UMIN-CTR Clinical Trial

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: After viewing the material, the participants rated the understandability and actionability of the material using a ten-point Likert scale from 1 to 10. The participants scored the items as 1 if they completely disagreed with the content of the item (if the material was understandable/actionable) and 10 if they completely agreed with it.
Key secondary outcomes	Stages of behavioral change and perceived self-efficacy

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 group for validation of PEMAT-P: the participants are provided with printable patient education material with high PEMAT scores. We used leaflets that promote healthy eating habits.
Interventions/Control_2	Control group for validation of PEMAT-P: the participants are provided with a printable patient education material of the same theme as the intervention group, but with low PEMAT scores. We used leaflets that promote healthy eating habits.
Interventions/Control_3	Intervention group for validation of PEMAT-A/V: the participants are provided with audiovisual patient education material with high PEMAT scores. We used videos themed on locomotive syndrome prevention for the elderly.
Interventions/Control_4	Control group for validation of PEMAT-A/V: the participants are provided with audiovisual patient education material of the same theme as the intervention group, but with low PEMAT scores. We used videos themed on locomotive syndrome prevention for the elderly.
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	79 years-old >=
Gender	Male and Female
Key inclusion criteria	The eligibility criteria for the participants were men and women who use Japanese as a native language. In the PEMAT-P, participants aged 18 to 69 years were included, and in the PEMAT-A/V, participants aged 60 to 79 years were included.
Key exclusion criteria	Participants were excluded if they had experience in health care; were restricted from practicing the action recommended in the materials due to illness or injury.
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	1599
Results	The intervention group had significantly higher scores for understandability and actionability than the control group Perceived self-efficacy was higher in the intervention group than in the control group.
Results date posted	2021 Year 07 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	In the PEMAT-P, 60% were male, the mean age was 46 years, and half had a college degree or higher. Baseline health literacy (HLS-14) was 53 on a 70-point scale.　In the PEMAT-A/V, 78% were male, the mean age was 66 years, and half had a college degree or higher. Baseline health literacy (HLS-14) was 52 on a 70-point scale.
Participant flow	For PEMAT-P, of 1,526 participants randomized, 400 in the intervention group and 399 in the control group generated data. For the PEMAT-A/V, of 1,211 participants randomized, 400 in the intervention group and 400 in the control group generated data.
Adverse events	No adverse events were reported.
Outcome measures	1. Understandability and actionability of the materials (each of 10 items, in 10 point-Likert scales) 2. Perceived self-efficacy for the actions recommended by the materials. Self-efficacy was measured by the Self-Efficacy Scale for Positive Eating Behavior in PEMAT-P and the Home-Exercise Barrier Self-Efficacy Scale in PEMAT-A/V.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
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 06 Month 20 Day
Last follow-up date	2021 Year 06 Month 25 Day
Date of closure to data entry	2021 Year 06 Month 30 Day
Date trial data considered complete	2021 Year 06 Month 30 Day
Date analysis concluded	2021 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date	2021 Year 01 Month 13 Day
Last modified on	2022 Year 01 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049080