UMIN-CTR Clinical Trial

Basic information
Public title	The investigation and intervention of dementia caregivers based on the positive psychology
Acronym	The positive psychology for dementia caregivers
Scientific Title	The investigation and intervention of caregivers resilience based on the positive psychology for dementia patients and their caregivers
Scientific Title:Acronym	The intervention based on the positive psychology for dementia
Region	Japan

Condition
Condition	Dementia patients and caregivers
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aimed to evaluate various aspects of caregivers resilience based on the positive psychology for dementia patients and their caregivers, and establish effective new intervention.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	PGC Moral Scale Subjective Well-Being Scale
Key secondary outcomes	Zarit Caregiver Burden Interview (ZBI) Mini-Mental State Examination (MMSE) Quality of Life-Alzheimer's disease(QOL-AD) Strength Use Scale (SUS scale)

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	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	40 years-old <=
Age-upper limit	95 years-old >=
Gender	Male and Female
Key inclusion criteria	dementia patients and the chief caregiver of dementia patients, reliable informed consent could be obtained from the patient and or his or 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	40

Research contact person
Name of lead principal investigator	1st name Shutaro Middle name Last name Nakaaki
Organization	Minamichita Hospital
Division name	Psychiatry
Zip code	470-3411
Address	86 Ooaza Toyookaaza Magohazama,Chita-gun , Minamichita-cho,Aichi,470-3411,Japan
TEL	0569651111
Email	junko-sa@seirei.ac.jp

Public contact
Name of contact person	1st name Hirofumi Middle name Last name Sato
Organization	Minamichita Hospital
Division name	Psychiatry
Zip code	470-3411
Address	86 Ooaza Toyookaaza Magohazama,Chita-gun , Minamichita-cho,Aichi,470-3411,Japan
TEL	0569651111
Homepage URL
Email	makoto_tanaka_651111@kyoseikai.or.jp

Sponsor
Institute	Minamichita 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	Yagoto hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	the ethical committee of Michamichita Hospital
Address	86 Ooaza Toyookaaza Magohazama,Chita-gun , Minamichita-cho,Aichi,470-3411,Japan
Tel	0569 65 1111
Email	makoto_tanaka_651111@kyoseikai.or.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	南知多病院　（愛知県）

Other administrative information
Date of disclosure of the study information	2020 Year 08 Month 01 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	0
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	we interrupted this study
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	Terminated
Date of protocol fixation	2019 Year 04 Month 30 Day
Date of IRB	2019 Year 05 Month 16 Day
Anticipated trial start date	2020 Year 08 Month 01 Day
Last follow-up date	2021 Year 05 Month 02 Day
Date of closure to data entry	2023 Year 03 Month 31 Day
Date trial data considered complete	2023 Year 03 Month 31 Day
Date analysis concluded	2023 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2020 Year 06 Month 04 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=R000046385