ANZCTR search results

Participants of ACTRN12621000076875 were allocated a specific nicotine replacement product (vaporised nicotine product or oral nicotine replacement therapy [nicotine gum or lozenge]) at baseline. This observational extended follow-up study investigates participants that successfully quit smoking (met trial primary outcome) in ACTRN12621000076875, Participants will be followed up at 19 months to determine long-term smoking abstinence, as well as examine patterns of long-term use of nicotine products. Participants may be asked to provide a salivary sample for cotinine analysis and complete a carbon monoxide breath test.

We are conducting this online trial to determine if different diagnostic labels and their explanations impact consumer beliefs about hip pain and its management in adults who have had and have not had hip pain. It is unclear how diagnostic labels of chronic hip pain and their explanations impact beliefs about treatments of hip pain. Qualitative literature links pathoanatomically framed diagnoses and information about hip with the belief that exercise is potentially harmful and that surgery is necessary to fix or cure hip pain. However, these findings are yet to be confirmed by an experimental study. This study will thus aim to determine the effects of three diagnostic labels on consumer beliefs about hip pain and its management: 1) hip osteoarthritis, with a modern explanation; 2) chronic hip pain, with a psychosocial explanation of pain; 3) hip degeneration, with a pathoanatomic explanation. The trial will be administered in one single online survey. Participants will initially answer screening questions to determine eligibility. All eligible participants will then read the same hypothetical hip problem, and then complete baseline outcome measures before being randomly allocated to one of the three diagnostic label groups. After reading the diagnostic label and explanation they were assigned, all participants will complete the outcome measures again.

The aim is to perform a randomised, double-blind, inactive-comparator-controlled trial of vitamin C and zinc for the treatment of foot ulcers in people attending multi-disciplinary high-risk foot ulcer clinics. Our overall hypothesis is that treating people who have chronic foot ulcers with vitamin C and/or zinc will improve ulcer healing and thereby improve quality of life, prevent osteomyelitis, decrease amputations and will be safe, highly cost-effective and widely implementable. Patients will be treated for 8 weeks and followed up until complete ulcer healing, amputation, or a minimum of 12 weeks if not fully healed before. Patients will have a blood test for serum vitamin C and zinc at baseline, accompanied by any usual tests required by the foot ulcer clinics. After this baseline visit, patients will otherwise have usual care at the foot ulcer clinic, except for taking their assigned tablets. After 4 weeks their blood results for zinc and vitamin C will be made available. If deficient, they will receive both tablets for their deficiency. This will ensure we offer all people who are identified as deficient treatment but maintain blinding to their original 4 weeks of treatment. At 8 weeks or the closest visit, people will have their blood vitamin C and zinc re-tested. They will then be followed until complete ulcer healing, amputation or a minimum of 12 weeks if not healed before.

One in 10 patients in an Australian hospital acquire an infection while in hospital, often referred to as a healthcare associated infection (HAI). The burden of HAIs is significant, with associated morbidity, mortality and, for those acquired in hospitals, increased length of stay. However, there is little high quality research into the role of environmental cleaning to reduce HAIs. A seminal Australian study published in 2020, conducted in 11 hospitals (REACH study, ACTRN12615000325505), demonstrated improvements in routine hospital cleaning being associated with a reduction in infection. The REACH study did not, however, focus on the cleaning of shared medical equipment. Another Australian study has provided molecular evidence, that shared medical equipment plays a critical role in the transmission of infection. The proposed study builds on these study findings, and focuses on improving the cleaning of shared medical equipment as a key strategy in the reduction of HAIs. The hypothesis for this study is that improving the frequency and quality of cleaning for shared medical equipment, will reduce the risk of infections being acquired in hospital.

This study aimed to understand whether using behaviour change techniques relating to perceived risk and habit could improve safe food-handling behaviours, perceived risk, and habit.

Traditionally, surgeons undertaking THA have performed a distal neck osteotomy, which invariably necessitated the excision of healthy bone. The introduction of bone-conserving short-stem implants has shown there is a growing body of evidence to suggest that retaining the femoral neck can provide mechanical and biological advantages. One of the aims of successful THA is to restore this environment to its native state. Following surgery, femoral components are subject to high torsional and shear forces that can precipitate implant movement. Torsional stability is known to be an important factor in implant fixation and can influence survivorship. The prostheses are also subjected to vertical forces that can produce interface micro-motion or result in migration of the stem into varus. It is argued that neck preservation offers superior tri-planar implant stability and allows more accurate restoration of the hip biomechanics. Medacta International have recently developed a new short femoral stem device designed for use in total hip arthroplasty. The femoral stem is one component of a total hip replacement. The MPRES femoral stem is not yet approved by the TGA however, Medacta International has obtained European CE Mark Approval. CE Marking allows Medacta to supply the MPRES device in the European Union (EU). The MPRES is a Neck Sparing Stem, as it is designed to be bone conserving. It has been designed as a primary uncemented femoral stem for use in total hip arthroplasty. The design intent on the MPRES stem is to provide a THA that preserves healthy bone stock and allow for minimal invasive surgical approaches. The MPRES is a cementless, biplanar, wedge-shaped monoblock stem of Titanium Alloy and hydroxyapatite coating. It is currently unknown if the new MPRES cementless femoral stem device has noninferiority revision rates in comparison to all other on-market femoral stems. The purpose of this study is to assess the safety and performance of the MPRES. This will be achieved by both assessing the survivorship data and collecting patient reported outcome measures from patients who are having the MPRES device.

