ANZCTR search results

This is a Multicentre, prospective, randomised, placebo-controlled, double-blind, parallel group phase III trial with an adaptive sample size re-estimation in stroke survivors enrolled 3 or more months after their event. The primary objective is to test the hypothesis that in stroke survivors, 200mg of modafinil taken once daily for at least 56 days significantly improves participant quality of life compared to placebo, due to the improvement of severe and persisting fatigue after stroke. The trial will screen potential participants with the Multidimensional Fatigue Inventory (MFI) score of above 60. Upon consent and if patient meets other specified inclusion and exclusion criteria they will be randomised to either modafinil (200mg) or placebo once daily for 56 days. The main study visits include screening, Day 0, Day 28 and Day 56 for trial assessments with the SF-36, TMTs, FSS, MoCA, DASS 42 and the EQ5D and mRS. Caregivers will also be compete CSI and OCBS at each study visit The study sample size has been calculated to be 300 recruited participants (150 in each arm). There are three optional sub-studies. 1. Open-Label modafinil for an additional 10 months and return to the study centre for trial assessments after the 10-month treatment phase. 2. Physical activity monitoring and 3. Cognitive assessments

A major gap exists in Australia, and internationally, for providing care to support and maintain functional and social independence of older people with dementia at home. The pilot study of the Interdisciplinary Home-bAsed Reablement Program (I-HARP) points to the benefit of an interdisciplinary team as having the maximum impact. The proposed project will implement and evaluate this novel bio-behavioural-environmental I-HARP model, into existing health and aged care services. I-HARP is a time limited bundle program, consisting of: 1) 12 x home visits, tailored to the individual client’s needs (carried out by occupational therapist, registered nurse, and other allied health staff); 2) minor home modifications and/or assistive devices to the value of up to $1000 per participant; and 3) three individual carer support sessions, at the beginning, middle and end of the series of home visits. The aim of the study is to determine the effectiveness of I-HARP on functional independence, mobility, quality of life and depression among people with dementia, their home environmental safety, carer burden and quality of life, and I-HARP cost-effectiveness. Participants will be older people with mild to moderate dementia, who receive care from participating aged home care services and hospital geriatric services, and their carers. Following informed consent and baseline assessment, eligible participants will be randomly allocated into either the intervention (I-HARP) or the control group (standard care). The study will test the following hypotheses: At 20 weeks, compared to the usual care group, the I-HARP group will have • improved functional independence (primary outcome); • enhanced quality of life; • improved mobility; • reduction in depressive symptoms; • improved carer quality of life; • decreased carer burden; and • improved home environment safety. At 52 weeks, compared to the usual care group, the I-HARP group will have • sustained the benefits of the intervention (1-7 above); and • had decreased total health care costs. I-HARP addresses one of the most costly, often overlooked and significantly undertreated aspects of old age, particularly among people with dementia: the ability to carry out everyday self-care activities and maintain independence. The proposed trial will confirm I-HARP’s scalability in community aged care services operating under Commonwealth supported home case service, and hospital based geriatric services, both of which are designed to support frail community dwelling older people to maximise their independence in their home environment.

The primary aim of this study is to pilot test the feasibility of a randomised trial that compares the effectiveness of new generation securement and dressing products for intra-arterial catheters (IAC). The RCT aims to (i) identify clinical, cost-effective methods to prevent catheter failure due to infection, inflammation, occlusion, infiltration/extravasation, dislodgement and/or poor trace; (ii) compare usual care dressings with two novel methods; (iii) evaluate the acceptability of these devices to patients and health professionals; and (iv) study adverse effect profiles. You or your child may be eligible to participate in this trial if you are an intensive care patient under the age of 18 and are having an intra-arterial catheter inserted as part of your required therapy (which is expected to remain in place for at least 24 hours). All participants enrolled in this trial will be randomly allocated (by chance) to receive one of three IAC securement options. This will be either the standard bordered polyurethane dressing; medical grade superglue, or an integrated securement device. The allocated dressing will be applied from device insertion until the time of device removal. Participants and families will be asked to rate the acceptability of the device and dressing, and the device will be observed closely to examine side effects, and device failures. It is hoped that the findings of this trial will provide information on which IAC securements are most effective in preventing IAC failure among paediatric patients.

The purpose of this study is to evaluate the efficacy of pelvic drain versus no pelvic drain on lymphocele rate in men undergoing robot-assisted radical prostatectomy for prostate cancer. Who is it for? You may be eligible for this study if you are aged 18 years or above and are undergoing robot-assisted radical prostatectomy for prostate cancer. Study details The study will compare the placement of pelvic drain versus no pelvic drain after robot-assisted radical prostatectomy (RARP). Patients will be allocated to one of two treatments based on chance alone. The intervention (drain or no drain) will be implemented at the end of the RARP operation. The urological surgeon will be responsible for the safe placement of drain (or no drain). The drain is made of plastic and is placed in the pelvis adjacent to the surgical bed. Duration of placement typically ranges from 12 to 36 hours. It is hoped that this study will provide high quality evidence to inform management for Australian and international urologists.

The purpose of this research study is to implement and evaluate a toxicity-targeted intervention during treatment for cancer. Who is it for? You may be eligible to join this study if you aged 18 years or more and are a cancer patient undergoing any cancer treatment. Study details Participants in this study will be randomly allocated (by chance) to either 12-weeks of an exercise intervention or usual care. Participants in the exercise intervention group complete cardiorespiratory/aerobic, resistance, balance and stretching exercises on 3 days of the week; which are individually tailored to each intervention participant. Participants in both groups are required to undertake assessments both before, during and after the 12-week intervention period. These assessments are related to cancer-related fatigue, neurotoxicity development, cardiovascular disease risk development and other health measures (e.g. body composition, blood markers, overall body strength, cardiorespiratory fitness). Some participants will also be invited to attend a focus group discussion on the quality and feasibility of the intervention after intervention completion.

