ANZCTR search results

This is a prospective, blinded, randomised controlled feasibility trial of critically ill tube fed ICU patients looking at the effectiveness of diabetes specific nutritional formula in managing stress hyperglycaemia. The primary aim of this study is to determine whether the administration of a diabetes specific formula, when compared to standard enteral formula, reduces insulin use over a 48 hour period. Secondary outcomes include both clinical endpoints and assessment of the feasibility of study processes to inform a potential multi-site RCT. A sub-study will also be incorporated to determine if altered carbohydrate, is associated with a change in oxidative stress markers, as well acute and chronic inflammatory biomarkers.

The primary aim of this group randomised control trial is to evaluate the impact of an innovative multi-component intervention to reduce sedentary behaviour (i.e. time spent sitting) on health and psychological well-being in adolescents. The project will address the following research questions: i) What is the impact of the intervention on the primary outcome of recreational screen-time? ii) What is the impact of the intervention on the secondary outcomes of psychological wellbeing, obesity, physical activity and sleep time? iii) What are the factors responsible (i.e., mediators) for sedentary behaviour change? iv) What is the feasibility and acceptability of the intervention among students, parents and teachers? The study will include a range of different strategies including: (a) e-Health delivered intervention messages and an, (b) Information session. The intervention will also include a range of strategies for parents to manage their children’s screen-time: (c) screen-time behavioural contract, and (d) newsletters focusing on household screen-time rules, consequences of excessive screen-time, strategies to manage parent/child conflict arising from screen-time rules and home challenges to reduce screen-time. Recreational screen-time will be the primary outcome of the study. Secondary outcomes include: psychological well-being, physical self-concept, psychological distress, weight, height and physical activity. Social cognitive and environmental mediators of sedentary behaviour change will be also be assessed. Assessments will be conducted at baseline and 6-months.

Participants will be provided with placebo film (equivalent in number to their usual Suboxone film dose denomination) and will be asked to try to remove the film following its administration sublingually. This will be repeated at various time points following administration (ie. 15 seconds, 30 seconds and 1 minute), under 2 different conditions. That is, the adherence of the film in the mouth (and subsequently ability to remove the film(s)) will be explored when multiple films are stacked as well as when spaced.

Background: The neck muscles support and protect the neck and normally are activated as soon as arm muscles are activated when we move our arms. However, the onset of the neck muscles including the deep and superficial neck flexor muscles in comparison to the onset of deltoid muscles (relative latency) is delayed in people with neck pain relative to pain-free individuals. In a previous study it was shown that the relative latency of the onset of the deep neck flexors was improved by a specific low load neck exercise, which was practised for six weeks. However, the relative latency of the onset of deep neck flexors remained delayed in comparison to asymptomatic subjects. This was interpreted to indicate a persistent deficit in timing of activation of these muscles. We therefore question whether the onset of the neck muscles can be further improved to match that of pain-free individuals if the exercise is continued for a longer time. This information is very important for ideal prescription of exercises for people with neck pain and could be relevant for prevention of further episodes of neck pain. The purpose of this study is to investigate whether the onset of activation of the neck flexor muscles can be further improved, than has been shown previously, by extension of the period of training with the specific low load neck exercise. Subjects: Nine individuals with idiopathic neck pain has been included. Measures: Myoelectric activity of the deep and superficial neck flexor muscles have been recorded using surface electromyography (EMG). The onset of activity of the neck muscles in a quick arm movement task has been assessed as the primary outcome measure. Procedures: EMG measures have been assessed at baseline before starting 3-month exercise training and then every 4 weeks up to 4 months. Participants have been taught a low load home exercise that is designed to gently and precisely activate the deep neck flexor muscles. The exercise training involves a low intensity upper cervical flexion motion (i.e. similar to a chin nod) in lying twice a day and correcting posture twice per hour. For progression of the exercise the number of repetitions and the target load has been increased as the patients were able. The accuracy of the home exercise has been checked every week by a specialist physiotherapist.

Vitamin B12 is essential for cells in the body to function and regenerate themselves properly. Deficiency in this vitamin causes damage to the genetic material (DNA), anaemia, nervous system malfunction, loss of mental capacity and dementia. Older persons have a reduced ability to absorb and utilise vitamin B12 efficiently and are therefore at greater risk of vitamin B12 deficiency. Cow’s milk is an important source of vitamin B12. The whey fraction of milk contains highest amount of vitamin B12. This study will test whether consumption of whey protein isolated from cow’s milk: increases vitamin B12 levels in blood, reduces DNA damage and improves memory and other mental functions. If this hypothesis is proven, whey protein isolate could be recommended as a part of a dietary pattern designed to increase vitamin B12 levels in older persons.

