ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31276 results sorted by trial registration date.
  • The MIDY pilot trial (Mobile Intervention for Drinking in Young people)

    Our proposal is to take brief interventions, proven to have a significant impact on young people's drinking, and apply them in the mobile realm during actual drinking occasions. The intervention will consist of hourly mobile assessment and feedback. While on a night out, participants will receive hourly reminders to complete a very brief questionnaire through an online survey accessed via the SMS message. The questionnaire will involve hourly reports of their alcohol consumption and spending, where they are, and their mood. They will then receive an individually tailored feedback message via SMS in response to these data, which aims to stop or slow down their drinking, or avoid harmful consequences of drinking. The intervention will be delivered on 6 drinking occasions (nights) over a 12 week period. This study aims to determine the impact of a tailored brief intervention delivered by mobile phone on young people's high-risk alcohol consumption. We will use a randomised controlled trial design to generate high quality evidence of the impact of this intervention on single occasion risky drinking among young people. This will be the world's first randomised controlled trial of a mobile delivered brief intervention to reduce alcohol consumption.

  • The Healthy Brain Ageing E-Health Platform: Validating Online Strategies to Recruit and Assess Older Adults at Risk of Cognitive Decline

    As there are no effective cures for dementia, it is essential that efforts focus on screening for potentially ‘modifiable risk factors’ of cognitive decline as it has been estimated that reductions in these treatable conditions could result in 1.1 million fewer cases of Alzheimer’s disease worldwide. These ‘modifiable risk factors’ include depression, diabetes, having high blood pressure, being overweight, being a smoker, being physically inactive, and having low education which in turn relates to not keeping the brain active enough. The internet is a powerful means by which to prevent health-related problems and to promote general health and wellbeing on a large-scale, referred to as ‘e-health’. E-health can be used to screen ‘at risk’ individuals, offer self-help through online interventions or deliver proactive and guided interventions facilitated by expert clinicians. The major advantage of e-health over standard models of care is the ability to recruit and deliver interventions on a large-scale, thereby being able to more effectively address major public health issues. Our team has developed a large scale “Healthy Brain Ageing” (HBA) e-health platform designed specifically for older adults who are ‘at risk’ of cognitive decline and dementia. Our goal is to establish a register of ‘at risk’ individuals with ongoing monitoring of cognition as well as potentially modifiable risk factors for cognitive decline, with a view to providing targeted interventions as appropriate. Prior to implementing this system, we seek to confirm that we can successfully recruit older adults ‘at risk’ of dementia via the HBA e-health platform. Additionally, we aim to establish that the assessment tools used in the e-health platform accurately screen for age-related cognitive impairment and correctly identify an individual’s dementia risk factors relative to gold-standard clinical assessment tools conducted in a face-to-face clinic setting. We will invite 1500 people from across NSW aged 50-70 years to complete an online screening questionnaire as well as a brief battery of online neuropsychological tests (Cogstate). Subsequently, a subsample of 180 participants with varying levels of cognitive impairment and/or modifiable risk factors will be invited to attend one of three assessment sites for detailed neuropsychological, medical, and psychological assessment. We will compare the results of these two evaluations to ensure that the online assessment tools are sensitive to dementia risk factors and cognitive decline (i.e., equivalent to standardised assessment tools used in clinical practice). Additionally, feasibility of recruitment will be assessed based on our ability to meet recruitment targets in specified project timelines.

