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There is a great deal of lay information to suggest that people with MS or at risk of MS should take oral Vitamin D supplementation. However, no adequately powered scientific study has examined the role of Vitamin D3 supplementation as prevention or treatment for MS. There is insufficient commercial interest in conducting such a study, but the need for evidence is great. If effective, oral Vitamin D supplementation could provide a low cost MS therapy with virtually no side effects. Sponsored by Multiple Sclerosis Research Australia, we therefore plan to conduct a randomised, placebo controlled, double-blind clinical trial to assess the efficacy of oral Vitamin D3 in preventing the development of Multiple Sclerosis in participants at high risk of MS (participants with a first demyelinating event, FDE). We will compare three doses of oral daily vitamin D3 (1,000IU 5,000IU or 10,000IU/day) to placebo. After agreeing to participate, participants will be randomly and blindly assigned to one of these four study arms and will continue to take study medication for 48 weeks. Scope: We plan to enrol 240 participants with FDE from 21 Australian and New Zealand MS trial centres over the course of three years. We may invite additional centres depending on recruitment and trial progress.

This study has been designed to test a depression risk assessment questionnaire. Patients who have been admitted to hospital for severe chest pain or a heart attack often get depressed once they have returned home. By asking patient certain questions about their past mental health and recent events we hope to predict which patients may be at risk of becoming depressed.

Patients undergoing elective hip or knee replacement experience different levels of pain and anxiety before and after their surgery. Providing education to patients on strategies to help them manage the pain and anxiety they experience could help improve patients’ physical and psychological outcomes after surgery. This study hopes to test whether education provided to patients before surgery can assist in their management of pain and anxiety while undergoing hip or knee replacement. Patients who agree to participate in this study, will be randomly assigned to either receive a DVD with self-efficacy information and activities to take home combined with the usual pre-operative education (the ‘self-efficacy education intervention group’ [A]) OR receive the usual pre-operative education and care (without the DVD) only (the ‘routine care group [B]). Participants who are allocated to receive the DVD are asked to view this and perform the activities (ie., relaxation, breathing and imagery exercises) within 72 hours and then on three other occasions until their booked surgery. A research assistant (registered nurse) will call the ‘self-efficacy education intervention group’ [A] participants on the telephone after 72 hours and then again before admission to support their participation. All participants will be assessed for levels of pain, anxiety, self-efficacy at the first three time points (T0-2). Participants will also be asked to respond to a survey about their satisfaction with care in relation to pain management on the day of their discharge/day 4 post-operatively (T3). Ten to fourteen days following discharge (T4), patients will be contacted via telephone at a suitable time to rate their pain, anxiety and self-efficacy as well as their utilisation of health services and resources. Finally 6 weeks after surgery (T5), patients will be telephoned at a suitable time to rate their pain, anxiety, utilisation of health services and resources and utilisation of relaxation method(s). Apart from the day of surgery, all other time points (T0, T2-5) will record the use and frequency of pain medications via direct patient feedback or from the end-of-bed medication sheets. The time taken to complete the assessments at 6 time points will be approximately 10 – 15 minutes. The assessments will be in paper form, and participants will be required to respond to a series of questions.

This study aims to seek whether longer treatment protocols than previously applied in research will result in longer-lasting and stronger improvements in pain relief in ME/CFS and FMS. The study also seeks to investigate whether pain reduction is associated with improvements in other chronic illness symptoms.

Non-specific neck pain is a major burden in industry in terms of lost productivity (reduced work performance, lost days) and personal suffering (pain, disability, reduction in quality of life and reduced job satisfaction). Non-specific neck pain is a particular threat to productivity at work due to its tendency for chronicity and its recurrence. With more than 50% of office workers experiencing neck pain at some stage of their working life, significant resources have been allocated to improve the individual’s ergonomic working environment aimed at primary prevention of this problem. Emerging evidence supports the effectiveness of ergonomic interventions in reducing absenteeism and improving productivity, but to date it has shown minimal impact in preventing or reducing neck pain in the workplace. In contrast, a workplace neck strengthening exercise protocol has demonstrated effectiveness for reducing the severity of neck pain in office workers but its impact on productivity has not been explored. Due to the recognised link between health and productivity, health initiatives at the workplace are gaining momentum. We propose that best practice ergonomic intervention combined with neck specific exercise is the optimal approach to minimise productivity losses and neck pain in the workplace. This project will test the impact of a workplace-based best practice combined ergonomic and exercise intervention on work productivity and severity of neck pain in a population of office personnel.

