ANZCTR search results

The primary objective is to investigate the effects of peanut butter (43g/d), consumed for 6 months, on 1) older adults’ functional capacity (primary outcomes) and its associated factors such as cognitive function, lean mass, muscle strength, as well as late-life function and disability, which reflects real-world endpoint related to physical capacity. The secondary objective is to explore if the effects of peanut butter supplementation on primary objective outcomes are mediated by improvement in diet quality following peanut butter supplementation.

Premature babies (born before 8 months of pregnancy) are at risk necrotising enterocolitis (NEC), a potentially serious inflammatory condition of the bowel, as well as hospital acquired infections, and poor nutrition. Complications of prematurity such as these, especially NEC, increase the risk of death, and long-term disability. The risk of these complication is high especially in extremely premature babies born before 28 weeks of pregnancy. Probiotics are beneficial bacteria which have been shown to significantly reduce the risk of death, NEC, and hospital acquired infections whilst facilitating nutrition in very premature babies. Probiotic supplementation for very premature babies is a standard practice in all neonatal intensive care units (NICU) in Australia, New Zealand and many units in other countries. We currently administer a daily dose of 3 billion probiotic bacteria for premature babies in our unit using a product imported from Japan, under a special permission from the Australian government. This dose is based on our research using this product and studies of other probiotics. This study is designed to assess if a dose higher than 3 billion bacteria per day is more effective whilst being safe in reducing inflammation and improving the balance of beneficial versus potentially harmful bacteria in the gut of extremely premature babies. Specifically, the proposed study will compare the dose of 3 billion against 6 and 9 billion bacteria per day in extremely premature babies using the stool (poo) samples. We think that babies who receive higher dose of probiotics will have reduced gut inflammation, more beneficial and less harmful bacteria in the gut and overall health compared to those who receive lower dose.

Depression is highly prevalent and associated with increased hospitalisation and mortality among patients with heart disease. A whole-person care approach to depression management, encompassing mental wellbeing, behavioural risk factors and treatment adherence, is needed. This study will test whether a wellbeing program for patients discharged with Acute Decompensated Heart Failure (ADHF) improves emotional and physical wellbeing. A two-arm RCT with participants randomly allocated to intervention (an enhanced community care program for heart failure: “Enhanced HF Care”) or usual care. Eligible patients with ADHF will be recruited prior to discharge from two hospitals. Patients will be provided access to Enhanced HF Care, and via the program, will be prompted to monitor depression and clinical outcomes. Guideline adherent actions for clinically significant depression scores and clinical outcomes will be utilised. Automated parameters within Enhanced HF Care will trigger specific action advice for patients, such as self-care recommendations (via videos or written information). Cardiac nurse specialists will track real-time patient data from a dashboard, and receive automated emails when patients provide high-risk data. Cardiac nurses will prompt cardiologists to action, where needed. General practitioners will receive automated emails for patients reporting high levels of depression and encouraged to schedule a patient consultation. Outcomes will be assessed at one and six-months via brief measures for Quality of Life. Intervention participants will also complete brief weekly/fortnightly measures for depression via the program. Healthcare utilization will be examined via patient self-report and hospital admission data. The primary analysis population will be the intention to treat, defined as all randomised participants. The co-primary outcome variables will be compared between treatment arms using separate linear mixed effects regression models. This study has the potential to reduce the burden of depression for patients following ADHF. This novel process will prioritise urgent patient mental health needs while empowering the patient with self-care knowledge.

This study aims to determine whether the use of a herbal treatment (Annona muricata leaf product) is safe and tolerable for use in people with stage III and IV cancers of any type, who are not undergoing chemotherapy treatment. Who is it for? You may be eligible for this study if you are aged 18 or older, you have been diagnosed with any cancer type that is at stage III or stage IV, and you are not currently undergoing chemotherapy. Study details Participants who choose to enrol in this phase I study will be allocated to one of two doses of Annona muricata leaf product, and will be asked to take either one or two capsules daily for 12 weeks. At the time of enrolment, 3, 6, 9 and 12 weeks after their first dose, participants will be asked to provide a blood sample and to complete a series of questionnaires. It is anticipated that these tasks will take up to 30 minutes to complete, participants will be able to complete the questionnaire from home if they prefer. It is hoped this research will inform the clinical management and guidance provided by clinicians involved in the care of people who choose to use Annona muricata leaf product in the overall management of their cancer. If this product is found to be safe and tolerable, it may be prescribed to future cancer patients as an additional treatment.

We will recruit pregnant women with a prior history of gestational diabetes mellitus (GDM) as part of a randomised control trial (RCT) to undertake the healthy gut dietary intervention (or control). We hypothesise that women who are provided dietitian counselling and education about a Healthy Gut Diet will improve their gut health (measured as the gut microbiome) and be less likely to develop GDM. The primary outcome will the proportion of women developing GDM. Other outcomes include changes to gut microbiota, diet quality, gestational weight gain, and maternal and infant outcomes. The study sites are Redcliffe and Caboolture Hospitals.

