UMIN-CTR Clinical Trial

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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