This study is examining the infectivity of a Plasmodium falciparum NF54 malaria cell bank in humans. Participants will receive a single inoculum of the malaria cell bank, which consists of human red blood cells containing P. falciparum NF54 malaria parasites. Following administration of the inoculum, we will measure the growth of the malaria parasites in the blood-stream and then administer anti-malarial treatment (Riamet) according to specific criteria (based on the number of parasites in the blood as well as clinical signs/symptoms of malaria). We will also be assessing the safety of the inoculum and also the way the immune system responds to it. Determining the infectivity and safety of the malaria cell bank is important as it will form a critical part of future clinical trials investigating the effectiveness of a new malaria vaccine that is currently being developed.

An open-label, 2-part, randomized, single-dose, crossover study to initially characterize the pharmacokinetics, safety, and tolerability of MK-0663B 90 mg/6 mg formulated as prototype tablets under fasted and fed conditions when compared to coadministration of the individual components. The change in pharmacokinetics for etoricoxib and tizanidine when administered under fasting (Part 1) and fed conditions (Part 2) will be characterized. MK0663B (combination treatment) is being developed for the treatment of acute pain in musculoskeletal conditions with swelling and muscle spasm. However, this study is in healthy volunteers only.

Currently few services aim to support people in the community who are experiencing mild cognitive difficulties or who have early dementia. However, the experience of cognitive difficulties and worry about the future can be very stressful for the person and their close family members; and may make everyday tasks, such as interacting in a group or managing finances, much more difficult. In this project we will develop and evaluate a new face-to-face psycho-educational and counselling program for people with cognitive difficulties and their close family members. The aim of the intervention is to help people implement practical strategies to manage cognitive difficulties in their day-to-day life. By increasing strategy use, we also hope to reduce the anxiety and depression that people with mild cognitive difficulties and their family members can experience. We will evaluate our counselling program by comparing the outcomes for people who undergo the program with those of a comparison group who receive service as usual (a randomised controlled trial).

High grade glioma (HGG) is a term used to encompass grade III anaplastic astrocytomas, oligodendrogliomas and glioblastoma multiforme. This is a rapidly terminal, progressive, and significantly debilitating group of diseases which robs patients of function, cognition, and personality, making this a highly distressing disease for patients, families and carers. In addition to the general cancer related caregiving issues, the impact of the disease on the patients’ ability to function leads to reduced quality of life, increased stress and carer burden for their caregiver . The diagnosis of a brain tumour is particularly stressful for carers because the prognosis is dire and life expectancy short. These carers report increased stress and distress levels and decreased quality of life compared to carers of patients with cancers with a good prognosis. There are more than 200 problems and burdens identified by caregivers, which fall under several categories including: physical health problems, social problems and information needs, emotional problems and burdens related to responsibilities and impact on daily life. Psychosocial interventions for caregivers in a range of situations have been developed with various aims including improving caregiver understanding and ability to care, self-efficacy, quality of life, stress reduction, and improving communication and relationships in the family. There is a paucity of information regarding the role or effect of interventions addressing the unmet needs of caregivers of patients with HGG. Thus far this group has carried out two investigations into the experience and needs of patients with HGG and their caregivers. The first was a qualitative study of the needs of patients with HGG and their caregivers. Caregivers described a time of rapid change and a steep learning curve where they struggled with caring for partners with major disabilities and not knowing where to seek additional support or assistance (Halkett et al. 2010; McConigley et al. 2010). The second was a quantitative study (SCGH HREC 2006-146) which examined the experiences of 100 patient-carer dyads at three time points during the disease trajectory: during combined chemoradiotherapy, and 3 and 6 months later. 31% of caregivers reported moderate distress (DT score 5-6) and 31% reported extreme distress (score 7-10). Caregivers also reported significantly more distress than patients (mean 5.1 vs. 4.1; paired t test p=0.01). Caregiver distress was associated with higher scores on the general health questionnaire (r=0.61, p<0.001). The top 5 moderate/high caregiver unmet needs were: 1. accessing prognostic information; 2. accessing financial support and government benefits; 3. accessible hospital parking; 4. impact of caring on usual life; and 5. reducing stress in the patients’ life. These preliminary results will be presented in a poster at COSA in November 2012. The development of our intervention is based on our preliminary data and the identification of several key components including the caregiver’s preparedness to care, sense of control, competence, self-efficacy, anxiety, depression and distress, social support, information, a sense of reward, meaningfulness, positive emotions, optimism, respite and relationship with the care-receiver. Our intervention is currently in the development phase and is aimed to cover all these areas. We are seeking support and advice regarding the development of the intervention from a variety of sources including medical oncologists, neurosurgeons, radiation oncologists, palliative care physicians, psychologists, social workers, nurses, experienced representatives from Carers WA and COGNO, as well as consumer representatives. The purpose of this project is to determine the feasibility and efficacy of this supportive-educational intervention for caregivers of patients with HGG.

