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1.
Trials ; 23(1): 824, 2022 Sep 30.
Article in English | MEDLINE | ID: covidwho-2053955

ABSTRACT

BACKGROUND: This update summarises key changes made to the protocol since the publication of the original protocol for the NAVKIDS2 trial of patient navigators for children with chronic kidney disease (CKD) experiencing social disadvantage and provides the statistical analysis plan (SAP) which has not previously been published. METHODS/DESIGN: The original protocol was published in BMC Nephrology ( https://doi.org/10.1186/s12882-019-1325-y ) prior to the commencement of trial recruitment. During the course of the trial, some key methodological changes needed to be made including changes to eligibility criteria (addition of patients with CKD stages 1-2, broadening of financial status eligibility criterion, addition of patients living in rural/remote areas, modification of age eligibility to 0-16 years, addition of limits related to the language spoken by family, guidance regarding families with multiple eligible children), changes to sites, reduction of sample size, addition of virtual options for consent and study procedures in response to the COVID-19 pandemic, removal of staggered recruitment across sites, addition of outcomes, and changes to the timing and number of assessments. This update summarises the changes made and their rationale and provides the detailed plan for statistical analysis of the trial. These changes have been finalised prior to the completion of study follow-up and the commencement of data analysis. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618001152213 . Prospectively registered on 12 July 2018.


Subject(s)
COVID-19 , Patient Navigation , Renal Insufficiency, Chronic , Australia , Child , Humans , Multicenter Studies as Topic , Pandemics , Randomized Controlled Trials as Topic , Renal Insufficiency, Chronic/diagnosis , Renal Insufficiency, Chronic/therapy , SARS-CoV-2 , Treatment Outcome
2.
Aust N Z J Public Health ; 46(2): 170-176, 2022 Apr.
Article in English | MEDLINE | ID: covidwho-1583718

ABSTRACT

OBJECTIVE: Quantify change in wellbeing and health-related quality-of-life (HRQoL) in Aboriginal and Torres Strait Islander adults pre and post Australia's initial COVID-19 lockdown. METHODS: Aboriginal and Torres Strait Islander adults completed an online survey at Time 1 (October-November 2019; before the initial Australian COVID-19 outbreak) and Time 2 (August-September 2020; after the first Australian lockdown). We assessed wellbeing using a visual analogue scale (VAS) and HRQoL using the Assessment of Quality of Life (AQoL-4D) instrument. Participants who completed both surveys (n=42) were included to quantify change in outcomes over time and by comorbidity and demographic factors. RESULTS: Mean reduction in wellbeing over time was 6.4 points (95%CI -14.2 to 1.4) and was associated with age (18-54yo), financial instability and mental health comorbidity. Mean reduction in HRQoL over time was 0.06 (95%CI -0.12 to 0.01) and was associated with financial instability, high physical comorbidity level and mental health comorbidity. CONCLUSIONS: Aboriginal and Torres Strait Islanders aged 18-54yo, who were financially unstable or had elevated comorbidity during COVID lockdowns experienced greater reductions in wellbeing and HRQoL. IMPLICATIONS FOR PUBLIC HEALTH: As the COVID-19 pandemic continues in Australia, both urgent and forward planning is needed, especially for the priority groups identified.


Subject(s)
COVID-19 , Quality of Life , Adolescent , Adult , Australia/epidemiology , COVID-19/epidemiology , Communicable Disease Control , Humans , Middle Aged , Pandemics , Self Report , Young Adult
3.
BMC Med Res Methodol ; 21(1): 172, 2021 08 17.
Article in English | MEDLINE | ID: covidwho-1365321

ABSTRACT

BACKGROUND: While web conferencing technologies are being widely used in communication and collaboration, their uptake in conducting research field work has been relatively slow. The benefits that these technologies offer researchers for engaging with hard-to-reach populations are beginning to be recognised, however, the acceptability and feasibility of using web conferencing technology to engage Aboriginal and Torres Strait Islander young people in research is unknown. OBJECTIVE: This study aims to evaluate whether the use of web conferencing to engage Aboriginal and Torres Strait Islander young people in research is an acceptable and feasible alternative to conventional face-to-face methods. METHODS: Aboriginal and Torres Strait Islander young people aged between 18 and 24 years were recruited via emails, flyers and snowballing to participate in an Online Yarning Circle (OYC) about wellbeing conducted via web conferencing. Five young Aboriginal and Torres Strait Islander Australians were trained as peer facilitators and each conducted one or more OYCs with support from an experienced Aboriginal and Torres Strait Islander researcher. The OYCs were recorded and the researchers conducted post-OYC interviews with the facilitators. OYC recordings, facilitator interviews and researchers' reflections about the method were analysed to assess acceptability and feasibility for use with this population. RESULTS: 11 OYCs were conducted with 21 participants. The evaluation focused on (a) acceptability of the method for participants and facilitators and (b) feasibility of data collection method and procedures for use in research. Our evaluation revealed good acceptability and feasibility of the method, with only minor challenges experienced, which were predominantly logistical in nature and related to scheduling, obtaining documentation of consent, and technical issues. These challenges were offset by the greater control over the level of engagement that was comfortable for individual participants and the greater ease with which they felt they could withdraw from participating. This shift in the traditional researcher-participant power dynamic was recognised by both participants and peer facilitators and was regarded as a support for Aboriginal and Torres Strait Islander young people's participation in research. CONCLUSIONS: The use of web conferencing to engage Aboriginal and Torres Strait Islander young people in research offers an acceptable and feasible alternative to face-to-face research methods. The benefits conferred by these technologies associated with yielding greater control and power to the research participant has broad relevance to research with marginalised populations.


Subject(s)
Research Personnel , Adolescent , Adult , Australia , Feasibility Studies , Humans , Young Adult
4.
BMJ Open ; 11(7): e048395, 2021 07 26.
Article in English | MEDLINE | ID: covidwho-1327672

ABSTRACT

INTRODUCTION: One in three people aged 65 years and over fall each year. The health, economic and personal impact of falls will grow substantially in the coming years due to population ageing. Developing and implementing cost-effective strategies to prevent falls and mobility problems among older people is therefore an urgent public health challenge. StandingTall is a low-cost, unsupervised, home-based balance exercise programme delivered through a computer or tablet. StandingTall has a simple user-interface that incorporates physical and behavioural elements designed to promote compliance. A large randomised controlled trial in 503 community-dwelling older people has shown that StandingTall is safe, has high adherence rates and is effective in improving balance and reducing falls. The current project targets a major need for older people and will address the final steps needed to scale this innovative technology for widespread use by older people across Australia and internationally. METHODS AND ANALYSIS: This project will endeavour to recruit 300 participants across three sites in Australia and 100 participants in the UK. The aim of the study is to evaluate the implementation of StandingTall into the community and health service settings in Australia and the UK. The nested process evaluation will use both quantitative and qualitative methods to explore uptake and acceptability of the StandingTall programme and associated resources. The primary outcome is participant adherence to the StandingTall programme over 6 months. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the South East Sydney Local Health District Human Research Ethics Committee (HREC reference 18/288) in Australia and the North West- Greater Manchester South Research Ethics Committee (IRAS ID: 268954) in the UK. Dissemination will be via publications, conferences, newsletter articles, social media, talks to clinicians and consumers and meetings with health departments/managers. TRIAL REGISTRATION NUMBER: ACTRN12619001329156.


Subject(s)
Exercise Therapy , Independent Living , Aged , Australia , Cost-Benefit Analysis , Humans , Randomized Controlled Trials as Topic
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