  • Does attention bias predict which pain patients benefits from mindfulness and distraction

    This study aims to determine (a) whether a mindfulness interoceptive exposure task is more efficacious than distraction and no treatment for people with chronic pain problems; and (b) whether attentional bias towards pain-related stimuli moderates the efficacy of mindfulness versus distraction. Participants with chronic pain problems will be randomized to receive one of two active interventions (either mindfulness interoceptive exposure or distraction) or a control condition. Prior to the single-session intervention, those in the active intervention groups will complete a measure of attention bias using the dot-probe with eye tracking technology at the beginning of a single-session intervention. Participants will then complete the intervention within the session and be asked to practice at home. Participants will complete a assessment of attention bias (and self-attention check; as well as pain ratings) immediately before and after the intervention is administered. They will then be asked to practice either the mindfulness or distraction task for two weeks, before completing the outcome questionnaires. The primary outcome point for the intervention is two weeks after the intervention is administered, except for disability where it is anticipated positive outcomes will not be seen until three months post-intervention. Measures will be given at pre-treatment; post-treatment (i.e. two weeks); one, three and six months later.

  • The effect of manual therapy and exercise on age-dependent lung function: a randomised controlled trial.

    Ageing is associated with a range of anatomical and physiological changes that include the respiratory system. These changes begin as early as 40 years of age and include stiffening of the spine and chest wall. This stiffening has an impact on breathing mechanics and is a cause of the progressive decline in lung function typically associated with ageing. The aim of this trial is to investigate whether reducing stiffness in the spine and chest wall improves lung function in people over 50 years of age. The trial is designed as a randomised controlled trial with 306 healthy people between the ages of 50 and 65 years randomly allocated to one of three equal groups. Group 1 (Control) will receive a standardised exercise program performed on a treadmill. Group 2 will receive a mobilisation protocol designed to increase joint mobility in the thoracic spine and ribs followed by the same exercise program. Group 3 will receive a manipulation protocol designed to increase joint mobility in the thoracic spine and ribs followed by the same exercise program. Each participant will receive six intervention sessions over a period of three weeks. Outcome measurements will be taken by assessors who are unaware of the group a participant has been allocated to. They include non-invasive lung function measurements, chest expansion and a respiratory function questionnaire. These measurements will be taken on four occasions: before the first intervention (baseline), at the end of the intervention period (3 weeks), and then at 3 and 6 weeks post-intervention (i.e. in the 6th and 9th weeks of the trial). The last two measuring points are designed to assess whether the effects of intervention are ongoing. Lung function will be measured using spirometry (exhaling into a tube) and chest expansion measured using a tape measure. It is expected that manual therapy plus exercise will improve lung function more than exercise alone. It is also expected that improvements in lung function will be different for the two manual therapy interventions.

  • Therapy intervention and imaging utilisation patterns for patients over the age of 50 presenting to a chiropractic teaching clinic.

    An audit of all consultations for patients 50 years and over spanning 2005-2010 was undertaken. Management of patients was categorised according to treatment delivery (yes/no); treatment type (passive care with/without SMT); spinal region (cervical/thoracic/lumbo-pelvic); whether imaging was obtained (yes/no); image timing (prior to care yes/no); and imaging centre (MUCC/external). This study aims to quantify the imaging patterns and practices at a chiropractic teaching clinic and its significance with respect to spinal manipulation. The use of imaging within the chiropractic profession is the subject of significant debate, and especially the question of whether spinal manipulation should be performed in the absence of spinal imaging of the relevant spinal region. There has been, to date little data on the actual frequency of the use of imaging for patients undergoing chiropractic care. Whilst there is not universal agreement as to the significance of age, it does constitute an ideal starting point, a baseline to quantitatively measure imaging behaviour in a clinical setting. This study sets out with the primary clinical question; "How often do students at a chiropractic teaching clinic view images of the region being treated with high velocity low amplitude (HVLA) manipulation of the spine if the patient is age 50 or greater?" A second question is; "If images were viewed, were they obtained prior to HVLA treatment?" Finally "If images were obtained, were they performed on campus or externally, or both

  • Microporous Polysaccharide Hemospheres (MPH) and Seroma Formation After Mastectomy and Sentinel Node Biopsy/Axillary Dissection

    The primary purpose of this trial is to investigate whether the use microporous polysaccharide hemosphere (MPH) reduces the rate of seroma formation in breast cancer patients following mastectomy. Who is it for? You may be eligible to enrol in this trial if you are aged over 18 and have been diagnosed with breast cancer for which you are scheduled to undergo a mastectomy with or without sentinel lymph node biopsy, and with or without axillary lymph node dissection. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either MPH or no MPH applied to the wound prior to wound closure. All participants will be followed up at 2 weeks following surgery to assess the wound site for seroma (fluid pockets). It is hoped that this trial will provide information on whether MPH is effective in the prevention of seroma in breast cancer patients following mastectomy.