High grade glioma (HGG) is a term used to encompass grade III anaplastic astrocytomas, oligodendrogliomas and glioblastoma multiforme. This is a rapidly terminal, progressive, and significantly debilitating group of diseases which robs patients of function, cognition, and personality, making this a highly distressing disease for patients, families and carers. In addition to the general cancer related caregiving issues, the impact of the disease on the patients’ ability to function leads to reduced quality of life, increased stress and carer burden for their caregiver . The diagnosis of a brain tumour is particularly stressful for carers because the prognosis is dire and life expectancy short. These carers report increased stress and distress levels and decreased quality of life compared to carers of patients with cancers with a good prognosis. There are more than 200 problems and burdens identified by caregivers, which fall under several categories including: physical health problems, social problems and information needs, emotional problems and burdens related to responsibilities and impact on daily life. Psychosocial interventions for caregivers in a range of situations have been developed with various aims including improving caregiver understanding and ability to care, self-efficacy, quality of life, stress reduction, and improving communication and relationships in the family. There is a paucity of information regarding the role or effect of interventions addressing the unmet needs of caregivers of patients with HGG. Thus far this group has carried out two investigations into the experience and needs of patients with HGG and their caregivers. The first was a qualitative study of the needs of patients with HGG and their caregivers. Caregivers described a time of rapid change and a steep learning curve where they struggled with caring for partners with major disabilities and not knowing where to seek additional support or assistance (Halkett et al. 2010; McConigley et al. 2010). The second was a quantitative study (SCGH HREC 2006-146) which examined the experiences of 100 patient-carer dyads at three time points during the disease trajectory: during combined chemoradiotherapy, and 3 and 6 months later. 31% of caregivers reported moderate distress (DT score 5-6) and 31% reported extreme distress (score 7-10). Caregivers also reported significantly more distress than patients (mean 5.1 vs. 4.1; paired t test p=0.01). Caregiver distress was associated with higher scores on the general health questionnaire (r=0.61, p<0.001). The top 5 moderate/high caregiver unmet needs were: 1. accessing prognostic information; 2. accessing financial support and government benefits; 3. accessible hospital parking; 4. impact of caring on usual life; and 5. reducing stress in the patients’ life. These preliminary results will be presented in a poster at COSA in November 2012. The development of our intervention is based on our preliminary data and the identification of several key components including the caregiver’s preparedness to care, sense of control, competence, self-efficacy, anxiety, depression and distress, social support, information, a sense of reward, meaningfulness, positive emotions, optimism, respite and relationship with the care-receiver. Our intervention is currently in the development phase and is aimed to cover all these areas. We are seeking support and advice regarding the development of the intervention from a variety of sources including medical oncologists, neurosurgeons, radiation oncologists, palliative care physicians, psychologists, social workers, nurses, experienced representatives from Carers WA and COGNO, as well as consumer representatives. The purpose of this project is to determine the feasibility and efficacy of this supportive-educational intervention for caregivers of patients with HGG.