UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052266 |
|---|---|
| Receipt number | R000059036 |
| Scientific Title | Randomized controlled trial of mobile app-assisted educational intervention in older adults for disability prevention |
| Date of disclosure of the study information | 2023/09/21 |
| Last modified on | 2025/03/24 23:37:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Randomized controlled trial of mobile app-assisted educational intervention in older adults for disability prevention
Acronym
Randomized controlled trial of mobile app-assisted educational intervention in older adults for disability prevention
Scientific Title
Randomized controlled trial of mobile app-assisted educational intervention in older adults for disability prevention
Scientific Title:Acronym
Randomized controlled trial of mobile app-assisted educational intervention in older adults for disability prevention
Region
| Japan |
Condition
Condition
frailty
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
As the number of older adults requiring long-term care increases with the aging of society, disability prevention is an urgent issue. However, many older adults are not actively engaged in disability prevention on their own. It is said that environmental factors such as the impact of the new coronavirus epidemic, lack of knowledge about the disability prevention, and difficulties in going out prevent them from participating in disability prevention activities. Therefore, in order to encourage participation in disability prevention, it is considered important to provide appropriate information on disability prevention measures that can be implemented even in daily life.
The risk factors for requiring long-term care are roughly summarized in the following four areas: deterioration of physical functions, deterioration of activities of daily living, deterioration of oral functions, and deterioration of nutritional status. In order to maintain and improve the physical functions and quality of life of the older adults, it is important to support the implementation of preventive measures in these four areas, depending on the condition of the individual.
We have developed a smartphone application that supports the older adults in selecting and implementing disability preventive measures in these four areas according to their own conditions.
In this study, older adults who do not require nursing care will be provided with information on disability prevention using a smartphone application, and were asked to practice disaiblity prevention activities based on the information provided (intervention group). In addition, we set up a control group and compare the frequency of frailty/prefrailty with that of the intervention group in order to evaluate the effectiveness of providing information on disability prevention using the smartphone application.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The frequency of frailty/pre-frailty diagnosed with J-CHS criteria 3 months after the start of the intervention
Key secondary outcomes
days per week engaging in disability prevention
MoCA-J, Japanese version of the Montreal Cognitive Assessment
Walking speed, One-leg standing time, grip strength, body composition (weight, height, muscle mass, body fat percentage, muscle mass by limb), Barthel Index, Hand20
BMI (Body mass index), calf circumference, MNA-SF
Tongue Coating Score, Oral motility, Tongue pressure
Basic Checklist
SF8
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
intervention group (provision of information on disability prevention using the smartphone application)
Interventions/Control_2
control group (daily life as usual)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Persons who are 65 years of age or older at the time of obtaining consent.
2. A person who is able to walk (including the use of assistive devices).
3. Persons who can obtain written consent to participate in this study.
4. Persons who are able to operate a smart device.
Key exclusion criteria
1. Those who have been certified as requiring long term-care 1 to 5.
2. Those who have been diagnosed with dementia or have received anti-dementia medications.
3. Those who have significant fluctuations in cognitive and physical functions and/or require acute management.
4. Patients whose prognosis is judged by a physician to be within one year.
5. Other subjects for whom researchers determines that evaluation or intervention will be difficult.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Ishii |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-2018
sishii76@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsuko |
| Middle name | |
| Last name | Kawamura |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-2018
Homepage URL
akawa348@hiroshima-u.ac.jp
Sponsor or person
Institute
Shinya Ishii, Graduate School of Biomedical and Health Sciences, Hiroshima University
Institute
Department
Personal name
Ishii Shinya
Funding Source
Organization
self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
Tel
082-257-1551
iryo-sinsa@office.hiroshima-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
| 2023 | Year | 09 | Month | 21 | 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
Completed
Date of protocol fixation
| 2023 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 20 | Day |
Date of closure to data entry
| 2025 | Year | 02 | Month | 20 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 21 | Day |
Last modified on
| 2025 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059036
