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Efficacy of a health literacy intervention to improve cardiac services for patients with coronary heart disease
The aim of this study is to determine whether a co-designed health literacy intervention can improve health literacy among inpatients admitted with their first presentation of acute coronary syndrome. Sixty participants will be randomised into either the intervention or control group. The intervention group will be provided with the Patient Discharge Action Plan in addition to usual discharge education. The control group will receive usual discharge education. Information about participants’ health literacy and other factors will be collected through self-report or medical records at baseline, 2-weeks and 3-months after discharge. Interviews will be also be offered at 3-months. Expected outcomes are that the intervention group will have a greater improvement in health literacy, lower anxiety and depression, emergency department presentations and higher attendance at cardiac rehabilitation compared to the control group at follow-up time-points.
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Clinical Emotional Freedom Technique for Vision Impairment and Psychological Issues: A randomised online trial
Vision impairment (VI) is considered to be a serious public health issue, affecting more than 4 million people aged at least 40 years in the United States and at least 2.2 billion people worldwide. It is also estimated that over 13 million Australians have one or more chronic (long-term) eye conditions or VI, according to self-reported data from the Australian Bureau of Statistics (ABS). VI has a profound effect on overall levels of health related quality of life (HRQOL) in the individuals who suffer from it, and a significant association between VI and psychological issues such as anxiety and depression has been found. Although there is quite a robust association found in the literature regarding VI and the development of depression, anxiety remains an understudied topic as an associated psychological aspect of VI. Some studies have found that there is indeed a positive association between the incidence of VI and the development of anxiety, however other studies do not find a relationship. The aim of this study is to offer participants an 8-week self-directed psychological intervention program, which may impact psychological concerns such as anxiety and depression. An initial 2006 (unpublished) 8-week trial of Emotional Freedom Techniques (EFT) for eyesight conditions and anxiety found in a sample of 120 adult volunteers, there was a significant difference between men and women in terms of overall eyesight improvement (p=.022; Look, 2006). This research will also explore the psychological issues associated with VI in adults.
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Amnion cell derivatives for fistulising perianal Crohn’s disease
Complex perianal Crohn's fistulas are common with poor healing rates and high relapse rates despite long-term immune medications and repeated surgical procedures. Local fistula injection of stem cells derived from fat tissue is a new effective treatment.. We have completed a Phase I study using local injection of amniotic epithelial cells from the placenta in 10 adults with refractory complex Crohn's and reported the treatment as safe, well-tolerated and there was fistula improvement in 8 of 10 patients. In this study, we are using stem cell products produced from the amniotic cells instead as they also have medicinal properties. Participants will receive one or two injections of stem cell products into the fistula during examination under anaesthesia and undergo assessment using routine colonoscopy, blood tests, stool tests and MRI scans. We hypothesise that these stem cell products will be safe, well-tolerated and feasible to inject.
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Efficacy of scalable approaches to reducing alcohol and other drug use among traumatised young people
This study seeks to examine the efficacy of integrated psychological therapy for co-occurring traumatic stress and substance use among adolescents and young adults aged 12-25 years, delivered in person and via telehealth (i.e., video conferencing). Through this trial we hope to improve our understanding of how best to treat young people experiencing traumatic stress, who are also using alcohol or other drugs, and provide evidence for interventions with maximum reach and accessibility. Eligible participants will be randomly allocated to receive one of two treatments: i) Concurrent Treatment with Prolonged Exposure – Adolescent (COPE-A) delivered via telehealth; or ii) Concurrent Treatment with Prolonged Exposure – Adolescent (COPE-A) delivered in person. Both treatments consist of up to 16, one-on-one, sessions with a psychologist. Participants will also be asked to complete three research interviews at baseline (i.e., study entry), 4- and 12-months post baseline. The primary outcome is change in PTSD symptom severity. It is expected that pre- to post-treatment reductions in PTSD symptom severity in participants receiving COPE-A via telehealth will be non-inferior to reductions observed among participants receiving COPE-A in person. A range of secondary outcomes will also be examined including changes in substance use, emotional functioning and health-related quality of life.
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A First-in-human Study of APG990 in Healthy Participants
The main aim of the study is to evaluate the safety and tolerability of single doses of APG990 in healthy participants. The results of this study will help inform the dosing and frequency of dosing in patients with inflammatory diseases such as atopic dermatitis, which is the anticipated main therapeutic use for APG990.
