ANZCTR search results

An open trial will be used to evaluate the effectiveness of the benzodiazepine digital health program (BDZ digital health) that provides psycho-education and gradual reduction information. BDZ digital health can be accessed on multiple devices (desk top, tablet and mobile). People, who visit the website, either directly or through seeing the study advertised, will be invited to take part in the BDZ digital health evaluation study. BDZ digital health is designed to provide people with information and strategies to address their benzodiazepine use via five ‘core’ modules, plus an Introduction module. Each module will take approximately 20 minutes to complete. Participants will receive automated emails (e.g., when to complete the during, post/follow-up intervention questionnaires). During the course of the study we strongly encourage participants to work with their doctor should they decide to reduce their benzodiazepine dosage as well as seek specialist benzodiazepine telephone support from Reconnexion. Participants will complete a pre-intervention assessment (Week 0), during intervention (Week 3) assessments, a post-intervention assessment (Week 6) and a 3 and 6 month follow-up scheduled assessment (Week 18 & Week 30 respectively). Participants will continue to have access to the program until Week 38 (8 weeks following the 6 month assessment). Participants will be asked questions to ascertain reasons for engagement or lack of engagement with the program. It is expected that people who undertake BDZ digital health will show reductions in their benzodiazepine dependency, anxiety and / or depressive symptoms at post and 3 and 6 month follow-up time points.

A randomised controlled trial will be used to investigate the effectiveness of the iMindTime program. The iMindTime program will be offered through the My Digital Health platform. People visiting the website, in response to advertisements or through self-interest, will be informed of the availability of the iMindTime program and invited to participate in the study. People who consent to take part in the study will be randomly allocated to either an immediate access to the program, or delayed access (7-week delay). The iMindTime digital health program consists of six brief sessions, over 3 weeks, designed to make an individual more mindful or increase awareness of moment-to-moment experiences (e.g., thoughts, feelings, sensations) and simply accepting what is there without wanting it to change in any way. Participants will spend three days on each session before moving onto the next session. Each session will require 5-10 minutes to read and its user friendly and interactive components are designed to keep the user engaged. To consolidate learning, participants will be given activities (10-20 minutes per day) to complete offline to practise the principles of specific mindfulness exercises (i.e., mindfulness of the breath, mindfulness of body sensations, mindfulness of emotions, mindfulness of sounds, mindfulness of thoughts and loving kindness meditation) and asked to provide simple feedback on this practise at the next session. Participants will also receive automated emails (e.g., remind them to log on, when to complete questionnaires) and will be asked to self-monitor their mood and lifestyle events. Participants randomised to the iMindTime digital health (immediate access) group will complete a pre-intervention assessment (Week 0), during intervention (Week 2) assessment, post-intervention assessment (Week 4) and a 1 month follow-up assessment (Week 8). Participants randomised to the delayed access group will complete the same assessment phases and will be given access to iMindTime digital health program following the 1 month follow-up assessment (Week 8). However, the delayed access group will be asked to complete the post intervention assessment after they have completed the iMindeHealth program (Week 11). It is expected that people who undertake iMindTime immediately will show greater reductions in negative affect and increases in mental wellbeing at post and 1 month follow-up time points, relative to the delayed access group.

A transdiagnostic, cognitive behavioural and biopsychosocially-based digital health program for decreasing symptoms of anxiety and depression (called LIFE FLeX) will be evaluated. LIFE FLeX digital health is one of the digital health programs offered through the My Digital Health platform. People who consent will be given access to the LIFE FLeX program immediately but are randomly allocated to one of two groups: 1) LIFE FLeX digital health program A (immediate access to all of the program modules) and; 2) LIFE FLeX program B (weekly, sequential release of the program modules). LIFE FLeX is designed to provide people with information and strategies to address their anxiety and depressive symptoms and contains six ‘core’ modules, plus an Introduction module delivered over 7 weeks. There will also be a short ‘Booster’ Module released in Week 10. Each module will take approximately 25 minutes to complete. In addition, in order to reinforce the module-based information, there are 20-30 minutes of offline activities each week. Participants will also receive automated emails (e.g., to remind them to log on, when to complete post/follow-up questionnaires) and will be asked to self-monitor their mood and daily lifestyle events (e.g., sleep) and asked several questions at the beginning of each module, to monitor their progress. Participants will complete a pre-intervention assessment (Week 0), during intervention (Week 1-7) assessments, post-intervention assessment (Week 8) and a 1 and 3-month follow-up assessment (Week 12 & Week 20 respectively). It is expected that people who undertake LIFE FLeX will show reductions in anxiety and / or depressive symptoms at post-intervention assessment and follow-up assessment time points, as well as increases in positive affect and emotional regulation.

