up to approximately one year, if there is ongoing clinical benefit. Deflexifol will be administered via an injection over 3-5 minutes (bolus), followed by a continuous intravenous infusion over 46 hours. Safety will be assessed throughout the course of treatment and during follow up visits. Participants will have physical examinations, blood tests, urine tests, echocardiogram, electrocardiogram (ECG) and MRI scans. This study will test the safety and effectiveness of this drug in children and adolescents in cases where treatment options are limited.

This study aims to implement and evaluate a culturally adapted, web-based dementia prevention intervention that targets Culturally and Linguistically Diverse (CALD) individuals from South Asian, Middle Eastern, Sub-Saharan African, and Pacific Islander communities to take early action to reduce their risk of dementia. The intervention was co-designed with target CALD communities, with the content closely aligning with current dementia prevention evidence. MindCare-D comprises of 16 modules that address modifiable dementia risk factors (e.g. physical inactivity, social connection). While MindCare-D Plus includes additional personalised behavioural support through SMS messages and monthly health coach sessions. We hypothesise that: a) participants receiving MindCare-D and MindCare-D Plus will demonstrate greater reductions in dementia risk scores (CogDrisk), and greater improvements in health activation (PAM-13) and dementia risk knowledge (KoDeRR), compared to those receiving usual care, at 6, 12, and 24 months. b) MindCare-D and MindCare-D Plus will meet implementation benchmarks for acceptability (greater than or equal to 70% of participants rating it acceptable or completely acceptable), feasibility, and high fidelity (greater than or equal to 80% adherence)

In this research project we will expand the scope of intracranial evaluations to include placement of electrodes in deep structures of the brain, and to perform temporary 'trials' of stimulation to mimic various treatment strategies. This will help us to choose the best intervention for these people and to design DBS systems personalised to their epilepsy. We will then evaluate whether these personalised DBS systems show seizure reduction exceeding that reported in existing DBS studies.

Persistent upper airway symptoms such as postnasal drip (PND), throat clearing, mucus sensation, and chronic cough are common patient complaints, that can significantly impair quality of life. These symptoms are often secondary to active allergy and reflux, and as a result, commonly improve but not always fully resolve, following management of these types of primary conditions. Given the lack of a direct treatment standard targeting residual symptoms, and their association with a sensory irritation origin, this study will investigate the effectiveness of persistent blockade of the "cold sensor", TRPM8, receptor using oral lozenges for the management of postnasal drip and mucus symptoms.