The holistic policy and intervention framework for global mental health reflects an iterative learning process that can be applied and scaled up across different settings through appropriate modifications.
Background: Informal caregivers (IC) of people with dementia (PwD) are at greater risk of developing physical and mental health problems when compared to the general population and to IC of people with other chronic diseases. Internet-based interventions have been explored for their potential to minimize the negative effects of caring, accounting for their ubiquitous nature, convenient delivery, potential scalability and presumed (cost) effectiveness. iSupport is a self-help online program developed by the World Health Organization (WHO) to provide education, skills training and support to IC of PwD. This paper describes the design of an intervention study aimed at determining the effectiveness of a Portuguese culturally adapted version of iSupport on mental health and other well-being outcomes. Methods: The study follows an experimental parallel between-group design with two arms: access to the five modules and twenty-three lessons of "iSupport" for three months (intervention group); or access to an educationonly e-book (comparison group). One hundred and eighty four participants will be recruited by referral from national associations. Inclusion criteria are: being 18 years or older and provide e-consent; being a self-reported non-paid caregiver for at least six months; of a person with a formal diagnosis of dementia; being skilled to use internet; and experience a clinically relevant level of burden (≥ 21 on Zarit Burden Interview) or depression or anxiety symptoms (≥ 8 on Hospital Anxiety and Depression Scale). Data is collected online, resorting to selfadministered instruments, at baseline, 3 and 6 months after baseline. The primary outcome is caregiver burden, measured by the Zarit Burden Interview. Symptoms of depression and anxiety, quality of life, positive aspects of caregiving and general self-efficacy are secondary study outcomes. The data analysis will follow an Intention-totreat (ITT) protocol. Discussion: This protocol is an important resource for the many organizations in several countries aiming to replicate iSupport. Findings from this intervention study will offer evidence to bolster an informed decision making on scaling up iSupport as a new intervention program with minimal costs aimed at minimizing the psychological distress of IC of PwD in Portugal and elsewhere.
Background Dementia is a global public health priority with an estimated prevalence of 150 million by 2050, nearly two-thirds of whom will live in the Asia-Pacific region. Dementia creates significant care needs for people with the disease, their families, and carers. iSupport is a self-help platform developed by the World Health Organization (WHO) to provide education, skills training, and support to dementia carers. It has been adapted in some contexts (Australia, India, the Netherlands, and Portugal). Carers using the existing adapted versions have identified the need to have a more user-friendly version that enables them to identify solutions for immediate problems quickly in real time. The iSupport virtual assistant (iSupport VA) is being developed to address this gap and will be evaluated in a randomized controlled trial (RCT). Objective This paper reports the protocol of a pilot RCT evaluating the iSupport VA. Methods Seven versions of iSupport VA will be evaluated in Australia, Indonesia, New Zealand, and Vietnam in a pilot RCT. Feasibility, acceptability, intention to use, and preliminary impact on carer-perceived stress of the iSupport VA intervention will be assessed. Results This study was funded by the e-ASIA Joint Research Program in November 2020. From January to July 2023, we will enroll 140 dementia carers (20 carers per iSupport VA version) for the pilot RCT. The study has been approved by the Human Research Committee, University of South Australia, Australia (203455). Conclusions This protocol outlines how a technologically enhanced version of the WHO iSupport program—the iSupport VA—will be evaluated. The findings from this intervention study will provide evidence on the feasibility and acceptability of the iSupport VA intervention, which will be the basis for conducting a full RCT to assess the effectiveness of the iSupport VA. The study will be an important reference for countries planning to adapt and enhance the WHO iSupport program using digital health solutions. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12621001452886; https://tinyurl.com/afum5tjz International Registered Report Identifier (IRRID) PRR1-10.2196/33572
BACKGROUND Dementia is a global public health priority with prevalence estimated to be 150 million by 2050; nearly two-thirds of whom will live in the Asia Pacific region. Dementia creates significant care needs for people with the disease, their families and carers. iSupport is a self-help platform developed by the World Health Organization to provide education, skills training and support to dementia carers. It has been adapted in some contexts (Australia, India, Netherland and Portugal). Carers using the existing adapted versions have identified the need to have a more user-friendly version that enables them to identify solutions for immediate problems in real-time quickly. The iSupport virtual assistant (iSupport VA) is being developed to address this gap and will be evaluated in a randomized controlled trial (RCT). OBJECTIVE This protocol outlines how a technologically enhanced version of the WHO iSupport program - the iSupport VA will be evaluated METHODS Seven versions of iSupport VA will be evaluated in Australia, Indonesia, New Zealand and Vietnam using a pilot RCT involving 140 carers (20 carers per iSupport VA version). Feasibility, acceptability, intention to use, and preliminary impact on carer perceived stress of the iSupport VA intervention will be assessed RESULTS Study findings from this intervention study will provide evidence on the feasibility and acceptability of the iSupport VA intervention, which will be the basis for conducting a full RCT to assess the effectiveness of the iSupport VA. CONCLUSIONS The study will be an important reference for countries planning to adapt and enhance the WHO iSupport program using digital health solutions. CLINICALTRIAL Australian New Zealand Clinical Trial (http://www.anzctr.org.au), Identifier: 381146.
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