Preservatives in eye drops, such as benzalkonium chloride (BAK), are necessary to prevent microbial contamination, but have been known to affect the comfort and health of the eye's structures, especially if used for long periods of time. This study will investigate the impact of BAK in participants using preserved and unpreserved atropine eye drops on their ocular comfort and health, as well as on the action of the drug itself.

Bone remodelling involves a process of continuous bone resorption and formation through the co-ordinated recruitment of osteoclasts (bone resorbing cells) and osteoblasts (bone forming cells), and it is well recognised that the bone marrow provides the progenitor cells (mesenchymal and hematopoietic stem cells) needed for such processes to occur. Mesenchymal stem cells (MSCs) give rise to bone (including osteoblasts), adipose tissue and muscle, while the hematopoietic stem cells (HSCs) give rise to the blood cells (including osteoclasts). Many studies have attempted to investigate factors that regulate the bone remodeling process, with vitamin D as a popular choice due to its known beneficial effects in bone conditions such as osteoporosis in the elderly. Although its effect on osteoblasts, osteoclasts and myocytes are well known, the effects on the progenitor cells are not. Currently, the origin of osteoblastic cells is not as well understood as osteoclastic cells. With ageing, there is a significant reduction in the number and quality of the osteogenic precursors within the bone marrow, which is more prominent in osteoporotic bone. This has allowed researchers to hypothesise that increasing the number of osteoblast precursors in bone could be used as a new approach to osteoporosis. However, one of those potential therapeutic options involves an invasive and complex technique of bone biopsy with aspiration to obtain such progenitor cells for ex-vivo culturing and re-implantation for treatment in osteoporotic patients. This has led to the research of less invasive techniques that aim to assess the quality and quantity of such progenitor cells without the need of invasive procedures, with one such development being the discovery of circulating osteogenic progenitor (COP) cells within peripheral blood. COP cells are considered as a surrogate of MSC population in the bone marrow and are implicated in processes such as the pubertal growth spurt and frailty. Presently, there are few interventional studies regarding COP cells described in the literature. As such, more should be done in an attempt to explore and further characterise the biology of COP cells and their exact role in bone formation. In addition, COP cells could become a biomarker for diseases that affect MSC population, such as sarcopenia and osteoporosis, and also as an indicator of the therapeutic response to treatments that induce bone formation. There have been many studies recognising various compounds that affect bone. Vitamin D is one of those compounds with an anabolic effect on bone and also as an inhibitor of bone marrow adipogenesis. In this study, we hypothesise that individuals who are deficient in vitamin D will have a relatively lower number of COP cells as compared to healthy individuals. Secondly, we also hypothesise that the beneficial effect of vitamin D supplementation on human bone is associated with increasing numbers of COP cells.

The primary aim of this pragmatic study was to explore the role of an intensive care diary in the ICU, particularly with reference to the logistics of recruitment, potential acceptance of diaries amongst our patient population and it’s impact on anxiety, stress and depression. The secondary aims of the study were to ascertain if there was an association between provision of an ICU diary and PTSD symptoms which could then provide baseline profile for future hypothesis testing on its impact Ethical approval for this study was obtained from the Royal Adelaide Hospital Human Research Ethics Committee HREC reference number: HREC/15/RAH/48 RAH Protocol No: 150216

The current study aims to explore the benefits of a brief reminiscence task on mood for older adults living in residential aged care. The reminiscence task involves remembering past positive memories and recalling past experiences where the participant had to solve a problem. Previous research with community samples suggests that thinking about these meaningful experiences leads to improved mood and feelings about the future and oneself. Research has not yet investigated if positive outcomes occur for older adults living in residential aged care.

