UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054918 |
|---|---|
| Receipt number | R000062746 |
| Scientific Title | Effect of Information and Communication Technology-based Smart Care Services for Physical and Cognitive Functions in Older Adults Living Alone |
| Date of disclosure of the study information | 2024/07/09 |
| Last modified on | 2024/07/09 18:21:50 |
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Basic information
Public title
Smart Care Services for Integrated Care in Busan Metropolitan City
Acronym
Smart Care for Integrated Care in Busan Metropolitan City
Scientific Title
Effect of Information and Communication Technology-based Smart Care Services for Physical and Cognitive Functions in Older Adults Living Alone
Scientific Title:Acronym
ICT-based Smart Care for Older adults Living Alone
Region
| Asia(except Japan) |
Condition
Condition
Older adults living alone in Busan Metropolitan City
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To develop and verify the effectiveness of a smart care exercise service model for integrated care in Busan Metropolitan City.
2. To evaluate the effectiveness of smart composite exercise intervention on improving physical and cognitive functions in older adults living alone, using ICT-based systems to collect health information.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Comparison of Short Physical Performance Battery (SPPB) scores between the smart composite exercise intervention group (experimental group) and the non-intervention group (control group).
2. Comparison of Digit Span Test Forward (DST-F) and Backward (DST-B) scores between the experimental and control groups.
3. Comparison of Korean mini-mental state examination (K-MMSE) scores between the experimental and control groups.
4. Changes in SPPB scores before and after the intervention in the experimental group.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Intervention: ICT-based smart care services with personalized exercise video application
Control: Regular telephone consultations to monitor health status
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
| 65 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Aged 65-99 years
2. Residents of Busan
3. Living alone in their own house
4. Eligible for long-term care insurance benefits
Key exclusion criteria
1. Non-residents of Busan
2. Severe dementia, cancer (unhealed or within 5 years of recovery with high risk of recurrence or metastasis)
3. Full-body paralysis (unable to move without assistance)
4. Mental illnesses (diagnosed depression, schizophrenia, etc.) that prevent use or management of smart care devices
5. Inability to communicate or participate in health-related surveys
6. Unwillingness to provide data for tests or surveys
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Jong-Hwan |
| Middle name | |
| Last name | Park |
Organization
Pusan National University Hospital
Division name
Health Convergence Medicine Laboratory, Biomedical Research Institute
Zip code
49241
Address
179, Gudeok-Ro, Seo-Gu, Busan
TEL
82-51-240-7071
jpark@pnuh.co.kr
Public contact
Name of contact person
| 1st name | Ting-Fu |
| Middle name | |
| Last name | Lai |
Organization
Pusan National University Hospital
Division name
Health Convergence Medicine Laboratory, Biomedical Research Institute
Zip code
49241
Address
179, Gudeok-Ro, Seo-Gu, Busan
TEL
82-51-240-7071
Homepage URL
tingfu@pnuh.co.kr
Sponsor or person
Institute
Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea
Institute
Department
Personal name
Funding Source
Organization
Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Pusan National University Hospital Institutional Review Board
Address
179, Gudeok-Ro, Seo-Gu, Busan
Tel
82-51-240-7257
services@pusan.ac.kr
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
| 2024 | Year | 07 | Month | 09 | 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
200
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
Completed
Date of protocol fixation
| 2023 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 09 | Day |
Last modified on
| 2024 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062746
| Research Plan | |
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| Registered date | File name |
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