UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035657
Receipt number R000040616
Scientific Title development of photo voice program to improve life functions of the elderly
Date of disclosure of the study information 2019/01/24
Last modified on 2024/03/08 12:53:17

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Basic information

Public title

development of photo voice program to improve life functions of the elderly

Acronym

development of photo voice program to improve life functions of the elderly

Scientific Title

development of photo voice program to improve life functions of the elderly

Scientific Title:Acronym

development of photo voice program to improve life functions of the elderly

Region

Japan


Condition

Condition

adult

Classification by specialty

Nursing Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

development of photo voice program to improve life functions of the elderly

Basic objectives2

Others

Basic objectives -Others

others

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

life functions

Key secondary outcomes

frequency of going out cognitive function
social network self-esteem satisfaction with social life depression Impressions


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

photo voice program/not photo voice program

Interventions/Control_2

not photo voice program/photo voice program

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

independent of daily life
normal comyunication ability

Key exclusion criteria

dependent of daily life

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Yukari
Middle name
Last name HATTORI

Organization

Asahikawa medical university

Division name

School of Medicine Department of Nursing

Zip code

078-8510

Address

asahikawa

TEL

0166-68-2111

Email

luna@asahikawa-med.ac.jp


Public contact

Name of contact person

1st name Yukari
Middle name
Last name HATTORI

Organization

Asahikawa medical university

Division name

School of Medicine Department of Nursing

Zip code

078-8510

Address

higashi2 1-1-1 midorigaoka asahikawa

TEL

0166-68-2111

Homepage URL


Email

luna@asahikawa-med.ac.jp


Sponsor or person

Institute

Asahikawa medical university

Institute

Department

Personal name



Funding Source

Organization

Asahikawa medical university

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Asahikawa Medical University Research Ethics Committee

Address

Higashi1,1-1-1,Midorigaoka,Asahikawa

Tel

0166-68-2187

Email

rs-kk.g@asahikawa-med.ac.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

旭川医科大学(北海道)


Other administrative information

Date of disclosure of the study information

2019 Year 01 Month 24 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

Delay expected

Results Delay Reason

Due to the corona disaster, data collection and analysis have not progressed as planned and results have been delayed.

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 07 Month 25 Day

Date of IRB


Anticipated trial start date

2019 Year 01 Month 25 Day

Last follow-up date

2019 Year 10 Month 31 Day

Date of closure to data entry

2019 Year 12 Month 31 Day

Date trial data considered complete

2020 Year 01 Month 20 Day

Date analysis concluded

2020 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2019 Year 01 Month 24 Day

Last modified on

2024 Year 03 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040616


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name