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
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
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
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
