NCT02946567

Brief Summary

The investigators are studying the educational potential of games, with the goal of developing a game to improve learning and promote healthy hearing behaviors. The project is looking for adolescents and young adults that play games to share their experience and learning from playing games. The investigators ask participants to fill out an enrollment form/informed consent, complete surveys on healthy hearing habits, and play a game provided by the project. This projects aims the development and evaluation of a game to educate teenagers and young adults about noise-induced hearing loss, enhance knowledge about hearing, and promote healthy hearing behaviors with the potential to improve hearing health care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 27, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

October 5, 2017

Status Verified

October 1, 2017

Enrollment Period

6 months

First QC Date

October 24, 2016

Last Update Submit

October 3, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Knowledge, Attitudes, and Intended Behavior Questionnaire about hearing health care

    This instrument has been used to evaluate the effectiveness of past hearing loss prevention programs funded by the National Institute of Health. It contains questions on knowledge, attitudes, and intended behavior related to hearing health care. Although there are questions in different domains, the instrument consolidates the overall perception of participant on hearing health care.

    9 weeks

Study Arms (2)

Noisy City

EXPERIMENTAL

Participant will play the Noisy City game developed by this project.

Other: Noisy City information about hearing health care

Control

PLACEBO COMPARATOR

Participant will play a generic game.

Other: Generic Game

Interventions

Participants will play the game Noisy City, which contains information about hearing health care.

Noisy City

Participants will play a generic game without any particular information about hearing health care.

Control

Eligibility Criteria

Age13 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Participants have to be between the ages of 13 and 20 years of age (either gender).
  • Participants who are between the ages of 13 and 17 years of age must have a willing and able parent or legal guardian who permits them to participate.
  • Participants must have Internet access, an email address (or be able to use parent's/legal guardian's email address), and agree to play a game (random assignment to a group with a different game).

You may not qualify if:

  • Participants will be excluded if they are cognitively impaired, have any serious medical problem that may interfere with their ability to engage with the online game.
  • Those who are not able to read/follow written instructions and individuals with an excessive addiction to games will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Photozig, Inc.

Moffett Field, California, 94035-0128, United States

Location

Study Officials

  • Bruno Kajiyama, MS

    Photozig, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CEO

Study Record Dates

First Submitted

October 24, 2016

First Posted

October 27, 2016

Study Start

September 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

October 5, 2017

Record last verified: 2017-10

Locations