UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034504
Receipt number 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 2021/03/03 14:31:27

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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 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 or person

Institute

Toyama Prefectural University

Institute

Department

Personal name



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

Value
https://center6.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