UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The investigation of the effect of educational program on the caregiver of a dementia patient
Title of the study (Brief title)	The investigation of the effect of educational program on the caregiver of a dementia patient
Region	Japan

Condition
Condition	Alzheimer's disease patients and their caregivers
Classification by specialty	Hematology and clinical oncology Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigate the change of the information about emotion and living of caregivers of Alzheimer's disease patients by the education program using our original booklet or a control booklet.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	We investigate the interaction between the difference booklets for educational program and the changes of the information about emotion and living of caregivers after a month of the educational program.
Key secondary outcomes	We investigate the relationships between the changes of the information about emotion and living of caregivers after a month of the educational program, and demographic data, neurocognitive/ neuropsychological tests results, and MRI data of Alzheimer's disease patients in clinical use.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	The educational program about dementia using our original booklet is performed once.
Interventions/Control_2	The educational program about dementia using a control booklet is performed once.
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	a) "Primary caregiver" of the outpatients in the psychiatric department of Nara medical university or Nara medical university hospital dementia-related disease medical center who are diagnosed as Alzheimer's disease based on DSM-5, asking for educational program about dementia. In the present study, we regarded relatives performing caregiving primarily and having an intimate knowledge of the patients developed over time, as "primary caregivers". b) No history or present diagnosis of any DSM-5 diagnosis or any neurological illness. c) The Alzheimer's disease patients of "primary caregivers" have the consent ability and consent to the application of their demographic data, neurocognitive/ neuropsychological tests results, and MRI data for the present study. d) >= 18 years of age
Key exclusion criteria	a) A history of head injury b) A diagnose of abuse or addiction of drugs
Target sample size	30

Research contact person
Name of lead principal investigator	Kiwamu Matsuoka
Organization	Nara medical university
Division name	The department of psychiatry
Address	840 Shijo-Cho, Kashihara, Nara
TEL	0744-22-3051
Email	kiwamu@naramed-u.ac.jp

Public contact
Name of contact person	Kiwamu Matsuoka
Organization	Nara medical university
Division name	The department of psychiatry
Address	840 Shijo-Cho, Kashihara, Nara
TEL	0744-22-3051
Homepage URL
Email	kiwamu@naramed-u.ac.jp

Sponsor
Institute	Nara medical university
Institute
Department

Funding Source
Organization	NIPPON LIFE INSURANCE FOUNDATION
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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

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	奈良県立医科大学付属病院(奈良県)

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 07 Day
Anticipated trial start date	2017 Year 03 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 03 Month 14 Day
Last modified on	2018 Year 03 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030492