ANZCTR search results

This pilot randomised controlled clinical trial will explore the feasibility of delivering a new, in-home intervention to individuals with an alcohol use disorder and acquired brain injury. It aims to generate exploratory data on treatment engagement, change in alcohol use, community participation, and healthcare utilisation/costs that could inform hypotheses for a larger clinical trial.

This is a Phase 2b, randomized, double-blind, placebo-controlled, multicentre trial evaluating two dose levels of BRP-185 against placebo in adult patients diagnosed with idiopathic hypersomnia. Participants will be randomly assigned in a 1:1:1 ratio to one of the following arms: 1. High-dose BRP-185 group (225 mg) – orally once daily in the morning 2. Low-dose BRP-185 group (150 mg) – orally once daily in the morning 3. Placebo group – orally once daily in the morning This trial aims to provide critical data on BRP-185's ability to improve wakefulness and reduce hypersomnolence symptoms, addressing an unmet need in the treatment of idiopathic hypersomnia.

This is a multicentre trial that will evaluate the diagnostic and clinical accuracy (utility) of home-based L3 sleep studies compared to the current standard of laboratory-based polysomnography (L1 PSG). The clinical utility will be determined by including participants who reflect all of the clinical subgroups that comprise a typical clinical load in Australian paediatric sleep laboratories.

This single group pilot trial will evaluate the outcomes, feasibility and acceptability of a brief, 4-module online, CBT treatment targeting rumination and worry in adults tailored to individuals with Premenstrual Dysphoric Disorder (PMDD) or heightened premenstrual distress. Outcomes will be measured from pre-to post-treatment and up to 5 weeks follow-up.

The primary aim of this study is to test the feasibility of a clinical trial comparing TENS alone to TENS combined with self-selected music, in patients with persistent spinal pain. The results of this feasibility study will be used to inform a larger trial of these interventions in patients with persistent spinal pain. A secondary aim is to study the analgesic effects of each intervention over the course of the TENS treatment, impact of participant's function and mood and adverse outcomes.We hypothesise that administration of TENS combined with music will be equally feasible compared to TENS alone, and will be well tolerated by participants. Secondly, we hypothesise that participants will have superior analgesia when TENS is combined with music treatment will have improved analgesia compared to TENS alone.

Unfortunately, many people will experience knee osteoarthritis at some point in their life. This can be diagnosed by a health professional. People often have beliefs about treatments for, and the prognosis of, their knee osteoarthritis. Currently, we do not know whether the advice someone receives makes any difference to their beliefs about osteoarthritis treatment or prognosis. This study is interested in learning more about this, and whether different ways of providing advice about knee osteoarthritis impacts people’s beliefs about the condition.

This study aims to assess whether a remotely supervised home-based minimal equipment exercise training program is a feasible and acceptable model of pulmonary rehabilitation for people with chronic respiratory disease. Participants assigned to the intervention group will complete home-based minimal equipment exercise training delivered using remote supervision (video-conferencing, Zoom). This involves 8 weeks of twice-weekly remotely supervised (via video-conferencing) exercise training sessions in groups of 2-4 participants. Participants will be able to interact via video-conferencing technology with other group participants and the supervising clinician. Each session, participants will undertake circuit-based training incorporating 7 exercises. The total training session duration will be 45minutes; each exercise circuit will be between 15-16minutes in duration (including interval rests) and repeated 3 times, accounting for a total exercise time of 31.5minutes. A 5minute rest period will be undertaken between each circuit. Additional to this, the intervention group will complete a short questionnaire and a qualitative interview with a clinician following their engagement in the program to understand participant experiences.

Gestational diabetes (GDM) is one of the most common medical complications of pregnancy and its incidence is rising. Due to the large population that continually requires this service, the current model of care is inconvenient, inefficient, unsustainable, and expensive for both patients and health care providers. This trial is an unblinded single centre randomized control trial comparing remote blood sugar monitoring solution via a web-based dashboard to conventional clinic based consultations in gestational diabetes. It will compare pregnancy, foetal, neonatal, patient satisfaction and cost outcomes.

We propose a randomised control trial to explore whether pacemaker programming, specifically an increased atrial pacing rate, can improve atrial fibrillation (AF) outcomes for older patients with concurrent sinus node disease. Participants will be randomised to either an increased atrial pacing rate, or atrial back-up pacing. The primary outcome will be AF burden.

Our research team developed a prevention and treatment program (RESP-ACT) based on internationally agreed recommendations for preventing and managing respiratory disease in children with cerebral palsy (CP) and then tested its feasibility (ACTRN12620000114943). The aims of this study are to reduce respiratory health service usage (hospital days and presentations to emergency department) and to increase the reach, adoption, implementation, and maintenance of RESP-ACT. The objectives are to implement RESP-ACT at Perth Children’s Hospital for all children with CP who are at risk of respiratory disease. Implementation will involve clinician training, a collaborative environment, strategies tailored to address referral barriers, team facilitation, audit, and feedback, and to assess its feasibility, utility, and effectiveness.