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

Background The 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. Methods This 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. Discussion We 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 Registration UMIN-CTR, UMIN000042957, registered on January 9, 2021. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial UMIN000042957 ### Funding Statement This research was supported by MHLW Research on Dementia Program Grant Number 19GB1002a, and Intramural Research Grant(30-3) for Neurological and Psychiatric Disorders of NCNP. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethics committee of National Center of Neurology and Psychiatry gave ethical approval for this work (A2020-030) I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors * ADQ : Approaches to Dementia Questionnaire CES-D : Center for Epidemiologic Study Depression Scale CONSORT : Consolidation Standards of Reporting Trials CSQ-8J : Client Satisfaction Questionnaire EQ-5D : EuroQol 5-Dimension GAD-7 : Generalized Anxiety Disorder scale-7-item GEE : Generalized estimating equations RCT : Randomized controlled trial T0 : Pre measurement T1 : First follow-up (1month) T2 : Second follow-up (3months) WHO : World Health Organization ZBI : Zarit Burden Interview