  • Efficacy of two splint treatment protocols of tendinous mallet finger Injuries

    Specialised Hand Therapy Services is conducting research in conjunction with Edith Cowan University into outcomes following treatment of tendinous Mallet finger injuries. The aim is to determine whether long term outcomes can be improved by providing an additional splint to the usual standard splint protocol that is currently used. The project is being conducted by Taryn Post, Jessica Mirabile, Cathy Thomas and staff at Specialised Hand Therapy Services and also with Dr. Janet Richmond from Edith Cowan University. This project will help us find out if positioning the finger differently (i.e. with the PIP joint in flexion as well as the DIP joint in extension/hyperextension) improves results/ outcomes for our clients. We are currently evaluating the protocol and splint type that we use for the treatment of acute tendinous mallet injuries. We are collecting data and evaluating the outcomes to better aid in the protocol that we use in the treatment for these diagnoses. We wish to study whether an additional splint that keeps the PIP (middle) joint of the injured finger in a slightly flexed (bent) position while wearing the splint for the injured DIP (end) joint improves long term outcomes and results with conservative/nonsurgical management of Mallet finger injuries.

  • Plasma lipoproteins in coronary artery disease.

    In this prospective observational study, we are investigating the association between blood proteins (beta-2-glycoprotein I, Apo B100 and HDL) and coronary artery disease as well as complications after percutaneous coronary intervention (stenting or ballooning) and late graft failure after coronary artery bypass grafting.

  • Impact of resistance training on androgen deprivation-induced adverse effects on protein metabolism, body composition and muscle function in prostate cancer patients

    The primary purpose of this trial is to investigate the efficacy of progressive resistance training for reducing the side effects of loss of muscle and increase in fat associated with androgen deprivation therapy (ADT) for men with prostate cancer. Who is it for? You may be eligible to enroll in this trial if you are aged 50-80 years and have been diagnosed with prostate cancer for which you are scheduled to receive ADT by a GnRH agonist. Study details All participants enrolled in this trial will be randomly allocated (by chance) to either the progressive resistance training group or the control group, who receive no training. Participants in the progressive resistance group will receive self-managed structured 40 minute resistance exercise regimen using dumbbells 3 times a week for 12 months. It is hoped that this trial will provide information on the efficacy of progressive resistance training for reducing the loss of protein, muscle mass and function associated with ADT in prostate cancer patients.

  • Local anaesthesia for transperineal prostate biopsy – a randomised control trial

    This study aims to determine whether the infiltration of local anaesthetic following transperineal prostate biopsy significantly reduces pain scores as determined by VAS and short McGill pain questionnaire. Who is it for? You may be eligible to join this study if you are a male aged 50 years or above and are undergoing transperineal prostate biopsy. Study details Men will be allocated into 2 groups by chance, a treatment group and a control group. Men in the treatment group will receive infiltration of local anaesthetic (20mls of 0.5% bupivacaine) into the perineal skin after prostate biopsy. Men in the control group will receive no intervention. Data to be collected will be VAS and short McGill pain questionnaire forms 30 minutes following the procedure (to be filled out by the patient). The design of this study (RCT) will enable data collection and analysis to determine whether or not infiltration of local anaesthetic at the time of transperineal prostate biopsy is effective. That is, does it reliably reduce pain scores (VAS and short McGill pain questionnaire) and are the results statistically significant.

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