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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042463
Receipt No. R000048471
Scientific Title Effectiveness of web-based intervention for life change adaptation in family caregivers of community-dwelling individuals with acquired brain injury: a cluster randomized controlled trial
Date of disclosure of the study information 2020/12/31
Last modified on 2021/05/19

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Basic information
Public title Effectiveness of web-based intervention for life change adaptation in family caregivers of community-dwelling individuals with acquired brain injury: a cluster randomized controlled trial
Acronym Effectiveness of web-based intervention for life change adaptation in family caregivers of community-dwelling individuals with acquired brain injury
Scientific Title Effectiveness of web-based intervention for life change adaptation in family caregivers of community-dwelling individuals with acquired brain injury: a cluster randomized controlled trial
Scientific Title:Acronym Effectiveness of web-based intervention for life change adaptation in family caregivers of community-dwelling individuals with acquired brain injury
Region
Japan

Condition
Condition family caregivers of individuals with acquired brain injury
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aimed to develop the web based program for life change adaptation in family caregivers of individuals with ABI and examine its efficacy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The life change adaptation scale(LCAS) (Shindo & Tadaka, 2020)
Key secondary outcomes The Multidimensional Scale of Perceived Social Support (MSPSS)(Iwasa et al., 2007)
The Positive Appraisal of Care scale (PAC)(Yamamoto-Mitani et al., 2001; Yamamoto et al., 2002)




Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Distribution of invitation leaflets and survey forms for the WEB-based My Mapping Program.
Education for eco-mapping(15 minutes a time / once a day)
Review and share the experience of giving and receiving social support depicted on their own eco-map (30 day)
Usual support at the family association for families of the individuals with acquired brain injury.
Interventions/Control_2 Usual support at the family association for families of the individuals with acquired brain injury.
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
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria The study`s inclusion criteria for family associations as follows:
1.A family association aim at supporting the families of individuals with acquired brain injury (ABI) in the community, 2.The establishment of a family association is open to the public, 3.More than 15 members. 4.Understanding the purpose of the research and voluntarily obtaining written consent to participate in the research.

The study`s inclusion criteria for family caregivers as follows:
1.older than 19 years, 2.having relatives of a family with an individual with ABI , 3.the individual with ABI have be evaluated from a doctor, and 4.It is judged by the family association manager that it is possible to participate in this study, 5.Understanding the purpose of the research and voluntarily obtaining written consent to participate in the research.

Key exclusion criteria The following exclusion criteria also had to be met for family associations: 1.A family association do not aim at supporting the families of individuals with acquired brain injury (ABI) in the community, 2.The establishment of a family association is not open to the public, 3.More than 15 members. 4.Do not understanding the purpose of the research and voluntarily obtaining written consent to participate in the research.

The following exclusion criteria also had to be met for family caregivers:
1.younger than 19 years, 2.Not having relatives of a family with an individual with ABI , 3.the individual with ABI have not be evaluated from a doctor, and 4.It is not judged by the family association manager that it is possible to participate in this study, 5.Do not understanding the purpose of the research and voluntarily obtaining written consent to participate in the research.
Target sample size 270

Research contact person
Name of lead principal investigator
1st name Yuka
Middle name
Last name IWATA
Organization School of Medicine, Yokohama City University
Division name Department of Community Health Nursing
Zip code 236-0004
Address 3-9, Hukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL 0457872973
Email iwata.yuk.go@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name Yuka
Middle name
Last name IWATA
Organization School of Medicine, Yokohama City University
Division name Department of Community Health Nursing
Zip code 236-0004
Address 3-9, Hukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL 0457872973
Homepage URL
Email iwata.yuk.go@yokohama-cu.ac.jp

Sponsor
Institute Department of Community Health Nursing, School of Medicine, Yokohama City University
Institute
Department

Funding Source
Organization Department of Community Health Nursing, School of Medicine, Yokohama City University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Department of Community Health Nursing, School of Medicine, Yokohama City University
Address 3-9, Hukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
Tel 0457872973
Email iwata.yuk.go@yokohama-cu.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 12 Month 31 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 12 Month 31 Day
Date of IRB
Anticipated trial start date
2020 Year 12 Month 31 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 11 Month 16 Day
Last modified on
2021 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048471

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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