UMIN-CTR Clinical Trial

Basic information
Public title	The effects of promoting interaction with separated families by using remote photo and video sharing devices on psychological and social functions in middle-aged and older adults: a feasibility study by before-after comparison
Acronym	The effects of remote photo and video sharing on psychological and social functions
Scientific Title	The effects of promoting interaction with separated families by using remote photo and video sharing devices on psychological and social functions in middle-aged and older adults: a feasibility study by before-after comparison
Scientific Title:Acronym	The effects of remote photo and video sharing on psychological and social functions
Region	Japan

Condition
Condition	Middle-aged and older people
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of using devices of sending and viewing photographs and videos on the psychological and social functions in middle-aged and older adults
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Dropout rate of subjects during the intervention
Key secondary outcomes	Satisfaction and burden of device usage, compliance rate of the intervention, depressive symptoms, loneliness, relationships with families living together, frequency of conversations with separated families and friends, frequency of device usage, and expressions about device usage

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	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Sharing and viewing photos and videos (at least once a week for 12 weeks)
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Persons who applied to participate in the study during the study perod
Key exclusion criteria	Regarding the target person (middle-aged and older people), persons under 50 years of age, persons who cannot install a device due to a lack of a TV at home or other reasons, and for whom intervention testing is difficult Regarding the subject's family members living separately, persons who have difficulty in intervention tests because they cannot share photographs or videos with the subject due to the lack of a smart-phone or other reasons, persons who have difficulty in sharing photographs or videos with the subject at least once a week
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Taiji Middle name Last name Noguchi
Organization	National Center for Geriatrics and Gerontology
Division name	Department of Social Science, Center for Gerontology and Social Science
Zip code	474-8511
Address	7-430 Morioka, Obu, Aichi 474-8511, Japan
TEL	0562-46-2311
Email	noguchi@ncgg.go.jp

Public contact
Name of contact person	1st name Taiji Middle name Last name Noguchi
Organization	National Center for Geriatrics and Gerontology
Division name	Department of Social Science, Center for Gerontology and Social Science
Zip code	474-8511
Address	7-430 Morioka, Obu, Aichi 474-8511, Japan
TEL	0562-46-2311
Homepage URL
Email	noguchi@ncgg.go.jp

Sponsor
Institute	National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization	Chikaku Corporation
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Chikaku Corporation
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Center for Geriatrics and Gerontology
Address	7-430 Morioka, Obu, Aichi 474-8511, Japan
Tel	0562-46-2311
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

Other administrative information
Date of disclosure of the study information	2020 Year 07 Month 27 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	2020 Year 06 Month 08 Day
Date of IRB	2020 Year 06 Month 08 Day
Anticipated trial start date	2020 Year 08 Month 01 Day
Last follow-up date	2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 07 Month 27 Day
Last modified on	2021 Year 07 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047068