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Investigating Adherence to an Online Qigong Program for Older Adults Living Within the Community.
Based on the findings of a previous research findings (RMIT Ethics Ref: 24895), we noted that a digitally delivered Qigong program for older adults, the Qigong Plus Program, was both feasible and acceptable amongst pilot study participants. Therefore, this follow-up project will build upon previous findings and deliver an enhanced Qigong program for older adults that employs additional behaviour change interventions strategies to sustain participant engagement, both during the program and subsequently promoting long-term Qigong practice. The use of pre-recorded sessions allows the participant freedom to decide the timing for their program delivery, resulting in a heightened sense of perceived self-agency towards their health.
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Evaluation of the Endometriosis at Work program
This project intends to implement the co-designed endometriosis guidelines into an Australian workplace, and seeks to understand if and how the education, supports and accommodations offered within the guidelines enable people with endometriosis to manage their pain while working; understand the impact of the guidelines on work and wellbeing outcomes for those with endometriosis; explore ways in which the guidelines impact workplace culture and support; and to refine and provide recommendations to finalise a set of national employer guidelines to support employees to manage endometriosis and to assist their supervisors to do so. It is hypothesised that after 12 months of the endometriosis guidelines being implemented, that employees with a diagnosis with endometriosis will have improved health-related quality of life, improved work outcomes (presenteeism, absenteeism, and retention). Additionally it is hypothesised there will be an improved perceived level of managerial support and improved workplace culture as perceived by the staff at the targeted workplace.
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A pilot study to evaluate the effectiveness of intranasal Botulinum Toxin Type A Spray for patients with Rhinitis
Rhinitis affects approximately 20 to 40% of the population and is currently poorly controlled in approximately 15% of the population with standard treatment. Botulinum toxin type A spray could provide a painless, easily applied and potentially alternate treatment for sufferers. Currently there is wide use in cosmetic clinics but few supporting clinical trials. . HYPOTHESIS We aim to test the hypothesis that botulinum toxin type A is an effective treatment for rhinitis when delivered via intranasal spray, as measured by total nasal symptom score. INTERVENTION 40 units Botulinum toxin type A administered topically intranasally using the LMA® MAD Nasal™ Intranasal Mucosal Atomization Device by Teleflex (ARTG number 294634). 20 units will be administered per nostril at the base line visit of the study.
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Impact of an online fibre education intervention on fibre consumption in young adults: A randomised controlled trial pilot
The theory of planned behaviour is based on the premise that individuals will formulate plans of action based on the information and knowledge available to them. The study uses this theory to investigate whether the delivery of a one-month educational information package to young adults via email and text message will increase dietary fibre consumption. Dietary surveys delivered before and after the intervention will measure any alterations in dietary behaviour. Surveys relating to mood will evaluate any impacts of fibre intake on anxiety and depression. We hypothesise that increasing awareness of the benefits of dietary fibre consumption via education will lead to improved dietary behaviours.
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Survival and Patterns of Care in the Era of Chemo-, Radio-, and Immuno-Oncology for Gastroesophageal Junction Cancers
This study aims to address the lack of information on the efficacy and safety of surgery in combination with chemotherapy (FLOT) alone OR chemotherapy, radiotherapy and immunotherapy (CROSS/nivolumab) in treating cancers involving the lower oesophagus and the junction of the oesophagus and stomach (GOJ cancers). This lack of information may lead to significant variations in practice as clinicians lack the evidence to help decide which treatment is best for their patients. This has led to unnecessary harm and even deaths due to potentially avoidable treatment complications and early cancer recurrence. Who is it for? You may be eligible for this study if you are aged 18 years and over, with adenocarcinoma involving the lower oesophagus and GOJ who underwent surgical resection. Received either neoadjuvant CROSS chemoradiation + adjuvant nivolumab OR perioperative FLOT chemotherapy between 1st January 2017 to 31st December 2023. Study details For all participants, information regarding survival and disease progression (identified clinically, biochemically, and/or radiologically) will be obtained from your electronic medical record, with no study visits or additional testing required. This data will be used to compare the survival and disease progression between different treatments. It is hoped that this research will determine how immune cells within these cancers respond to the different treatments, which will serve to inform clinicians of the optimal, personalised treatment for their patient that derives maximal benefit whilst reducing harm.