UMIN-CTR Clinical Trial

Basic information
Public title	Effect of positive photo appreciation program on prevention of depression in older adults with mild cognitive impairment and early stage alzheimer disease: a randomized controlled trial
Acronym	Prevention of depression by interactive photo appreciation program
Scientific Title	Effect of positive photo appreciation program on prevention of depression in older adults with mild cognitive impairment and early stage alzheimer disease: a randomized controlled trial
Scientific Title:Acronym	Prevention of depression by interactive photo appreciation program
Region	Japan

Condition
Condition	older adults with mild cognitive impairment and early stage alzheimer disease
Classification by specialty	Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to clarify the effects of positive photo appreciation program on depressive symptom in older adults with mild cognitive impairment and mild alzheimer disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Depression
Key secondary outcomes	Cognitive function Depression in older adults Positive and negative emotion Motivation Instrumental activities of daily living Activities of daily living Quality of life in Dementia neuropsychiatric disease in Dementia

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Interventions: Interactive photo appreciation program, 3 months
Interventions/Control_2	Control: Photo education by text, 3 months
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	65 years-old <=
Age-upper limit	84 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Men and women clinically diagnosed with MCI or early stage Alzheimer's type dementia between 65 years old and 84 years old. 2)Persons who give informed consent by document
Key exclusion criteria	1)Persons who are taking psychotropic drugs and anti-depressants(anti-anxiety drug and sleeping drug are excluded) 2)Persons who had cerebrovascular disease, myocardial infarction or angina attack within past six months 3)Persons with progressive diseases such as cancer, depression and advanced visual impairment 4)Persons who are judged inappropriate for the intervention by the principal investigator
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Masumi Middle name Last name Masumi Ishihara
Organization	National Center for Geriatrics and Gerontology
Division name	Dept. Social Science, Center for Gerontology and Social Science
Zip code	474-8511
Address	7-430, Morioka-cho, Obu-shi, Aichi, 474-8511 JAPAN
TEL	0562462311
Email	ishihara@ncgg.go.jp

Public contact
Name of contact person	1st name Masumi Middle name Last name Ishihara
Organization	National Center for Geriatrics and Gerontology
Division name	Dept. Social Science, Center for Gerontology and Social Science
Zip code	474-8511
Address	7-430, Morioka-cho, Obu-shi, Aichi, 474-8511 JAPAN
TEL	81-562-46-2311
Homepage URL
Email	ishihara@ncgg.go.jp

Sponsor
Institute	National Center for Geriatrics and Gerontology Dept. Social Science, Center for Gerontology and Social Science
Institute
Department

Funding Source
Organization	Japan society for the promotion of science MEXTJapan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)	National Center for Geriatrics and Gerontology

IRB Contact (For public release)
Organization	National Center for Geriatrics and Gerontology
Address	7-430 Morioka-cho Obu City,Aichi Prefecture
Tel	81-562-46-2311(Ext.4683)
Email	yaday@ncgg.go.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	国立研究開発法人　国立長寿医療研究センター（愛知県） National Center for Geriatrics and Gerontology（Aichi prefecture）

Other administrative information
Date of disclosure of the study information	2018 Year 08 Month 29 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
Results
Results date posted
Results Delayed
Results Delay Reason
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	Open public recruiting
Date of protocol fixation	2018 Year 05 Month 17 Day
Date of IRB	2018 Year 10 Month 10 Day
Anticipated trial start date	2018 Year 10 Month 15 Day
Last follow-up date	2020 Year 12 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	2018 Year 08 Month 29 Day
Last modified on	2020 Year 06 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038668