Unique ID issued by UMIN | UMIN000042989 |
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Receipt number | 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 | 2022/01/13 11:41:13 |
Evaluation of Understandability and Actionability of Patient Education Materials
Evaluation of Understandability and Actionability of Patient Education Materials
Translation, cross-cultural adaptation, and validation of the Japanese version of The Patient Education Materials Assessment Tool (PEMAT)
Translation, cross-cultural adaptation, and validation of the Japanese version of The Patient Education Materials Assessment Tool (PEMAT)
Japan |
Patient education materials
Not applicable | Adult |
Others
NO
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.
Efficacy
Confirmatory
Pragmatic
Not applicable
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.
Stages of behavioral change and perceived self-efficacy
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
4
Educational,Counseling,Training
Behavior,custom |
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.
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.
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.
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.
18 | years-old | <= |
79 | years-old | >= |
Male and Female
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.
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.
1576
1st name | Tsuyoshi |
Middle name | |
Last name | Okuhara |
School of Public Health, The University of Tokyo
Department of Health Communication
113-8655
7-3-1 Hongo, Bunkyo-ku, Tokyo
03-5689-0726
okuhara-ctr@umin.ac.jp
1st name | Emi |
Middle name | |
Last name | Furukawa |
School of Public Health, The University of Tokyo
Department of Health Communication
113-8655
7-3-1 Hongo, Bunkyo-ku, Tokyo
03-5800-9754
efurukawa-tho@umin.ac.jp
University of Tokyo
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Japanese Governmental office
Office for Human Research Studies(OHRS) Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Faculty of Medicine Bldg.2 4F 7-3-1 Hongo, Bunkyo-ku, Tokyo
03-5841-0818
ethics@m.u-tokyo.ac.jp
NO
2021 | Year | 01 | Month | 13 | Day |
Unpublished
1599
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.
2021 | Year | 07 | Month | 15 | Day |
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.
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.
No adverse events were reported.
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.
Completed
2020 | Year | 02 | Month | 16 | Day |
2020 | Year | 02 | Month | 26 | Day |
2021 | Year | 06 | Month | 20 | Day |
2021 | Year | 06 | Month | 25 | Day |
2021 | Year | 06 | Month | 30 | Day |
2021 | Year | 06 | Month | 30 | Day |
2021 | Year | 07 | Month | 31 | Day |
2021 | Year | 01 | Month | 13 | Day |
2022 | Year | 01 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049080
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