Validation of the InnoWell Platform: Protocol for a Clinical Trial.

BACKGROUND: New electronic health technologies are being rapidly developed to improve the delivery of mental health care for both health professionals and consumers and better support self-management of care. We developed a Web-based platform (the InnoWell Platform) that supports the prevention, early intervention, treatment, and continuous monitoring of mental health and maintenance of well-being in people aged 2 years and older. The platform is a customizable digital tool kit that operates through existing service providers who utilize the system to provide their consumers with access to evidence-based assessments and feedback, intervention options, and outcome monitoring. It does this by collecting, storing, and reporting personal and health information back to consumers and their health professionals to promote collaborative care partnerships that aim to improve the management of mental ill health and maintenance of well-being. OBJECTIVE: The aim of this study was to describe the research protocol for a naturalistic prospective clinical trial wherein all consumers presenting for care to a traditional face-to-face or Web-based mental health service in which the InnoWell Platform is being offered as part of standard clinical care will be given the opportunity to use the platform. METHODS: The Web-based platform is a configurable and customizable digital tool that assists in the assessment, monitoring and management of mental ill health, and maintenance of well-being. It does this by collecting, storing, and reporting health information back to the person and his or her clinician to enable transformation to person-centered care. The clinical trial will be conducted with individuals aged 2 years and older presenting to participating services for care, including persons from the veteran community, Aboriginal and Torres Strait Islander people, people from culturally and linguistically diverse backgrounds, the lesbian, gay, bisexual, transgender, and intersex community, and those from broader education and workforce sectors, as well as people with disabilities, lived experience of comorbidity, complex disorders, and suicidality. RESULTS: Project Synergy was funded in June 2017, and data collection began in November 2018 at a youth mental health service. At the time of this publication, 5 additional services have also begun recruitment, including 4 youth mental health services and a veteran's service. The first results are expected to be submitted in 2020 for publication. CONCLUSIONS: This clinical trial will promote access to comprehensive, high-quality mental health care to improve outcomes for consumers and health professionals. The data collected will be used to validate a clinical staging algorithm designed to match consumers with the right level of care and reduce the rate of suicidal thoughts and/or behaviors and suicide by suggesting pathways to care that are appropriate for the identified level of need, while simultaneously enabling a timely service response. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry ACTRN12618001676202; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374632 (Archived by WebCite at http://www.webcitation.org/78TOi5jwl). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13955.

Disability in older adults across the continuum of cognitive decline: unique contributions of depression, sleep disturbance, cognitive deficits and medical burden.

OBJECTIVES: Disability in older adults is associated with a need for support in work, education, and community activities, reduced independence, and poorer quality of life. This study examines potential determinants of disability in a clinical sample of older adults across the continuum of cognitive decline, including sociodemographic, medical, psychiatric, and cognitive factors. DESIGN: This is a cross-sectional study. SETTING: Participants were recruited from a specialty clinic for adults "at risk" of or with early dementia (including subjective cognitive complaints, mild cognitive impairment, and early dementia). PARTICIPANTS: Four hundred forty-two older adults (mean age = 67.11, SD = 9.33) underwent comprehensive medical, neuropsychological, and mood assessments. MEASUREMENTS: Disability was assessed via the self-report World Health Organization Disability Assessment Schedule 2.0. A stepwise (forward) linear regression model was computed to determine factors that contribute to disability within this group. RESULTS: Depressive symptoms were the largest predictor, uniquely explaining 31.8% of the variance. Other contributing factors in the model included younger age, medical burden, and sleep quality, with all factors together accounting for a total of 50.4% of the variance in disability. Cognitive variables did not contribute to the model. CONCLUSIONS: Depressive symptoms account for a significant portion of the variance in disability, but other factors such as age, medical burden and sleep quality are also important contributors in older adults across the continuum of cognitive decline. The relative association of these variables with disability appears to differ for older (≥65 years) relative to younger (<65 years) participants. Given the relationship between disability and these risk factors, an integrative and multidisciplinary approach to risk reduction will likely be most effective, with potential carry over effects for physical and mental health.

Examining Internet and eHealth Practices and Preferences: Survey Study of Australian Older Adults With Subjective Memory Complaints, Mild Cognitive Impairment, or Dementia.

