UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044034
Receipt number R000050159
Scientific Title Study on the effectiveness of information technology-based health promotion programs for community dwelling older adults
Date of disclosure of the study information 2021/06/01
Last modified on 2022/11/02 11:17:43

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Basic information

Public title

Study on the effectiveness of information technology-based health promotion programs for community dwelling older adults

Acronym

The effectiveness of information technology-based health promotion programs

Scientific Title

Study on the effectiveness of information technology-based health promotion programs for community dwelling older adults

Scientific Title:Acronym

The effectiveness of information technology-based health promotion programs

Region

Japan


Condition

Condition

older adults

Classification by specialty

Geriatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the effects of a tablet-based education program about geriatric syndrome on the health and mental status of community-dwelling older adults, and to compare the effects with those of conventional projects.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Health consciousness of before and after the intervention.

Key secondary outcomes

The Activities of Daily Living (ADL), quality of life (QOL), the Geriatric Depression Scale (GDS-15), health literacy Survey Questionnaire (J-HLS-EU-Q47),the Lubben Social Network Scale, ICT usage status, the cognitive functions (MoCA-J, trail making test, etc), nutritional status.


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Received 4 months of IT-based health education and no intervention after 1 month of wash out period.

Interventions/Control_2

After a one-month wash-out period without intervention for four months, receive four months of IT-based health education.

Interventions/Control_3

Participate in face-to-face health classes in addition to traditional health classes.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

All older adults living in Minamichita-cho, over 65 years old

Those who understand the research content and obtained consent by writing

Key exclusion criteria

Individuals who do not have enough ability to fully agree on research participation

Individuals who have received nursing care certification

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Aiko
Middle name
Last name Inoue

Organization

Nagoya university

Division name

Institute of innovation for future society (Department of community health & geriatrics graduate school of medicine)

Zip code

466-8550

Address

65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan

TEL

052-744-2368

Email

chiharu83724@coi.nagoya-u.ac.jp


Public contact

Name of contact person

1st name Chiharu
Middle name
Last name Uno

Organization

Nagoya university

Division name

Institute of innovation for future society (Department of community health & geriatrics graduate sch

Zip code

466-8550

Address

65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan

TEL

052-744-2368

Homepage URL


Email

chiharu83724@coi.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya university
Institute of innovation for future society (Department of community health & geriatrics graduate school of medicine)

Institute

Department

Personal name



Funding Source

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor

Minamichita-cho, Chita-gun, Aichi Prefecture, Japan

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Etics Committee of the Nagoya University Graduate School of Medicine

Address

65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan

Tel

052-744-2973

Email

ethics@med.nagoya-u.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



Other administrative information

Date of disclosure of the study information

2021 Year 06 Month 01 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

110

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

No longer recruiting

Date of protocol fixation

2021 Year 05 Month 20 Day

Date of IRB

2021 Year 05 Month 28 Day

Anticipated trial start date

2021 Year 06 Month 01 Day

Last follow-up date

2022 Year 03 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

2021 Year 04 Month 25 Day

Last modified on

2022 Year 11 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050159


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name