Unique ID issued by UMIN | UMIN000042957 |
---|---|
Receipt number | R000049040 |
Scientific Title | Evaluation of the effectiveness of an internet-based self-learning and psychological assessment program for dementia caregivers |
Date of disclosure of the study information | 2021/01/11 |
Last modified on | 2025/02/04 20:42:52 |
Evaluation of the effectiveness of iSupport Japanese version, an internet-based self-learning and psychological assessment program, for dementia caregivers
iSupport-J Study
Evaluation of the effectiveness of an internet-based self-learning and psychological assessment program for dementia caregivers
iSupport-J Study
Japan |
Caregivers of people with dementia
Psychiatry |
Others
NO
The purpose of this study is to evaluate the effectiveness of iSupport Japanese version, an internet-based self-learning, developed by World Health Organization (WHO) for dementia caregivers. Furthermore, we will examine the usefulness of an online psychological assessment program that allows dementia caregivers to self-evaluate their sense of caregiver's burden, caregiving gratification, depression and anxiety.
Efficacy
Caregiver's burden after 1 month, 3 months, and 6 months of using iSupport Japanese version
Caregiving gratification, depression, anxiety, awareness of person-centered care, quality of life, and satisfaction with the application after 1 month, 3 months, and 6 months of using iSupport Japanese version
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
2
Educational,Counseling,Training
Behavior,custom | Maneuver |
For three months, the early intervention group will receive an online self-learning and support program using problem-solving and cognitive behavioral therapy techniques.
The waitlist group will wait for three months, followed by three months of an online self-learning support program.
18 | years-old | <= |
Not applicable |
Male and Female
The selection criteria include caring for a person with dementia and accessing the Internet. Those who score less than 20 points on the Zarit Burden Interview (ZBI) or less than 3 points on the Centre for Epidemiological Studies Depression (CES-D) Scale will be assessed on the same schedule as the intervention group, but will not be used in the primary analysis as the low care burden group, but will be evaluated exploratory.
Those who scored 26 points or more on the CES-D Scale or 15 points or more on the Generalized Anxiety Disorder-7 (GAD-7) will be excluded as a severe depression or anxiety.
208
1st name | Yoshie |
Middle name | |
Last name | Omachi |
National Center of Neurology and Psychiatry
Department of Forensic Psychiatry
187-8551
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
042-341-2711
yomachi@ncnp.go.jp
1st name | Yoshie |
Middle name | |
Last name | Omachi |
National Center of Neurology and Psychiatry
Department of Forensic Psychiatry
187-8551
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
042-341-2711
https://isupport-j.org
yomachi@ncnp.go.jp
National Center of Neurology and Psychiatry
MHLW
Japanese Governmental office
Dokkyo Medical University
Ethics Committee, National Center of Neurology and Psychiatry
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
042-341-2711
rinri-jimu@ncnp.go.jp
YES
19GB1002
MHLW
A2020-030
National Center of Neurology and Psychiatry
国立精神・神経医療研究センター病院(東京都)、獨協医科大学(栃木県)
2021 | Year | 01 | Month | 11 | Day |
https://doi.org/10.1101/2022.11.16.22282333
Partially published
https://www.ncnp.go.jp/common/cms/docs/cost_report_r5_3-3.pdf
240
Over 36 months, from January 2021 to January 2024, 240 people were randomized. The interim analysis was conducted when 3-month data were available for 80 patients in the early intervention group and 81 patients in the waitlist group. Analysis of the change in J-ZBI at 3 months between the early intervention and the wait-list groups showed a significant improvement in the early intervention group. The participant retention rate was 90.1%.
2025 | Year | 02 | Month | 04 | Day |
Of the 161 participants included in the interim analysis, 79.5% were female, and the average age at baseline was 58.6 years. The most common relationship with the person cared for was that of a daughter or son.
From January 2021 to May 2023, 240 participants enrolled in the study. They were randomly assigned to 121 in the early intervention group and 119 in the waitlist group.
None
The interim analysis was conducted when 3-month data were available for 80 patients in the early intervention group and 81 patients in the waitlist group. Analysis of the change in J-ZBI at 3 months between the early intervention and the wait-list groups showed a significant improvement in the early intervention group. The participant retention rate was 90.1%.
No longer recruiting
2020 | Year | 08 | Month | 11 | Day |
2020 | Year | 08 | Month | 11 | Day |
2021 | Year | 01 | Month | 11 | Day |
2024 | Year | 01 | Month | 16 | Day |
2021 | Year | 01 | Month | 09 | Day |
2025 | Year | 02 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049040