BACKGROUND: Interest in electronic health (eHealth) technologies to screen for and treat a variety of medical and mental health problems is growing exponentially. However, no studies to date have investigated the feasibility of using such e-tools for older adults with mild cognitive impairment (MCI) or dementia. OBJECTIVE: The objective of this study was to describe patterns of Internet use, as well as interest in and preferences for eHealth technologies among older adults with varying degrees of cognitive impairment. METHODS: A total of 221 participants (mean age=67.6 years) attending the Healthy Brain Ageing Clinic at the University of Sydney, a specialist mood and memory clinic for adults ≥50 years of age, underwent comprehensive clinical and neuropsychological assessment and completed a 20-item self-report survey investigating current technology use and interest in eHealth technologies. Descriptive statistics and Fisher exact tests were used to characterize the findings, including variability in the results based on demographic and diagnostic factors, with diagnoses including subjective cognitive impairment (SCI), MCI, and dementia. RESULTS: The sample comprised 27.6% (61/221) SCI, 62.0% (137/221) MCI, and 10.4% (23/221) dementia (mean Mini-Mental State Examination=28.2). The majority of participants reported using mobile phones (201/220, 91.4%) and computers (167/194, 86.1%) routinely, with most respondents having access to the Internet at home (204/220, 92.6%). Variability was evident in the use of computers, mobile phones, and health-related websites in relation to sociodemographic factors, with younger, employed respondents with higher levels of education being more likely to utilize these technologies. Whereas most respondents used email (196/217, 90.3%), the use of social media websites was relatively uncommon. The eHealth intervention of most interest to the broader sample was memory strategy training, with 82.7% (172/208) of participants reporting they would utilize this form of intervention. Preferences for other eHealth interventions varied in relation to educational level, with university-educated participants expressing greater interest in interventions related to mood (P=.01), socialization (P=.02), memory (P=.01), and computer-based exercises (P=.046). eHealth preferences also varied in association, with diagnosis for interventions targeting sleep (P=.01), nutrition (P=.004), vascular risk factors (P=.03), and memory (P=.02). CONCLUSIONS: Technology use is pervasive among older adults with cognitive impairment, though variability was noted in relation to age, education, vocational status, and diagnosis. There is also significant interest in Web-based interventions targeting cognition and memory, as well as other risk factors for cognitive decline, highlighting the urgent need for the development, implementation, and study of eHealth technologies tailored specifically to older adults, including those with MCI and early dementia. Strategies to promote eHealth use among older adults who are retired or have lower levels of education will also need to be considered.

The Beyond Ageing Project Phase 2--a double-blind, selective prevention, randomised, placebo-controlled trial of omega-3 fatty acids and sertraline in an older age cohort at risk for depression: study protocol for a randomized controlled trial.

BACKGROUND: Late-life depression is associated with high rates of morbidity, premature mortality, disability, functional decline, caregiver burden and increased health care costs. While clinical and public health approaches are focused on prevention or early intervention strategies, the ideal method of intervention remains unclear. No study has set out to evaluate the role of neurobiological agents in preventing depressive symptoms in older populations at risk of depression. METHODS/DESIGN: Subjects with previously reported sub-threshold depressive symptoms, aged 60 to 74 years, will be screened to participate in a single-centre, double-blind, randomised controlled trial with three parallel groups involving omega-3 fatty acid supplementation or sertraline hydrochloride, compared with matching placebo. Subjects will be excluded if they have current depression or suicide ideation; are taking antidepressants or any supplement containing omega-3 fatty acid; or have a prior history of stroke or other serious cerebrovascular or cardiovascular disease, neurological disease, significant psychiatric disease (other than depression) or neurodegenerative disease. The trial will consist of a 12 month treatment phase with follow-up at three months and 12 months to assess outcome events. At three months, subjects will undergo structural neuroimaging to assess whether treatment effects on depressive symptoms correlate with brain changes. Additionally, proton spectroscopy techniques will be used to capture brain-imaging markers of the biological effects of the interventions. The trial will be conducted in urban New South Wales, Australia, and will recruit a community-based sample of 450 adults. Using intention-to-treat methods, the primary endpoint is an absence of clinically relevant depression scores at 12 months between the omega-3 fatty acid and sertraline interventions and the placebo condition. DISCUSSION: The current health, social and economic costs of late-life depression make prevention imperative from a public health perspective. This innovative trial aims to address the long-neglected area of prevention of depression in older adults. The interventions are targeted to the pathophysiology of disease, and regardless of the effect size of treatment, the outcomes will offer major scientific advances regarding the neurobiological action of these agents. The main results are expected to be available in 2017. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12610000032055 (12 January 2010).