UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033948
Receipt number 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 2020/06/16 13:23:31

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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 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 or person

Institute

National Center for Geriatrics and Gerontology

Dept. Social Science, Center for Gerontology and Social Science

Institute

Department

Personal name



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

Value
https://center6.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