UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038310 |
|---|---|
| Receipt number | R000043635 |
| Scientific Title | Development and validation of preventive physical therapy using health literacy education for care prevention |
| Date of disclosure of the study information | 2019/10/17 |
| Last modified on | 2024/01/15 08:13:08 |
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Basic information
Public title
Development and validation of preventive physical therapy using health literacy education for care prevention
Acronym
Effects of health literacy education on care prevention in older adults
Scientific Title
Development and validation of preventive physical therapy using health literacy education for care prevention
Scientific Title:Acronym
Effects of health literacy education on care prevention in older adults
Region
| Japan |
Condition
Condition
Community-dwelling older adults
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the protective effects of health literacy education on functional decline in older adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional abilities in daily living
Key secondary outcomes
Health literacy
Physical function
Body composition
Cognitive function
Lifestyle (physical activity, diet)
Psychological outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: once-weekly active learning health education for 12 weeks
Interventions/Control_2
Control group: Lectures on health without active leaning and offering of brochures about health promotion
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. Being independent in basic activities of daily living
2. Being agreed with participation in the study
Key exclusion criteria
1. Diagnosed as dementia
2. Having serious disease which requires exercise limitation (i.e., cardiovascular, respiratory, neurological, ophthalmic, orthopedic disease)
3. Needing long-term care
Target sample size
286
Research contact person
Name of lead principal investigator
| 1st name | Kazuki |
| Middle name | |
| Last name | Uemura |
Organization
Toyama Prefectural University
Division name
Center for Liberal Arts and Sciences, Faculty of Engineering
Zip code
939-0398
Address
5180 Kurokawa, Imizu, Toyama 939-0398, Japan
TEL
0766-56-7500
kuemura@omu.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Uemura |
Organization
Toyama Prefectural University
Division name
Center for Liberal Arts and Sciences, Faculty of Engineering
Zip code
939-0398
Address
5180 Kurokawa, Imizu, Toyama 939-0398, Japan
TEL
0766-56-7500
Homepage URL
kuemura@omu.ac.jp
Sponsor or person
Institute
Toyama Prefectural University
Institute
Department
Personal name
Funding Source
Organization
Japanese Physical Therapy Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research ethics committee of Toyama Prefectural University
Address
5180 Kurokawa, Imizu, Toyama 939-0398, Japan
Tel
0766-56-7500
k-noto@pu-toyama.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
| 2019 | Year | 10 | Month | 17 | 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
141
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
| 2019 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2019 | Year | 10 | Month | 16 | Day |
Last modified on
| 2024 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043635
