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

Abstract

Background: It is estimated that the number of people with dementia in Japan will 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 suffers from physical and mental illness. Psychosocial interventions such as cognitive behavioral therapy have been reported to reduce the mental distress of caregivers and improve their health. Since caregivers have significant time and physical limitations due to caregiving, it is expected that interventions using the Internet, which have few limitations in terms of location and time, will be useful, along with its low cost. Method: 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 3 months followed by allocation, and will be followed up until 6 months. In the waitlist group, iSupport can be used for 3 months from the end of Month 3 evaluation. Participants in both groups will be evaluated at Month 1, 3, and 6. Discussion: This study investigates the efficacy of iSupport-J system on caregivers's burden.

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

Data Availability

All data produced in the present study are available upon reasonable request to the authors

https://isupport-j.org/

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