This study is aimed at patients with Type 2 diabetes diagnosed with fluid retention in the back of the eye called "diabetic macular oedema" (DME), a main cause of vision impairment in diabetic eye disease. Standard treatments include anti-vascular endothelial growth factor injections or laser therapy to the affected eye. These are invasive, costly and carry significant risks including risk of blindness. This study will investigate whether fenofibrate (an oral agent shown to slow progression of diabetic retinopathy) reduces DME and thereby reduce the standard treatment interventions required. Cost-effectiveness for standard treatment versus standard treatment with fenofibrate will be compared.

This study aims to examine efficacy of pelvic floor muscle exercises compared to standard care to improve bowel function following ileostomy/colostomy reversal following a diagnosis of rectal cancer. Who is it for? You may be eligible for this study if you are aged 18 or older, have had/have rectal cancer and have a temporary ileostomy or colostomy planned for a reversal procedure. Study details Participants will be randomly assigned (by chance) to either continue standard care or continue standard care in addition to pelvic floor muscle exercises. Participants in the exercises group will perform the exercises daily as instructed by the physiotherapist after initial assessment 6 weeks prior to reversal of stoma. Following stoma reversal participants randomised to PFME will be assessed by a physiotherapist again at 2 weeks , 3 months and 6 months. All participants , including those randomised to standard of care, will complete patient diary and quality of life assessments at 2 weeks, 3 months and 6 months after stoma reversal. It is hoped this research will contribute to improved quality of life in patients after their reversal surgery.

The aim of this study is to determine change in opiate dose in patients referred to NQPPMS after RADAR compared to individual pharmacist support or usual medical care. The secondary objective of this study is to assess whether a reduction in opioids is associated with improvements in quality of life using the EQ5D5L and we will conduct interviews with participants to obtain their perception of reducing opioids. Groups will be based on patient selfselection. Group 1; RADAR Group 2; individual telephone support from the pharmacist Group 3; those who do not wish to participate in either group or individual support; will receive normal medical care via GP. We will collect outcome measures at 3 months, 6 months and 1 year. We hope to study between 6 to 10 patients in each RADAR group and will match these with patients receiving individual pharmacist or GP support Based on our experience, we hope that patients attending the group will be more successful than those with GP care and that outcomes will be the same or better than pharmacist support.

This project aims to evaluate an online face-to-face communication training program (HEARhelp Online) for adults with hearing loss an their communication partners. HEARhelp Online is a simple, web-based intervention that addresses the need to make people more aware to speak to someone with hearing loss face-to-face. It is specifically tailored dyads comprising of an adult with hearing loss and a frequent communication partner and aims to improve face-to-face communication around the home. Participants will include a maximum of 517 dyads, who will be randomised to either the intervention group (HEARhelp Online + treatment as usual) or the control group (treatment as usual). Dyads in the intervention group will complete 5 online modules (which include information, videos and activities) over a 5 week period. It is hypothesised that participating in the HEARhelp Online training program (+ treatment as usual) will: (1) lead to significantly greater decrease in hearing disability experienced by adults with hearing loss and their communication partners, compared to the control group (treatment as usual), (2) Be more cost-effective, compared to control group (treatment as usual), (3) be associated with positive changes in capability, opportunity and motivation, and (4) be associated with positive changes in use of face-to-face communication training. Participants will be asked to complete surveys at baseline, week 7 (immediately post-intervention) and 4.5 months (3 months post-intervention). Participants may also be invited to participate in an interview at 4.5 months (3 months post-intervention). Data will be analysed using descriptive statistics, mixed effects models, a series of two-way mixed ANOVAs and qualitative interviews.

The study is a single-center, double-blind, dose-escalation, single-dose design to assess safety and tolerance of M8 and to identify a dose range for phase II study and to determine the maximum tolerated dose (MTD) of M8. M8 is expected to be indicated for the treatment of unstable angina pectoris of coronary heart disease (CHD), carotid atherosclerosis, and ischemic stroke sequelae. Forty (40) healthy subjects will be randomized with 5 dose level, 8 subjects per dose level (cohort). Eligible subjects will be sequentially enrolled into 5 dosing cohorts (2.4g (6 capsules), 4.8g (12 capsules), 7.2g (18 capsules), 9.6g (24 capsules), 12g (30 capsules), orally, single dose). The study will start with the lowest dose level given to the first cohort of eight subjects. Eligible subjects will be admitted to the unit on Day -1 and conduct all qualification assessments. Subjects will be allowed to leave the unit after all the 48 h assessments have been completed on Day 3 and will return for follow-up assessments on Day 5. After satisfactory review of the available safety and toleration data, the next dose level will be processed if the previous dose was well tolerated. If the previous dose was not well tolerated, after reviewing the safety data, and discussions between the Investigators, Medical Monitors from CRO and Sponsor, the same dose level may be repeated. If this dose level is well tolerated, the study will continue to the next higher dose. If this dose level is not well tolerated again, the MTD is defined at the prior lower dose level and the dose escalation will be stopped. Descriptive statistics will be performed for safety data (AE/SAE, 12-lead ECG, physical examinations, vital signs, and laboratory tests). The current version of the MedDRA will be used to code all AEs. Update Brief summary