This study aims to investigate the feasibility of individualized exercise rehabilitation programs for people with persistent low back pain. A physiotherapist will collaboratively develop physical activity goals with participants. Based on these goals, an individualized exercise rehabilitation program will be developed in collaboration with participants based on their preferences, symptoms, abilities and assessment findings. This will include aerobic, strengthening and specific muscle activation exercises. The physiotherapist will also educate on ways to help participants’ pain. To monitor progress, participants will meet with the physiotherapist once weekly during the first month, once fortnightly during the second month and on one occasion only in the final month. In these sessions, the exercise rehabilitation program will be reviewed and may be progressed/modified to meet participants individual needs and exercise goals. Outcomes include abdominal and back muscle activation, pain, disability, satisfaction with the exercise program and feasibility considering recruitment rates, attrition and exercise participation. It is hypothesised that the individualised exercise rehabilitation group will have greater participation in their exercise program compared to the standardised exercise rehabilitation group.

Prehabilitation prior to stem cell transplant surgery for patients with multiple myeloma may enhance their recovery after the transplant, but delivery of these sessions in person may not be achievable for a variety of reasons. This study aims to modify an existing telehealth exercise platform (REMOTE-CR) to ensure that it is useful for patients with multiple myeloma. The revised platform will then be tested in a new exercise app (EXERT) to determine whether it is feasible for prehabilitation to be delivered via telehealth in this manner. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have a primary diagnosis of multiple myeloma, you are scheduled to receive a stem cell transplant, and you can understand and write English. Study details All participants who choose to enrol in this study will be given instructions on how to download and use the EXERT app to complete their prehabilitation program. After enrolment, all participants will be reviewed by a physiotherapist to determine their current fitness and fatigue levels. The physiotherapist will then design an exercise program for each participant based on their requirements and this program will be delivered through the EXERT app over a 6 week period. Over the study period participants will be asked to wear a sensor (similar to a Fitbit) that will record their heart rate, distance and speed of exercises performed. These details will be reviewed by the study clinicians who can then tailor the exercise program for participants to ensure that they aren't over-or under-exerting themselves. It is hoped that the EXERT app will be well received by those who are unable to attend face –to-face oncology rehabilitation at Barwon Health, and that this method of prehabilitation delivery will be shown to be feasible and acceptable.

Behavioural and psychological symptoms of dementia (BPSD) can be extremely stressful for the individual, carers and staff and are a contributing factor for people admitted to Residential Aged Care Facilities (RACFs). This research will involve a RCT across multiple sites aimed at assessing the effectiveness and implementation of a clinical pathway (‘the pathway’) to reduce antipsychotic treatment and adverse events. This study aims to determine the effectiveness of the pathway for best-practice management of BPSD. A secondary aim is to better understand the feasibility of implementing the pathway in multiple RACFs. Research questions: • Does the pathway improve clinical outcomes for individuals with BPSD in RACFs? • What are the barriers and facilitators of successful implementation of the pathway across RACFs? This study will provide evidence to improve quality of care and quality of life for people living with dementia in RACFs. The primary hypothesis is that the number of antipsychotic prescriptions specific to BPSD will be lower for the RACFs that implement the pathway compared to control RACFs. Secondary hypotheses are: (1) the quality of life of participants will be higher for the sites that implement the pathway compared to controls; and (2) the incidence of adverse events, call outs for Dementia Support Australia/specialist referral, and hospitalisations will be lower for the sites that implement the pathway than controls. A process-evaluation will collect exploratory data on the implementation of the pathway in multiple sites.

The primary aim is to establish baseline and change quality of life (QoL) levels for up to one year in older adults who present to Eastern Health with a fragility hip fracture (HF). Secondary aims are: 1) to validate ACS NSQIP risk calculator in older Australians after hip fracture surgery; 2) assess the correlation of MMSE score to post-operative outcomes and HRQoL 3) evaluate the relevance of intraoperative/postoperative data relating to renal function, intraoperative hypotension, and postoperative S. troponin This study will be a prospective observational cohort study. Patients will be identified after presenting with a hip fracture and be assessed for eligibility by one of the team members. Patient recruitment will occur at Box Hill Hospital or Maroondah Hospital, depending on where the patient presents or is transferred to at the time of review. Eligibility criteria includes patients aged 65 years or older who present to Eastern Health for low-trauma hip fracture, including both operative and non-operative patients. Potential participants will be evaluated within 72 hours after admission and prior to surgery. The exclusion criteria include high-energy trauma, pathological fracture, patients receiving palliative care, a history of previous hip fracture on the same side, periprosthetic fractures, patients having not decided on participation prior to surgery or after 72 hours from the time of admission, patients and proxy respondents being unable or unwilling to give valid consent, including visual, hearing, mental incompetence and non- English speaking patients or proxy respondents. Patients who die or sustain a second fracture during the follow-up period will also need to be excluded from HRQoL and functional capacity analysis. Quality of life will be assessed using the EQ-5D-5L questionnaire. Functional capacity will be evaluated using the Barthel Index. Preinjury HRQoL and disability will be assessed at time of recruitment. Participants will then be followed up at 4 and 12 months by telephone.

Taurolidine-citrate solution has been used effectively as a catheter-lock device to reduce infection and blockage in central venous catheters and tunnelled peritoneal catheters and has been used intra-pleurally. This study aims to assess the safety of Taurolidine-citrate (TauroLock) in indwelling pleural catheters (IPCs).