ANZCTR search results

Our recent systematic review showed that both volitional and reactive step training reduce falls by approximately 50% in healthy older adults. Our recently completed randomized control trial (RCT) confirmed safety and effectiveness of home-based volitional step training in people with Parkinson’s disease (PD). We hypothesise that a combination of volitional and reactive step training will provide additional benefits, underpinned by differential motor control mechanisms of action. This is a single blind RCT using a parallel arm design including a 12-week intervention, pre- and post-intervention assessments and 6-month follow-up for falls. Our RCT will be the first to clarify the effectiveness of combined volitional and reactive step training on risk of falling in people with PD using state-of-art technology.

The purpose of this study is to assess whether skin or wound repair using ‘ablative laser resurfacing’ assists in reducing sun-induced mutations and therefore reduces the number of non-melanoma skin cancers. Who is it for? You may be eligible for this study if you are over the age of 45 and have had more than 10 non-melanoma skin cancers in your life. Study details Consenting participants will have three 2.5 x 2.5cm patches of skin devoid of skin cancer identified on one forearm. Participants will then receive ablative laser resurfacing to two patches of skin. The third patch of skin will not receive any treatment This treatment will be performed at the Princess Alexandra Hospital. After 3 months, a biopsy of the three patches of skin and a saliva sample will be taken for assessment. It is hoped that this research will show that ablative laser resurfacing reduces the amount of skin mutations and thus may reduce the chance of skin cancer formation.

This pilot randomised trial, will evaluate the effect of participating in Strength Training (ST) with Peer Support (PS) compared to ST participation without PS. The project will be conducted in collaboration with the Council on The Ageing – COTAWA and Amana Living. All exercise participants will receive an individualized ST program in their home, prescribed by a qualified physiotherapist. The peers will receive peer training (2 hour session), meet the ST participant in a face to face meeting and then phone their ST participant once a week to provide encouragement and motivation. It is hypothesized that ST participants with a peer will be more likely to continue with a ST program after the completion of the 12-week intervention than those with no peer support.

IgAN is a serious, progressive disease in which 20% to 40% of patients progress to end-stage renal disease (ESRD) within 10 to 20 years of diagnosis. As most patients are diagnosed in their 20s or 30s, they face the prospect of dialysis or the need for kidney transplantation in the prime of their lives. The purpose of the study is to analyse the change in the urine protein/creatinine ratio (UP/C), based on a 24-hour urine sample at Week 36, when comparing sparsentan to irbesartan. Patients enrolled in the PROTECT study (Protocol 021IGAN17001) will be randomly assigned in a 1:1 ratio (like flipping a coin) to sparsentan or the active control (irbesartan) at the Day 1/Randomization visit. Study medication (sparsentan and irbesartan) will be administered as a single oral morning dose. The hypothesis to be tested relates to the change in proteinuria (protein in the urine) at Week 36 for sparsentan compared to irbesartan.

The current vaccination rates for Australian children under the age of five are below the national target of 95% coverage, which is required to achieve herd immunity. Herd immunity is a pattern of immunity where the risk of an individual contracting an infection is reduced by having vaccinated or immune individuals surrounding them, hence protecting against infectious diseases such as measles and smallpox. The low vaccination rates can be attributable to vaccine hesitancy which is the delay in acceptance of a vaccine despite availability. This behaviour occurs on a spectrum and is influenced by various factors. A novel way to reduce vaccine hesitancy is by implementing strategies informed by the field of behavioural economics through SMS technology. This single blinded randomised controlled trial will enrol up to 274 new parents from King Edward Memorial Hospital. Participants will be randomised into two groups, both receiving a vaccine hesitancy survey before and after the intervention (an SMS reminder.) The outcome will be measured through a change in the vaccine hesitancy score, calculated from survey responses. The primary objective of this study is to examine the effect of negative SMS vaccine reminders on vaccine hesitancy in new parents.

A multi-center, double-blinded, randomized, placebo-controlled, single ascending dose study and multiple ascending dose study to investigate the safety, tolerability, pharmacokinetic, pharmacodynamic, and hemostatic profile of VE-01902. The single ascending dose phase will encompass a single bridging cohort across tablet strengths, and a food effect cohort.

