ANZCTR search results

Chronic pain is a common problem but often undiagnosed and untreated in people with dementia due to their cognitive impairment and limited communication ability, leading to reduced quality of life and increased healthcare costs. The efficacy and economic value of interventions to reduce pain in people with dementia remains unclear due to a lack of clinically useful pain assessment tools for this group. This study will (1) determine the feasibility of an artificial intelligence-based application (PainChek) to measure pain in people with dementia; (2) identify the optimal dosage and efficacy of a social robot (PARO) intervention; and (3) develop a checklist of cost-effectiveness measures. A sample of 45 residents with dementia will be randomly allocated to Intervention Group 1 (15-minute PARO intervention, 2×/day) or Intervention Group 2 (15-minute PARO intervention, 1×/day), or the Control Group (15-minute Plush Toy, 1×/day), for 4 weeks and follow-up at week 8. Primary outcomes include the feasibility of using the PainChek to evaluate the intervention efficacy and cost-effectiveness needs within a larger trial. Secondary outcomes are neuropsychiatric symptoms, medication use and participants’ quality of life. This novel project will improve pain management in people with dementia, and potentially reduce treatment costs.

Prospective randomised study comparing the use of a portable balance testing device prototype versus the currently available clinic-based devices in the diagnosis of vestibular disorders causing vertigo. Patients referred with undiagnosed vertigo will be prospectively randomised into either a control group which will undergo standard vestibular workup or into the interventional group which will use the portable diagnostic device. If a diagnosis is not made in the interventional group, the participant will undergo the standard vestibular workup. The portable device allows to capture the eye movements during the vertigo attacks.

Patients undergoing allogeneic stem cell transplantation frequently require enteral (nasogastric) feeding however the best formula to provide is unclear. Some research has found that the type and diversity of gastrointestinal bacteria (microbiome) may be linked to differences in health outcomes after transplant. Prebiotic fibre may assist in increasing the diversity of the microbiome and the abundance of beneficial bacteria. The aim of this pilot study is to investigate the use of a prebiotic fibre containing enteral feed and its effect on the microbiome and health outcomes after transplantation. This study will recruit 10 participants who are receiving the standard fibre free enteral feed and 20 participants to receive a prebiotic containing feed. Data on clinical outcomes will be collected as well as stool and blood samples before transplant and 2 weeks post, to assess changes in the microbiome. This research will help in improving care for future patients by increasing knowledge on the best enteral feed formula to provide after stem cell transplantation.

This 12 week trial aims to investigate the feasibility, acceptability and effectiveness of an innovative physical activity metric [Personal Activity Intelligence (PAI)] for 30 Defence force personnel and/or their immediate family following cardiac rehabilitation. Rather than counting steps, or trying to self-quantify a mix and match of different exercise types and intensities, people will have a simple target (100 Personal Activity Intelligence Score/week) that takes into account the ‘dose’ of exercise in the context of their individual body response recorded through a smartwatch. We hypothesise PAI monitoring will improve physical activity levels and intensity, general psychological well being and adherence. This approach has the potential to improve heart health and prevent long-term comorbidities and hospital re-admissions, thereby reducing healthcare costs and saving lives.

Gout is the result of high levels of uric acid in the blood depositing in the joints. It can also deposit in the kidneys and is associated with kidney disease, cardiovascular disease and death. The treatment for gout is tablets that lower uric acid in the blood stream, but most people with gout aren’t prescribed uric acid lowering therapies, or simply don’t take their medications. People with diabetes have are more at risk of developing gout than people without diabetes, due to high levels of uric acid in the blood. This study aims to identify the extent to which current diabetes medications may lower uric acid; with the hope of avoiding the need to add additional therapies to treat gout in people who already take many medicines. This is likely to increase adherence to gout therapy in people with diabetes, improving outcomes and decreasing the long term complications of gout including joint pain and death form cardiovascular disease.

