UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042989
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

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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 or person

Institute

University of Tokyo

Institute

Department

Personal name



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

Value
https://center6.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