NCT03093779

Brief Summary

The purpose of this proposal is to examine the attitudes, knowledge, and skills related to health information that influence health literacy among Deaf individuals.The study team will also examine frequently overlooked potential predictors of health literacy, including cognitive abilities, resilience, and self-efficacy. To achieve the study objectives, researchers will conduct an explanatory sequential mixed methods design using extensive quantitative data collection procedures, namely, cross-sectional surveys and measures that will identify predictors and moderators of health literacy with Deaf and hearing subjects. These results will inform the subsequent qualitative assessment using elicitation interviews that will help explain the quantitative results, and elucidate how and why Deaf individuals access and understand health information. A community advisory board consisting of Deaf community members will provide oversight to the proposal that will be led by multiple Deaf investigators, including the PI. The Deaf community, due to communication barriers, relative social marginalization, and their reliance on visual learning, provides a unique insight into how health information is distributed and disseminated visually. Findings may be applicable to other individuals with hearing loss who navigate and cope with life more visually than the typical hearing person. This will be critical to determine more accurately the effect of visual learning and existing online health information on health literacy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
901

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 9, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 28, 2017

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

October 6, 2021

Status Verified

September 1, 2021

Enrollment Period

4.7 years

First QC Date

March 22, 2017

Last Update Submit

September 28, 2021

Conditions

Keywords

Hearing LossDeafHealth LiteracyHealth InformationVisual Learning

Outcome Measures

Primary Outcomes (1)

  • Health Literacy

    Use of the American Sign Language- Newest Vital Sign and the English version of the Newest Vital Sign will be used to assess health literacy. Scores range from 0-6 with 5-6 considered to be adequate health literacy.

    5 minutes in a single data assessment

Study Arms (2)

Deaf

Individuals who are deaf and use sign language to communicate.

Other: Health Information Assessment

Hearing

Individuals with no hearing loss and who communicate in spoken English.

Other: Health Information Assessment

Interventions

Assess how hearing loss and health literacy alters the ability to access and comprehend online health information

DeafHearing

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

450 Deaf ASL users and 450 Hearing native English speakers

You may qualify if:

  • Deaf American Sign Language Users:
  • \- deaf persons who use sign language and live in Flint, Michigan, Rochester NY, and Chicago, IL metropolitan areas.
  • Hearing, English speakers:
  • \- hearing persons who speak fluent English and live in Flint, Michigan, Rochester NY, and Chicago, IL metropolitan areas.

You may not qualify if:

  • Those who have cognitive impairment (e.g., due to dementia, delirium or intoxication).
  • Those who unable to consent to the study.
  • Individuals with limited vision will be excluded if they are unable to effectively use a PC (i.e., function vision at 20-200 or worse).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mount Sinai Hospital

Chicago, Illinois, 60608, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

Rochester Institute of Technology/National Technical Institute for the Deaf

Rochester, New York, 14623, United States

Location

Related Publications (3)

  • McKee MM, Hauser PC, Champlin S, Paasche-Orlow M, Wyse K, Cuculick J, Buis LR, Plegue M, Sen A, Fetters MD. Deaf Adults' Health Literacy and Access to Health Information: Protocol for a Multicenter Mixed Methods Study. JMIR Res Protoc. 2019 Oct 9;8(10):e14889. doi: 10.2196/14889.

    PMID: 31599730BACKGROUND
  • Champlin S, Cuculick J, Hauser PC, Wyse K, McKee MM. Using Gaze Tracking as a Research Tool in the Deaf Health Literacy and Access to Health Information Project: Protocol for a Multisite Mixed Methods Study and Preliminary Results. JMIR Res Protoc. 2021 Sep 7;10(9):e26708. doi: 10.2196/26708.

    PMID: 34491211BACKGROUND
  • Panko TL, Contreras J, Postl D, Mussallem A, Champlin S, Paasche-Orlow MK, Hill J, Plegue MA, Hauser PC, McKee M. The Deaf Community's Experiences Navigating COVID-19 Pandemic Information. Health Lit Res Pract. 2021 Apr;5(2):e162-e170. doi: 10.3928/24748307-20210503-01. Epub 2021 Jun 22.

MeSH Terms

Conditions

Hearing LossSpatial Learning

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSpatial BehaviorBehavior

Study Officials

  • Michael McKee, MD, MPH

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Family Medicine

Study Record Dates

First Submitted

March 22, 2017

First Posted

March 28, 2017

Study Start

December 9, 2016

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

October 6, 2021

Record last verified: 2021-09

Locations