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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000043245
Receipt No. R000049032
Scientific Title The effect of a multimodal comprehensive care methodology for family caregivers of people with dementia
Date of disclosure of the study information 2021/02/04
Last modified on 2021/02/04

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Basic information
Public title The effect of a multimodal comprehensive care methodology for family caregivers of
people with dementia
Acronym The effect of a multimodal comprehensive care methodology for family caregivers of
people with dementia
Scientific Title The effect of a multimodal comprehensive care methodology for family caregivers of
people with dementia
Scientific Title:Acronym The effect of a multimodal comprehensive care methodology for family caregivers of
people with dementia
Region
Japan

Condition
Condition dementia
Classification by specialty
Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy of a multimodal comprehensive care methodology training program for the family caregivers of people with dementia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Care burden of family caregivers at 3 months after the training program.
Key secondary outcomes Behavioral and Psychological Symptoms of Dementia at 3 months after the training program.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Monthly 2-hours training workshop of care communication for 3 months.
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria Family caregivers who are taking care of people with dementia within the fourth degree.
Key exclusion criteria A person who does not give written consent.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Miwako
Middle name
Last name Honda
Organization National Hospital Organization Tokyo Medical Center
Division name Division of Geriatric Research
Zip code 1520021
Address 2-5-1 Higashigaoka, Meguro, Tokyo
TEL 03-3411-0111
Email honda-1@umin.ac.jp

Public contact
Name of contact person
1st name Miwako
Middle name
Last name Honda
Organization National Hospital Organization Tokyo Medical Center
Division name Division of Geriatric Research
Zip code 1520021
Address 2-5-1 Higashigaoka, Meguro, Tokyo
TEL 03-3411-0111
Homepage URL
Email honda-1@umin.ac.jp

Sponsor
Institute National Hospital Organization Tokyo Medical Center
Institute
Department

Funding Source
Organization Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization National Hospital Organization Tokyo Medical Center
Address 2-5-1 Higashigaoka, Meguro, Tokyo
Tel 03-3411-0111
Email honda-1@umin.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
2021 Year 02 Month 04 Day

Related information
URL releasing protocol https://tmcgrc.org/protocol/index.html
Publication of results Unpublished

Result
URL related to results and publications https://tmcgrc.org/protocol/index.html
Number of participants that the trial has enrolled 148
Results 148 participants enrolled the study. A total of 117 family caregivers (79%) completed the study. The mean care burden scores before, one month after, and three months after the intervention were 13.3, 10.9 and 10.6, respectively (P<0.001). The mean Behave-AD score of 101 people with dementia (68%) three months post-training was lower than that at pre-training, but the difference was not statistically significant (from 13.6 to 11.8, P=0.005).
Results date posted
2021 Year 02 Month 04 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics primary family caregiver for a patient clinically diagnosed dementia and residing with the patient
Participant flow Participants were recruited from a community. After written consent obtained, each participant received monthly training for three months and received 12 weekly postcard informational packets. Care burden of the participants and behavioral pathological symptom of dementia of the care receivers were evaluated at the enrollment and month 3.
Adverse events none
Outcome measures Japanese short version of the Zarit Burden Interview
Behavioral Pathology in Alzheimer's Disease
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 07 Month 01 Day
Date of IRB
2016 Year 08 Month 16 Day
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
2018 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
2021 Year 02 Month 04 Day
Last modified on
2021 Year 02 Month 04 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049032

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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