Abstract
BackgroundInformal 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.MethodsThe 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 education-only 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 self-administered 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-to-treat (ITT) protocol.DiscussionThis 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.Trial registrationClinicalTrials.gov, NCT04104568. Registered 26 September 2019.
Highlights
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
This paper describes the design of an intervention study to be carried out in Portugal to determine the effectiveness of a Portuguese culturally adapted version of an online training and support program for IC of PwD, on specified mental health and other well-being outcomes
The development of accessible, acceptable and effective training and support interventions for IC of PwD is a strategic priority in the global action plan on the public health response to dementia 2017–2025 [64]
Summary
Aims and research question The study follows an experimental parallel between-group design with two arms aiming to determine the effectiveness of an online training and support program (iSupport, European-Portuguese version), as compared to a minimal education-only intervention (e-book on dementia and caregiving issues), to decrease caregivers’ burden, symptoms of depression and anxiety, and to increase quality of life, positive aspects of caregiving and self-efficacy, in IC of PwD. A clinical evaluation of burden, anxiety and depression symptoms (inclusion criteria vi.) will not be conducted, instead these symptoms will be assessed by well-established self-report instruments (see sectionVariables and data collection methods) delivered via the study online platform. Together with access to the e-book, the participants allocated to the control group will receive weekly reminders to read the manual, as a measure to avoid bias due to different follow-up (as reminders are provided to the intervention group).
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