UMIN-CTR Clinical Trial

Basic information
Public title	The investigation and intervention of both social isolation and self management ability for MCI and dementia patients and their caregivers
Acronym	The investigation and intervention of both social isolation and self management ability for MCI and dementia patients
Scientific Title	The investigation and intervention of both social isolation and self management ability for MCI and dementia patients and their caregivers
Scientific Title:Acronym	The investigation and intervention of both social isolation and self management ability for MCI and dementia patients
Region	Japan

Condition
Condition	MCI , Dementia patients
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aimed to evaluate both social isolation and self management ability for MCI and dementia patients and their caregivers, and establish effective intervention.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Social support questionnaire, Coping questionnaire
Key secondary outcomes	Zarit Caregiver Burden Interview (ZBI) Mini-Mental State Examination (MMSE) Neuropsychiatry inventory (NPI) Quality of Life-Alzheimer's disease(QOL-AD)

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	Treatment
Type of intervention	Medicine Behavior,custom Maneuver
Interventions/Control_1	intervention therapy for caregivers
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	the chief caregiver of MCI and dementia patients, reliable informed consent could be obtained from the patient and or his her relatives
Key exclusion criteria	There was a previous history of mental illness, other findings in terms with the aims of this study
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Junko Middle name Last name Sato
Organization	Yagoto hospital
Division name	Psychiatry
Zip code	468 00073
Address	1-403 Shiogamaguchi, Tenpaku-ku, Nagoya-city,Aichi,468-0073,Japan
TEL	052-832-2111
Email	junko-sa@seirei.ac.jp

Public contact
Name of contact person	1st name Junko Middle name Last name Sato
Organization	Yagoto hospital
Division name	Psychiatry
Zip code	368-0073
Address	Shiogamaguchi, Tenpaku-ku, Nagoya-city,Aichi,468-0073,Japan
TEL	052-832-2111
Homepage URL
Email	junko-sa@seirei.ac.jp

Sponsor
Institute	Yagoto hospital
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	none
Name of secondary funder(s)	none

IRB Contact (For public release)
Organization	Yagoto
Address	Yagoto
Tel	052-832-2111
Email	hisyo@yagotohp.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	資生会　八事病院 (愛知県）

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 25 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	20
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	we can not commplete analysis
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	Completed
Date of protocol fixation	2016 Year 08 Month 31 Day
Date of IRB	2016 Year 09 Month 25 Day
Anticipated trial start date	2016 Year 09 Month 25 Day
Last follow-up date	2018 Year 03 Month 28 Day
Date of closure to data entry	2018 Year 03 Month 28 Day
Date trial data considered complete	2018 Year 03 Month 28 Day
Date analysis concluded	2018 Year 03 Month 28 Day

Other
Other related information

Management information
Registered date	2016 Year 09 Month 25 Day
Last modified on	2021 Year 05 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027817