UMIN-CTR Clinical Trial
| 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 | 2023/09/01 15:38:26 |
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Basic information
Public title
Evaluation of the effectiveness of iSupport Japanese version, an internet-based self-learning and psychological assessment program, for dementia caregivers
Acronym
iSupport-J Study
Scientific Title
Evaluation of the effectiveness of an internet-based self-learning and psychological assessment program for dementia caregivers
Scientific Title:Acronym
iSupport-J Study
Region
| Japan |
Condition
Condition
Caregivers of people with dementia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Caregiver's burden after 1 month, 3 months, and 6 months of using iSupport Japanese version
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
The intervention group will be provided with an online self-learning and support program using problem-solving techniques and cognitive behavioral therapy techniques for three months.
Interventions/Control_2
The waiting list group will wait for three months, followed by three months of an online self-learning support program.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The selection criteria include caring for a person with dementia and having access to 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 main analysis as the low care burden group, but will be evaluated exploratory.
Key exclusion criteria
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.
Target sample size
208
Research contact person
Name of lead principal investigator
| 1st name | Yoshie |
| Middle name | |
| Last name | Omachi |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Forensic Psychiatry
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL
042-341-2711
yomachi@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Yoshie |
| Middle name | |
| Last name | Omachi |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Forensic Psychiatry
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL
042-341-2711
Homepage URL
https://isupport-j.org
yomachi@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
MHLW
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Dokkyo Medical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, National Center of Neurology and Psychiatry
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
Tel
042-341-2711
rinri-jimu@ncnp.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
19GB1002
Org. issuing International ID_1
MHLW
Study ID_2
A2020-030
Org. issuing International ID_2
National Center of Neurology and Psychiatry
IND to MHLW
Institutions
Institutions
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）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 11 | Day |
Related information
URL releasing protocol
https://doi.org/10.1101/2022.11.16.22282333
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
376
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 09 | Day |
Last modified on
| 2023 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049040
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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