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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000038310
Receipt No. 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 2020/04/15

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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
Email kuemura@pu-toyama.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
Email kuemura@pu-toyama.ac.jp

Sponsor
Institute Toyama Prefectural University
Institute
Department

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
Email 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
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 Suspended
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
2020 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043635

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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