Anxiety is under-examined in Parkinson's disease (PD) patients, yet it is a major contributor to a poor quality of life in this population. Our previous study aimed at improving diagnosis and treatment of anxiety in PD was the first to pilot Cognitive Behavioural Therapy (CBT) for anxiety in PD using a tailored, manualised and dyadic protocol involving both PD and carers. This project develops and tests CBT incorporating Virtual Reality (VR) proposed to augment anxiety treatment in PD. VR environments (in virtuo experiences) have the potential to improve the efficacy of CBT treatment with the following unique benefits: • Patients are not required to mentally reproduce the stimulus as in imaginal exposure and relaxation. This is an issue in persons with PD, as executive function and memory retrieval are often impaired even at early stages of the disease. • Multi-sensory engagement provides a tangible and ‘real’ experience, improving patient engagement in the therapy. • The environment can be tailored by the clinician based on the subcategory of anxiety. • Relaxation immersive VR (eg: Virtual Meditative Walk) assists patients to focus attention inward which is advantageous in a population of patients with compromised attention. • Current smart-phone technology is capable of running VR software to allow for home based remote delivery of VR therapy. A randomised waitlist controlled feasibility trial will be conducted comparing the new CBT-VR to treatment as usual in reducing anxiety in PD (primary outcome). Secondary outcome measures will be depression, sleep, quality of life, and outcomes for carers. The manualised CBT-VR package will comprise of eight weekly sessions of 90 minutes each conducted at the University of Queensland. Additionally, patients will be given a mobile device with headsets for VR view at home with relaxation VR applications and a smart watch for monitoring of anxiety via heartrate. Basline, post and 3 month follow-up data will be collected.

This clinical phase 2 proof-0f-concept study will test the safety and efficacy of NRP2945 in a placebo-controlled fashion within 5 patients diagnosed with drug-resistant absence epilepsy. It is hypothesized that NRP2945 will diminish in quick succession the frequency of drug-resistant absence seizures in patients through the stimulation of inhibitory neural networks in the brain. The formation of inhibitory neural networks are the prerequisite for re-establishing normal neural activity networks in said patients. This potential outcome will be measured through EEG analysis and a potential improvement of quality of life measures will be assessed by questionnaire during the follow-up visit.

Touchscreen tablet technology (including iPads), provide diverse opportunities for people with dementia to engage in personally meaningful activity. However, a ‘one size fits all’ approach, which focuses on applications designed for a particular population, cannot adequately address barriers to engagement in meaningful activity for people with dementia. The aim of this study is to test the hypothesis that personalized iPads will be more efficacious than treatment as usual for 1) slowing the pace of decline in dementia, 2) maintaining functional performance, 3) decreasing the occurrence of behavioral and psychological symptoms of dementia; and 4) improving quality of life. 1) maintaining dementia severity; 2) maintaining functional performances; 3) decreasing the occurrence of neuropsychiatric symptoms; and 4) improving quality of life, for people with dementia living in residential care. This study will use a feasibility pilot randomized controlled trial design, where the unit of randomization will be individual residents. The findings of this study will make a significant contribution to inform efforts by all residential care staff to support the health, wellbeing and quality of life of residents with dementia.

Hidradenitis suppurativa (HS) is a long-term, inflammatory skin condition of unknown cause affecting the sweat/scent glands in the skin, predominantly located in the groin, axillae and under the breasts. Patients can experience painful boil-like nodules in addition to discharging wound tracts which are difficult to heal. Consequently, this HS can cause severe long-term pain in addition to serious psychological effects such as depression, anxiety and social withdrawal. HS severity is graded according to the Hurley system which calculates a grade based on the numbers of inflammatory nodules, in addition to the presence of sinus tracts and abscesses. To manage their symptoms, many patients require immunosuppressant medications and extensive surgery to remove the affected tissue. In such cases, application of topical medications as well as effective dressings can be a challenge. To date, specialised nurse-led education programs have not been trialled in cases of HS, despite their proven benefit in other dermatological conditions. This pilot study aims to evaluate the efficacy of a personalised dermatology-led education program for patients with hidradenitis suppurativa. Participants will be allocated randomly using a randomisation sequence generated by Microsoft Excel using random block sizes of two (2). Randomisation and allocation of participants will be performed by the dermatology nurse who will be administering the education sessions. Allocations will be concealed from the researchers who will be analysing the collected data. Participants allocated to the intervention group will be provided with the education session whilst participants allocated to the control session will not receive any additional education. At the 8-week mark of the project, the groups will switch so that the participants initially allocated to the control group will then be provided with the education session. Nil further education sessions will be provided to the (original) intervention group. Intervention: The intervention employed in this project is a nurse-led education session provided by a highly experienced dermatology clinical nurse, to take place in the dermatology outpatient department at Princess Alexandra Hospital. The sessions will be individualised to each participant but, in general, will provide education about: • The nature of the condition • Effective application of topical medications and dressings (with demonstration) • Modification of lifestyle factors known to contribute to hidradenitis suppurativa severity (eg weight loss and smoking cessation) • Pain management Each session will take an estimated 45-60 minutes and participants will be offered the opportunity to contact the dermatology nurse 4-6 weeks later to address any questions or concerns that have arisen. The sessions will not be recorded.