The aim of this study is to investigate whether use of an imaging technique, indocyanine green angiography (ICGA), during reconstructive breast surgery after mastectomy (removal of all breast tissue) can reduce a major complication. This complication is dead breast skin tissue (necrosis) of the overlying breast skin (mastectomy skin flap). This occurs because there is inadequate blood flow to the skin resulting in breakdown. This can result in further surgery, poor cosmetic results, delay in chemotherapy or radiotherapy, and increased costs to the healthcare system. Who is it for? You may be eligible for this study if you are aged 18 years or older, are scheduled for unilateral (one-sided) or bilateral (both sides) nipple- or skin-sparing mastectomy followed by breast reconstruction. Study details Participants will receive a mastectomy and breast reconstruction using ICGA to assess blood flow to the skin flap and make adjustments such as delay reconstruction surgery or remove dying skin. Participants will return for a follow-up assessment at 7 days, 30 days and 90 days post-surgery involving a clinical assessment of the surgical site, and will be monitored for re-admission to hospital or any other complications for 12 months post-surgery. It is hoped that this study may demonstrate that the use of intraoperative ICGA in breast reconstruction surgery following mastectomy will decrease the incidence of mastectomy skin flap necrosis compared to surgery without use ICGA, which may help to reduce complications and improve cosmetic outcome.

The primary aim of this project is to examine the feasibility and efficacy of the Things You Do Intervention on anxiety, depression, and disability outcomes. The intervention encourages participants to increase how frequently they engage in a list of activities (e.g., treating self with respect, eating a healthy meal). The intervention will e delivered via a PDF lesson with text message reminders, and will be compared to a waitlist group. We anticipate that this intervention will lead to reductions in anxiety, depression, and disability.

Patients with an OPA1 mutation inherit a condition called dominant optic atrophy (DOA) which causes vision loss over time. A medication called idebenone has been shown to decrease the vision loss in patients with a similar condition, called Leber's Hereditary Optic Neuropathy, and thus this trial will investigate whether similar results can be seen in patients with dominant optic atrophy. The study will be a blinded randomised placebo-controlled study. One arm of the study will include participants with DOA who will receive idebenone, and the second arm will include participants with DOA who will receive a placebo. At the end of 12 months, the groups will be investigated to see if there is a between group difference in the rate of visual decline.

CanaCare is a clinical trial incorporating a multi disciplinary team with interventions that utilise structured physical activty under the guidance of an Exercise physiologist, a nutritional educational intervention with a registered Dietitian, and a mindfulness/meditation component. The participants are anyone involved in Cana communities, a non government organaisation that supports members of our community that experience mental health issues, substance use disorders or any other social marginalisation. The primary outcome measurement is a happiness/quality of lfe scale measured at numerous timepoints up to six months. (The Oxford Happiness Questionnaire). Public Hypothesis. The primary aim of the CanaCare program is to utilise a person-centred approach to care planning and delivery, provided in collaboration with an interdisciplinary team with the overall aim of improving the health and wellness for all participants.

Spontaneous coronary artery dissection (SCAD) is a dissection of the coronary artery with formation of an intramural haematoma or ‘false’ lumen. The resultant obstruction to myocardial blood supply leads to acute coronary syndrome (ACS) or sudden death. SCAD has a strong female predominance, with up to 90% of cases women; the majority young and healthy without cardiovascular risk factors. It is this predilection for younger women that has played a part in SCAD being universally under-recognised and under-researched. Whilst we now appreciate that SCAD is not a rare disease, the bigger problem is that we know little about how to prevent or treat it. Clinical SCAD research is urgently needed if we are to uncover more than just the tip of the iceberg in this complex and life-threatening disease. This project will pilot the first ever Australian-New Zealand Spontaneous Coronary Artery Dissection (ANZ-SCAD) Registry. 850 SCAD patients will be recruited from 10-15 hospitals across Australia/NZ with both retrospective (historical cases) and prospective case enrolment. These patients will be recruited from the study sites. Patients will be identified using their medical records and hospital admission with a diagnosis of SCAD. Background medical history (including known pre-disposing genetic conditions), cardiovascular risk factors, medications at baseline and on discharge, presentation, triggers, investigations ( i.e. scans, angiogram, including management (including revascularisation) and in-hospital outcomes. In-hospital pathology results and diabetic profiles will be collected from the medical records. For Prospectively recruited participantst follow up- information such as patients detailed family and medical history, excercise, stress pre- and post- SCAD, quality of life will be collected via questionnaires for a duration of 5 years. No follow up will be performed for retrospectively recruited participants, with all data about treatment and survival taken from medical records.