Clinical evaluation of the Wandi Nerida Residential care facility.
Clinical evaluation of the Wandi Nerida Residential care facility for multidisciplinary residential care for people with eating disorders and effect on eating disorder symptoms including body image perception, body mass index (BMI), general mental and physical health and co-morbidities, health-related quality of life (HRQoL), and role impairment.
Western Sydney University
200 participants
Mar 1, 2022
Interventional
Conditions
Summary
The proposed study will comprise a 2-armed, 2-site, data-analytic blind clinical trial to determine the clinical effectiveness of the Wandi Nerida program. The data management site will be at the WSU Macarthur Clinical School. The recruitment and treatment sites will be at the Wandi Nerida program and the Royal Brisbane Hospital Day program. The project will be informed by a co-design and Participatory Action Research (PAR) approach. Over a 24-month period we have been advised to anticipate 120 Wandi Nerida participant and 46 Day Program participant separations. Continued recruitment for an additional 6 months would ensure a minimum of 60 participants per group. This estimate this will allow for a mean difference medium effect size of .5 for eating disorder symptoms severity or other continuous outcomes using Cohen’s table. The number who do not engage with and/or do not complete (leave within 4 weeks of treatment) at the Wandi Nerida program is unknown at this stage.The data set for the Clinical Evaluation will include but is not limited to measures on: eating disorder diagnosis prior to residential treatment; body mass index; psychopathology; ability to complete daily activities; related mental health and wellbeing scores (comorbidities); and QALY estimates. The research will extend upon the minimum data set developed by the Federal Technical Advisory Group (TAG) to also include measures that assess outcomes related to (1) the unique aspects of the B-FREEDT model of care through qualitative exploration, (2) the testing of key indicators for measuring change, (3) changes in concurrent and ongoing healthcare utilisation, (4) stakeholders other than the clients themselves and extending to family members and clinicians inside and external to Wandi Nerida, and (4) the monitoring of clinical outcomes of clients and their families over six months from start of treatment. Notably only the data pertaining to primary outcomes will be collected a the control site.
Eligibility
Inclusion Criteria1
- All people admitted to either program and consenting to participate in research assessments.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
The Residential program: Wandi Nerida is an intensive multidisciplinary (medical, psychological, nutritional and supportive with supervision of meals) program of care that has the unique feature of promoting person-centred and least restrictive care and a high level of lived experience informed therapy and health care providers for people with eating disorders. There are an anticipated 60-70 separations on an annual basis. Participants will have completed at least 4-weeks of the Wandi Nerida program, and most an 8-week program. The Wandi Nerida program of care will be available as usual to those who do not participate in this study. Health information and experiences at the facility will be collected via online surveys (around 30-40 minutes each time). Participants will be asked to complete (1) quantitative and qualitative psychometric measures at 5 different time points (pre-treatment, 4 weeks, 8 weeks, 3 months post-treatment, 6 months post-treatment) and (2) weekly symptoms via online survey (about 15 minutes) for each week they are at the program and (3). All will be invited to an additional interview of 30-60 minutes that comprises (1) completing a short structured interview to gather demographic, diagnostic and past treatment information and (2) participating in a semi-structured interview exploring their experiences of care. Participant carer's will also be asked to complete quantitative and qualitative psychometric measures via online survey at 3 different time points (pre-treatment, 8 weeks/discharge, 3 months post-treatment): (1) at baseline online self-report questionnaires (taking about 30 minutes) assessing caregiver burden, distress, use of health services, quality of life, and and expectations for treatment; (2) at 8 weeks/discharge self-report questionnaire assessing treatment satisfaction and qualitative questions that relate to treatment experiences (about 20 minutes).; and (3) at 3-months post discharge quantitative self-report questionnaires (about 30 minutes) assessing caregiver burden, distress, and quality of life. Cares (about 10) also will also be invited to an indepth semi-structured interview (of 30-60 minutes) with particular interest in how the individual carer/parent/spouse experienced and ascribes meaning to their and their family’s experiences of the Wanda Nerida program. Healthcare providers (up to 10) at Wandi Nerida residential program will be invited to a semi -structured interview of 30-60 minutes with particular interest in the health care provider’s experiences, perception and satisfaction with care during their time working at the Wandi Nerida program
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12621001651875