Injuries to the neck following whiplash trauma (whiplash injury) are one of the most common causes of neck pain and disability in the developed world. The purpose of this study is to investigate the use of magnetic resonance (MR) imaging in combination with physical and psychological measures, to identify structural lesions of the neck following whiplash injury. The ability to identify and differentiate the relationship between structural lesions and physical and psychosocial measures in whiplash patients will potentially enable more specific and timely management thereby potentially reducing the number of patients who develop chronic symptoms.

This study will evaluate whether the addition of a survivorship care plan to standard follow-up care is feasible and whether it will have an impact on quality of life and unmet needs in survivors of early breast cancer. Who is it for? Participants in this study are women aged 18 years and above who have completed hospital-based treatment for early invasive breast cancer (surgery, radiotherapy and/or chemotherapy). Study details All participants in this study receive a survivorship care plan in addition to standard follow-up care. The survivorship care plan is a written summary of cancer treatment with a follow-up plan for future care. The care plan will be developed by one of the patient's regular cancer specialists, in consultation with the woman herself. A schedule for follow-up consultations and tests will be developed. The woman will also be advised about what to expect (health and emotions) in the months and years to follow, and who to contact if there are problems between visits. Participants will complete baseline questionnaires evaluating their unmet needs and quality of life. They will then receive routine cancer follow-up, supplemented by the survivorship care plan for a period of 18 months. Questionnaires will be repeated at 6 and 18 months from enrolment in the study. The 6 and 18 months questionnaires will also include an evaluation of the care plan.

Iron deficiency is commonly seen in congestive heart failure (CHF) in both anaemic and nonanaemic patients. Recent studies have shown that intravenous iron treatment for iron deficiency, with or without anaemia, in congestive heart failure patient improves symptoms, functional capacity and quality of life. This study expand the investigation on the effect of intravenous iron to exercise capacity, echocardiogram changes as well as physical functioning and quality of life in patients with iron deficiency and congestive heart failure.

This is a multi-center, prospective, study to collect data on the commercially available Nevro Senza SCS System. Outcomes will be assessed via standardized assessments (trial and IPG implant procedures are part of routine practice). The purpose of this study is to document and assess safety and effectiveness of HF10 electrical stimulation delivered to the spinal cord in subjects with chronic, intractable pain of the upper limb and neck, as part of the centers’ routine practice (on-label use of TGA approved/CE marked device). Data at follow-up visits will be compared to Baseline data collected at the beginning of the study. This study includes extensive data collection (Trial and IPG implant procedures are part of routine practice). Subjects will participate in this investigational plan that includes entry criteria evaluation, baseline assessments, trial stimulation phase, and post-trial assessment. Subjects with a successful Trial Phase will be implanted a permanent system (i.e. IPG) and leads as per center’s routine practice, and undergo 12 months of stimulation delivery with assessments at 1, 3, 6, 9, and 12 months Post-Permanent Device Activation. Assessments of pain and adverse events will be made at 1 month and 9 months following Post-Permanent Device Activation. At 3, 6, and 12 months Post-Permanent Device Activation, subjects will be assessed for pain and adverse events as well as disability, functioning, neurological assessment, medication use, quality of life, depression and sleep. Patient Global Impression of Change, Clinician Global Impression of Change and subject satisfaction will be recorded at 3 and 12 months Post-Permanent Device Activation.

BACKGROUND A significant proportion of caregivers of palliative care patients experience severe psychological distress and complicated grief. Little is known on the psychological impact of a patient’s death and dying among significant others who may not be recognised as the primary caregiver but nonetheless share a close relationship. However, research has shown that caregivers and significant others indicate a similar need for support. In this project, we will evaluate an Acceptance and Commitment Therapy based intervention for caregivers and significant others. Acceptance and Commitment Therapy (ACT) is a mindfulness-based behavioural therapy that encourages individuals to accept unwanted private experiences (e.g. thoughts, feelings) that are out of their personal control and engage in values-guided action that gives meaning to their lives. The intervention is a guided self-help program consisting of an ACT booklet and telephone support by a counsellor. AIMS To measure the efficacy of the ACT self-help program at postintervention in improving: 1. acceptance and valued-living 2. depression and grief METHODS This project is a two-arm randomised controlled trial: participants are randomly allocated to the intervention or control group. The control group will receive treatment as usual from the palliative care service in the form of psychosocial support from social workers. The intervention group will receive the ACT booklet and telephone support. The booklet will guide caregivers and significant others to manage difficult thoughts and feelings and engage in valued activities (i.e. things they care about that give them meaning and fulfilment). The telephone support comprises a phone call after 1 week of receiving the booklet to address questions about the self-help booklet. Participants complete three questionnaires: preintervention, 1-month postintervention, and 6 months postbereavement. The questionnaires ask about feelings; values in life; attitudes towards life, death and dying; and communication with the patient.