Sulforaphane is a naturally occurring compound belonging to the isothiocyanate group. It can be obtained naturally through cruciferous vegetables with broccoli sprouts being one of the richest sources. Sulforaphane obtained through ingested broccoli sprouts are activated by myrosinase, a chemical that is released by chewing of the vegetable. Myrosinase is also present in the gut flora of individuals and mediates the conversion of pre­cursor compound to bioavailable Sulforaphane. Previous studies in humans has demonstrated the anti­oxidative, anti­inflammatory effects of Sulforaphane and its ability to protect against endothelial dysfunction and end organ damage. Therefore, we believe Sulforaphane may have a potential clinical utilitity in maternity care as a ‘low risk’ intervention for the treatment of pre-­eclampsia. The aim of the research project is to evaluate the pharmacokinetics (PK) of sulforaphane obtained through the ingestion of two different natural broccoli sprout supplements in a healthy cohort of subjects n=6. Participation involves the ingestion of each of the two different supplements with associated PK blood sampling at 8 pre-determined time points, one just prior to ingestion and then following at: 15, 30, 60, 90, 120, 240 and 480 minutes intervals. The study is an open-label, crossover design, with a two week ‘wash out’ period, between taking the first supplement and the second (different) supplement.

The use of diuretics in critically ill patients is widespread. Indications include the management of volume overload, maintenance of acid-base balance and potassium homeostasis. Commonly used diuretics include frusemide and acetazolamide. Despite the common use of these drugs there is no high quality evidence available comparing the effect of these drugs on the haemodynamic status and metabolic status of critically ill patients. We aim to evaluate the comparative effect of a standard dose of intravenous frusemide vs a standard dose of acetazolamide in critically ill patients. We plan to enrol a total of twenty-four patients in whom a decision has been made to administer a diuretic. These twenty-four patients will then be randomly assigned to receive a single dose of either frusemide of acetazolamide. To understand the effect of the diuretic administration, we will retrieve routinely recorded patient demographic data, haemodynamic data (such as blood pressure, heart rate, central venous pressure and cardiac output), data from the arterial blood gas samples (serum creatinine, sodium and potassium) as well as urine from the patient’s existing indwelling urinary catheter. The results of this study will provide insight into the effects of these two diuretics on electrolyte imbalances and the haemodynamic status of critically ill patients.

Low rates of psychosocial service use (e.g., helplines or support programs) are well documented, especially for rural men affected by cancer. Developing targeted information specifically for this group has previously been suggested as a way to provide information on psychosocial services, and address the barriers to using services. However, theory-based informational resources for rural men affected by cancer have not previously been objectively developed or tested. This trial aimed to develop targeted rural- and targeted rural male-psychosocial service information brochures. Specifically, the trial examined the effectiveness of such information in increasing how personally relevant the information is seen as, and attitudes to seeking help and intention to use services after reading one version of the brochure. Targeted versions of an existing Cancer Council SA brochure were developed based on psychological theory. Participants viewed one copy of the brochure in a randomised fashion (either the existing version, or the targeted rural- or rural male-version). Participants completed questionnaires before, immediately after, and approximately 24 hours after viewing a brochure. N = 114 rural men affected by cancer were recruited via supportive accommodation facilities, Ninety participants returned all questionnaires and were included in the final analyses. Results showed that attitudinal or behavioural measures between the three brochure groups were not significantly different. Participants reported that they primarily sourced service information from other people (friends, family, medical professionals, others). Notably, existing service use was high in the sample or participants, reflecting the recruitment methods, and therefore increasing awareness of services may have been particularly challenging. There was no evidence that targeting rurality or gender improved attitudes to service use in this trial. Further qualitative research to build understanding about the acceptability of various targeting techniques in this population would be useful, as would replicating this study in a sample not recruited via a Cancer Council SA service.