UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057761 |
|---|---|
| Receipt number | R000066013 |
| Scientific Title | The effects of personal health records for frail prevention on physical function and health-related quality of life in older people: A randomized controlled trial. |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/11/03 08:41:09 |
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Basic information
Public title
The effects of personal health records for frail prevention on physical function and health-related quality of life in older people: A randomized controlled trial.
Acronym
Effects of Personal Health Records for the Prevention of Frail.
Scientific Title
The effects of personal health records for frail prevention on physical function and health-related quality of life in older people: A randomized controlled trial.
Scientific Title:Acronym
The effects of personal health records for frail prevention on physical function and health-related quality of life in older people: A randomized controlled trial.
Region
| Japan |
Condition
Condition
Frail
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effects of using personal health records for the prevention of frail on physical function and health-related quality of life in older people.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
health-related quality of life
Key secondary outcomes
Body weight, skeletal muscle mass, number of steps, grip strength, gait speed, sleep hours
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
PHR group: Self-management using a smartphone application.
Participants use a smartphone application to record daily data such as body weight, blood pressure, number of steps, meals, and hours of sleep.
The PHR group receives advice messages for frailty prevention via a smartphone application.
The intervention period is 6 months.
Interventions/Control_2
Control group: No intervention
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
| 85 | years-old | > |
Gender
Female
Key inclusion criteria
Age 65 years or older and under 85 years
Female
Not classified as frail by J-CHS criteria
Able to operate a smartphone
Provided written consent to participate in this study
Key exclusion criteria
Frail
Unable to operate a smartphone
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Mori |
Organization
Niigata University of Health and Welfare
Division name
Department of Health Science, Department of Health and Nutrition
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, 950-3198, JAPAN
TEL
0252574006
hiroyasu-mori@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Mori |
Organization
Niigata University of Health and Welfare
Division name
Department of Health Science, Department of Health and Nutrition
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, 950-3198, JAPAN
TEL
0252574006
Homepage URL
hiroyasu-mori@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
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
Ethics Approval Committee, Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, 950-3198, JAPAN
Tel
0252574455
rinri@nuhw.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
| 2025 | Year | 08 | 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
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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 02 | Day |
Last modified on
| 2025 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066013
