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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034504
Receipt No. R000039172
Scientific Title Effects of active learning health education on older adults with limited health literacy
Date of disclosure of the study information 2018/10/21
Last modified on 2019/04/15

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Basic information
Public title Effects of active learning health education on older adults with limited health literacy
Acronym Effects of active learning on older adults with limited health literacy
Scientific Title Effects of active learning health education on older adults with limited health literacy
Scientific Title:Acronym Effects of active learning on older adults with limited health literacy
Region
Japan

Condition
Condition Community-dwelling older adults with limited health literacy
Classification by specialty
Geriatrics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of active learning education on comprehensive health literacy in older adults with limited health literacy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comprehensive health literacy
Key secondary outcomes 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 24 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. Having limited health literacy (European Health Literacy Survey Questionnaire total score of 33 or less)
2. Being independent in activity of daily living
3. 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 56

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuki Uemura
Organization Toyama Prefectural University
Division name Department of Liberal Arts and Sciences, Faculty of Engineering
Zip code
Address 5130 Kurokawa, Imizu, Toyama 939-0398, Japan
TEL 0766-56-7500(731)
Email kuemura@pu-toyama.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuki Uemura
Organization Toyama Prefectural University
Division name Department of Liberal Arts and Sciences, Faculty of Engineering
Zip code
Address 5130 Kurokawa, Imizu, Toyama 939-0398, Japan
TEL 0766-56-7500(731)
Homepage URL
Email kuemura@pu-toyama.ac.jp

Sponsor
Institute Toyama Prefectural University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 10 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 No longer recruiting
Date of protocol fixation
2018 Year 10 Month 01 Day
Date of IRB
2018 Year 10 Month 04 Day
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
2021 Year 11 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
2018 Year 10 Month 15 Day
Last modified on
2019 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=R000039172

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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