UMIN-CTR Clinical Trial

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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049032