UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049067 |
|---|---|
| Receipt number | R000055891 |
| Scientific Title | Effects of app-based information provision on parents' health literacy and health service utilization: an open-label, non-randomized, parallel-controlled trial |
| Date of disclosure of the study information | 2022/09/29 |
| Last modified on | 2026/04/01 12:51:42 |
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Basic information
Public title
Effects of app-based information provision on parents' health literacy and health service utilization: an open-label, non-randomized, parallel-controlled trial
Acronym
Effects of app-based information provision on parents' health literacy and health service utilization
Scientific Title
Effects of app-based information provision on parents' health literacy and health service utilization: an open-label, non-randomized, parallel-controlled trial
Scientific Title:Acronym
Evaluation of the effect of the app in providing health information
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Access to appropriate health and medical information for parents contributes to appropriate health and medical examination behaviors for themselves and their children.
In recent years, the Internet is widely used, and app-based health education is increasing. However, there is little evidence that app-based education contributes to the improvement of parents' health literacy.
In this study, we evaluate whether the use of an app that provides medical information changes the health literacy and consultation behavior of parents.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Change in HLS-EU-Q47 Japanese scores 7 months after the introduction of the application
Key secondary outcomes
1.Change from baseline to 7 months after the introduction of the app in the number of ER visits on holidays and at night during the past 6 months of the time of survey.
2.uMARS(Mobile Application Rating Scale(user version) Scale score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Introduction of an application that provides children's health information
Interventions/Control_2
No referral to application for providing children's health information
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Parents of infants 18 years of age or older who received a 1.5 year health checkup at a health center in Nagano City (Seibu Health Center and Yoshida Health Center) between May and October 2022
2) Able to download the application on their smartphone
3) Written consent has been obtained regarding participation in the study.
Key exclusion criteria
(1) When the principal investigator considers him/her inappropriate to participate this research.
(2) When the accompanying person for the infant's medical checkup is other than the parents.
Target sample size
168
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Sakamoto |
Organization
Saku Central Hospital Advanced Care Center.
Division name
Department of Pediatrics
Zip code
385-0051
Address
3400-28 Nakagomi, Saku, Nagano, Japan
TEL
0267-62-8181
sakuteikyohealth@gmail.com
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Sakamoto |
Organization
Saku Central Hospital Advanced Care Center.
Division name
Department of Pediatrics
Zip code
385-0051
Address
3400-28 Nakagomi, Saku, Nagano, Japan
TEL
0267-62-8181
Homepage URL
sakuteikyohealth@gmail.com
Sponsor or person
Institute
Saku Central Hospital Advanced Care Center
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
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saku Central Hospital Group Research Ethics Committee
Address
197 Usuda, Saku, Nagano, Japan
Tel
0267-88-7821
irboffice@sakuhp.or.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
| 2022 | Year | 09 | Month | 29 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/40338704/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/40338704/
Number of participants that the trial has enrolled
200
Results
Parents' health literacy scores slightly improved in both groups, but the difference was not statistically significant. However, within the intervention group, higher app ratings were linked to greater health literacy gains. Additionally, those positive about future app use scored significantly higher on easily finding symptom information.
Results date posted
| 2026 | Year | 04 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 05 | Month | 09 | Day |
Baseline Characteristics
Demographics: Parents attending 1.5-year-old checkups in Nagano; mean age was 33.9 years, and 99% were mothers (female)
.
Parental Characteristics: 35% held a college degree or above, and 19% were health care workers
.
Participant flow
Allocation: A total of 303 participants were initially allocated (157 to the intervention group, 146 to the control group)
.
Baseline (Consented): After excluding 21 participants (declined or already using the app), 282 participants (142 intervention, 140 control) were included
.
Analyzed: Following 82 dropouts at the 7-month mark, 200 participants (100 per group) completed the follow-up and were analyzed
. In the intervention group, 71% successfully downloaded the app
.
Adverse events
none
Outcome measures
Primary Outcome: The change in the parents' health literacy scores (HLSs) between the baseline and the 7-month follow-up survey
.
Measurement Tool: Parental health literacy was measured using 16 questions from the health care domain of the Japanese version of the European Health Literacy Survey (HLS-EU-Q47)
. The index score was standardized to a unified metric ranging from 0 to 50, with a higher score indicating higher health literacy
.
Evaluation of the App (Intervention group only): Participants were evaluated on their expected frequency of future app use, the overall rating of the app, and the reassurance gained from using the app
.
Exploratory Post-hoc Analysis: The study investigated the associations between the app ratings, the expected future use of the app, and the changes in the parents' HLSs
.
Plan to share IPD
none
IPD sharing Plan description
none
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 29 | Day |
Last modified on
| 2026 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055891
