UMIN-CTR Clinical Trial

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 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	5130 Kurokawa, Imizu, Toyama, Japan
TEL	0766-56-7500(1731)
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	5130 Kurokawa, Imizu, Toyama 939-0398, Japan
TEL	0766-56-7500(1731)
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	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	2018 Year 10 Month 21 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://doi.org/10.1159/000511357
Number of participants that the trial has enrolled	60
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	Main results already published
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	2021 Year 03 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039172