iSupport-J, Japanese version of an internet-based self-learning and psychological assessment program, for dementia caregivers: study protocol for a randomized, waitlist-controlled study

BackgroundThe number of people with dementia in Japan will estimate to increase to roughly 20% of those aged 65 and over (approximately 7 million people) by 2025. Around the world, the number of people with dementia is increasing by 7.7 million per year, and caregivers depression, stress, social isolation, and sleep disorders due to the burden of caregiving are also increasing. Economic losses worldwide due to physical and mental health problems of dementia caregivers, reduced work hours due to caregiving, and job loss are estimated to be $252 billion in 2010. In addition, the risk of abuse against the caregiver increases as the caregiver is affected by physical and mental illness. Psychosocial interventions such as cognitive behavioral therapy have reportedly reduced caregivers mental distress and improved their health. Since caregivers have significant time and physical limitations due to caregiving, it is promising that interventions using the internet, which have few limitations in terms of location and time, will be helpful, along with its low cost. MethodsThis is a two-arm, randomized, waitlist-controlled trial. Participants will be randomized with a 1:1 ratio to either the immediate or late access group. The early intervention group will be able to use iSupport for three months, followed by allocation and follow-ups until six months. In the waitlist group, iSupport can be available for three months from the end of the Month 3 evaluation. Scheduled evaluation periods are Months 1, 3, and 6. DiscussionWe plan to begin recruiting for the trial in January 2021. We plan to finish the inclusion by June 2021 and complete all data collection by December 2021. Once all data collection is complete, we plan to analyze the data by April 2022; we aim to publish the results in a manuscript by the end of 2022. Trial RegistrationUMIN-CTR, UMIN000042957, registered on January 9, 2021.