The SCARF study will be an observational prospective study conducted over a period of three years.Our primary endpoint is the development of SCAF in these participants defined as ‘the incidence of asymptomatic atrial fibrillation’, lasting at least 30 seconds, as diagnosed by a AliveCor KardiaMobile ECG [AliveCor Inc., Mountain View, Calif, US], and previously not documented during the clinical history of the participants. Our primary endpoint is defined as ‘SCAF’ and will be assessed across 10 haemodialysis sessions using 6-lead ECG monitoring via the KardiaMobile device of the enrolled study participants (at beginning of haemodialysis session, at 1.5 and 2.5 hours into the haemodialysis. and at the end of the haemodialysis session). Additional ECGs (via the Kardia Mobile device) will be taken should the participants complain of palpitations during the haemodialysis. Should AF be detected on the basis of symptoms in these participants, it will be defined as “Symptomatic Atrial Fibrillation”. Participants enrolled in the study will be on regular maintenance haemodialysis, therefore we plan to screen participants for at least 10 haemodialysis sessions to increase the sensitivity of detecting SCAF. Secondary endpoints will be assessed using data collected from clinical records, the administration of widely used cognitive test, via the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).

This is a non-interventional multi-site observational study intended to record data from the real-world use of cannabidiol medicines for treating pain and/or stress across Australia. The study treatments being comprised of botanical extract CBD (MC-1020) and synthetic CBD (MC-1023), which are delivered as oro-buccal sprays

The Anti-Mullerian hormone (AMH) test is currently being promoted misleadingly by online companies and fertility clinics as a fertility test for women. Importantly, research has demonstrated the test is not predictive of current or future fertility potential. It is vital women receive evidence-based information about this test free from commercial interests in order make informed decisions regarding their reproductive planning. This study aims to co-design an evidence-based information guide with key stakeholders (clinicians and consumers) and evaluate it with two samples of women, living either in Australia or The Netherlands. The information guide will be tested using an online randomised experimental design to assess the impact of the information on women’s intention to have the test, knowledge about AMH, attitudes towards the blood test and psychosocial outcomes. Hypothesis: It is hypothesised that women who receive the intervention (evidence-based info) will have lower interest and intention in getting an AMH test, and have higher knowledge, than women who receive the control information (misleading information currently online). Potential significance of the current study: Given the plethora of misleading information about the AMH test online, this study will produce crucial, evidence-based information for consumers, with the goal of improving informed decision-making and reducing inappropriate test usage.

This study investigates two different treatment schedules for an existing evidence-based speech pathology treatment (Dynamic Temporal and Tactile Cueing, DTTC, Strand, 2020) for children with Childhood Apraxia of Speech (CAS). DTTC is one of the few treatments with demonstrated efficacy for CAS (Murray et al., Maas et al., 2014). DTTC has previously been researched in high-intensity contexts, with therapy across 3-5 days per week (e.g Maas & Farinella, 2012; Strand & Debertine, 2000). DTTC involves watching the clinician and receiving tactile cues and is only suitable for in-person treatment. For families, particularly those in rural and remote areas, attending sessions 3-5 times/ week is not practical (Dew et al., 2012). This study will investigate two different session frequencies (3 times/ week and one 3-hr session/ week) while maintaining cumulative intervention intensity at 24 hours of therapy across 8 weeks. The quantitative data about the child's speech outcomes will be supplemented with qualitative information collected via semi-structured interviews with families and clinicians. The quantitive data will be collected using a Multiple Baselines Across Participants design, with 3-5 baseline sessions, 3 treatment phase probe sessions and 3 follow-up sessions (1-day post, 1-week post, 4 weeks post and 3 months post). The probe data set will include each child's individualized 20 treatment items and a 42-item generalisation probe (common to all children). The primary outcome measure is the whole word accuracy (including segmental and prosodic accuracy) and secondary outcome measures include percentage of consonants correct (PCC), % lexical inconsistency (as measured by the Inconsistency Severity Percentage, Iuzzini-Seigel, 2017), intelligibility (as measured by the Intelligibility in Context Scale, McLeod et al, 2012), and functional outcomes (As measure by the functional outcomes in children under six (FOCUS 34, Thomas-Stonell). The qualitative data will be collected using semi-structured interviews with carers and clinicians to explore perceptions of session length and frequency on the ease of therapy and the ability to accommodate therapy with other priorities. The qualitative data will be analysed using reflexive thematic analysis. (Braun & Clarke, 2020)