ANZCTR search results

Reducing tobacco use is an urgent national health priority in Australia, as it is the leading cause of preventable death and disability. The Incentive to Quit (I2Q) pilot aims to reduce harms associated with smoking and vaping by; i) training health professionals on delivering brief smoking cessation advice, ii) providing eligible smokers and vapers with financial incentives, iii) referring participants to the Quitline counselling service, and iv) providing pocket-sized resources with content to facilitate and support quit attempts. For health professionals, four levels of education + training will be available to develop skills, knowledge, and confidence in providing brief advice, and understanding issues specific to priority group support. Participants will be offered several sources of support to increase chances of success in their quit smoking journey at three time-points: baseline, 3-months, and 6-months. Milestone achievements include attempts to quit smoking, participation in Quitline counselling, and successful quitting confirmed through biochemical validation. Feasibility and acceptability of the program will be evaluated through the systematic, rigorous RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) framework. The primary outcome is to determine potential efficacy of the I2Q program to encourage smoker/vaper abstinence as an adjunct to standard health service delivery, evaluated by the number of smokers with biochemically validated abstinence at 3-month and 6-month follow-up, and the number of smokers that enrolled into the I2Q program. Secondary outcomes are to determine the feasibility and acceptability of the I2Q program to support smoker quit attempts, and potential for up-scale and expansion.

This study aims to evaluate the acceptability, feasibility, and short-term effects of a coach-supported online parenting program for parents of autistic children, to reduce children's symptoms of depression and anxiety. The online intervention is comprised of 2 components; up to 15 online self guided educational modules empowering parents to support their child in the context of reducing anxiety and depression, and up to 8 one-on-one telehealth coaching sessions with a provisional psychologist to support parents in learning, understanding and modifying their parenting practices. It is hypothesised that from pre to post intervention (120 days later): (1) From pre- to post-intervention (120 days later), there will be a parent reported increase in preventive parenting practices and parental self-efficacy, as well as a reduction in parent psychological distress (2) From pre- to post-intervention (120 days later), there will be a reduction in parent reported child anxiety, depressive symptoms, sleep problems, and emotion dysregulation. Additionally there will be an increase in child participation; At post intervention (120 days later): (3) Parents and coaches will find the PiP Kids-Autism program satisfactory, acceptable and feasible to implement.

This study will recruit participants who attend Armadale Hospital (public) Emergency Department (ED) with acute low back pain. They will be randomized into groups, and the intervention group fitted with an abdominal brace. The hypothesis is that in people with mechanical low back pain, wearing a brace will reduce their pain (and increase activity and quality of life [QoL]). The participants will be asked to wear the brace for up to 30 days when in pain during the day and if they feel that the brace is helpful. Low back pain, function, QoL and health care usage will be tracked for 3 months from the date of attendance at ED.

This is a randomised, blinded and controlled Phase I/IIa trial to measure the safety, feasibility and efficacy of a combined cell transplantation and intensive rehabilitation intervention to treat spinal cord injury. The trial aims to examine whether transplantation of olfactory cell nerve bridges combined with intensive rehabilitation is safe and feasible for people living with chronic spinal cord injury in Australia, and whether the intervention improves structural integrity of the spinal cord, functional recovery, overall health, and social wellbeing.

Study approved by bellberry ethics committee K on 19th February 2024. This is a single-centre, single ascending dose study to assess the safety of lanreotide Extended-Release Formulation, and how this drug acts in the body in healthy volunteers. Lanreotide may be indicated for use in patients with neuroendocrine cancer, but a trial of the drug in healthy volunteers is needed before trials in cancer patients can proceed. Who is it for? You may be eligible for this study if you are aged 18 to 55 years and are in good general health without a clinically significant medical history. People who have been diagnosed with cancer will not be eligible for this study. Participants who choose to enrol in this study may be enrolled into one of three dose cohorts. Healthy volunteer participants may receive either a single dose of lanreotide ERF administered as a subcutaneous (under the skin) injection or a single dose of lanreotide ERF administered as an intramuscular (into a muscle) injection. All participants will have their vital signs checked and will provide blood samples for testing. It is hoped this research will determine the maximum dose and best injection method for lanreotide ERF that can be administered safely without causing severe reactions. Once the dose of lanreotide ERF has been determined in healthy volunteers, a trial investigating the efficacy of lanreotide ERF as a treatment for neuroendocrine cancer patients may proceed.

Cardiovascular disease is the leading cause of death and disability among adults globally. In Australia it is the lead contributor to health care expenditure and with an ageing population the burden of disease is expected to increase. Cardiac rehab is an effective secondary prevention tool post acute coronary syndrome acute coronary syndrome but is underutilised and inconsistently delivered. The trial will whether early cardiac rehabilitation in high-risk acute coronary syndrome results in greater functional improvement at 6 months when compared to later and standard of care, examine the safety of cardiopulmonary testing to support exercise prescription, and define the metabolic profiles of post acute coronary syndrome.

This study is looking at follicular unit extraction to treat hidradenitis suppurativa, a condition that causes inflammation of hair follicles resulting in severe pain and scarring. Follicular unit extraction is a technique used in hair transplants to entirely remove hair follicles. We want to test whether or not by removing hair follicles using hair follicle extraction technique reduces inflammation and improve the quality of patients’ life. We will do hair follicle extraction on both sides of either the armpit or groin and compare it with topical routine treatments to assess whether or not there is improvement. We will follow the participants until week 24 of the study.

Post-stroke fatigue is a common and debilitating consequence of stroke, affecting over half of all stroke survivors, which can persist for years and interferes with recovery. Education is recommended but stroke survivors report that health professionals provide minimal information about fatigue that is difficult to apply to their daily life. This project will evaluate a co-designed education tool called the Fatigue-o-meter via a proof-of-concept study design.

Heart2Heart is a community-based randomised controlled trial with 12 months follow-up. The aim of the study is to determine whether implementation of a digital peer support program for people living with CHD is effective in improving social connectedness, clinical and patient-reported outcomes and experience measures. The intervention group will have access to a 6-month intervention that enables peer support via an interactive mobile application, which includes online discussion groups, access to resources and facilitated conversations with health professionals. If effective, the digital peer support intervention has the potential to increase social connectedness and empower people to self-manage and support others through sharing lived experience and learning.

Current pharmacotherapy options of haemodynamic support in critically ill patients with vasodilatory hypotension are limited. Centhaquine is a novel agent that has a dual action on the sympathetic system and may helped in the management of hypotensive states. We hypothesise that, compared to placebo, centhaquine will be associated with higher stroke volume, higher central venous pressure, higher mean arterial pressure, and lower vasopressor agent use over six hours after initiation of the study infusion. We plan to enrol 18 adult patients.