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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042957
Receipt No. 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 2021/01/09

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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) and 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 Psychiatry
Zip code 187-8551
Address 4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL 042-341-2711
Email 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 Psychiatry
Zip code 187-8551
Address 4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL 042-341-2711
Homepage URL
Email yomachi@ncnp.go.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Preinitiation
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
2025 Year 08 Month 10 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
2021 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049040

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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