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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033948
Receipt No. R000038668
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
Date of disclosure of the study information 2018/08/29
Last modified on 2018/08/29

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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
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
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
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
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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2018 Year 05 Month 17 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 15 Day
Last follow-up date
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
2018 Year 08 Month 29 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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