UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042989
Receipt No. R000049080
Scientific Title Translation, cross-cultural adaptation, and validation of the Japanese version of The Patient Education Materials Assessment Tool (PEMAT)
Date of disclosure of the study information 2021/01/13
Last modified on 2021/01/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Evaluation of Understandability and Actionability of Patient Education Materials
Acronym Evaluation of Understandability and Actionability of Patient Education Materials
Scientific Title Translation, cross-cultural adaptation, and validation of the Japanese version of The Patient Education Materials Assessment Tool (PEMAT)
Scientific Title:Acronym Translation, cross-cultural adaptation, and validation of the Japanese version of The Patient Education Materials Assessment Tool (PEMAT)
Region
Japan

Condition
Condition Patient education materials
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The Patient Education Materials Assessment Tool (PEMAT) was developed by the Agency for Healthcare Research and Quality (AHRQ) to systematically assess the understandability and actionability of patient education materials. It helps clinicians to select understandable and actionable materials from a wide variety of patient education materials, such as pamphlets, websites, and videos.
In Japan, various patient-oriented materials are used in the medical field, but whether these materials are easy for patients to understand and change their behavior has not been fully verified.
Therefore, in this study, we will develop a Japanese version of PEMAT and conduct an internet survey of the general public with the aim of verifying its reliability and validity.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Understandability and actionability of the patient education materials
Key secondary outcomes Stages of behavioral change, self-efficacy, behavioral intention

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 4
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention 1: the participants are provided with a printable patient education material with high PEMAT scores.
Interventions/Control_2 Control 1: the participants are provided with a printable patient education material of the same theme as the intervention group, but with low PEMAT scores.
Interventions/Control_3 Intervention 1: the participants are provided with an audiovisual patient education material with high PEMAT scores.
Interventions/Control_4 Control 2: the participants are provided with an audiovisual patient education material of the same theme as the intervention group, but with low PEMAT scores.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
69 years-old >=
Gender Male and Female
Key inclusion criteria Men and women between the ages of 18 and 69 years
Key exclusion criteria A person with clinical experience in health care, and with a history of disease or family history applicable to the material topic.
Target sample size 1576

Research contact person
Name of lead principal investigator
1st name Tsuyoshi
Middle name
Last name Okuhara
Organization School of Public Health, The University of Tokyo
Division name Department of Health Communication
Zip code 113-8655
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-5689-0726
Email okuhara-ctr@umin.ac.jp

Public contact
Name of contact person
1st name Emi
Middle name
Last name Furukawa
Organization School of Public Health, The University of Tokyo
Division name Department of Health Communication
Zip code 113-8655
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-5800-9754
Homepage URL
Email efurukawa-tho@umin.ac.jp

Sponsor
Institute University of Tokyo
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology (MEXT)
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 Office for Human Research Studies(OHRS) Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address Faculty of Medicine Bldg.2 4F 7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel 03-5841-0818
Email ethics@m.u-tokyo.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
2021 Year 01 Month 13 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 Preinitiation
Date of protocol fixation
2020 Year 02 Month 16 Day
Date of IRB
2020 Year 02 Month 26 Day
Anticipated trial start date
2021 Year 02 Month 01 Day
Last follow-up date
2021 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 01 Month 13 Day
Last modified on
2021 Year 01 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049080

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.