Mechanisms of Health Literacy and Information Accessibility in the Deaf (HIL)

September 28, 2021 updated by: Michael McKee, University of Michigan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

University of Michigan(UM) is the clinical coordinating center (CCC) and data coordinating center (DCC) for this study. There are no subject recruitment or interaction will take place at UM. CCC engages clinicians and the clinical research mission and provides the training and professional development to ensure effective study by recruiting and maintaining the study sites performed at the Hurley Medical Center at Flint, Michigan, The National Technical Institute of Technology(NTID) at Rochester Institute of Technology in Rochester, New York, and The Sinai Deaf Health(SDH)program in Chicago, Illinois including participates. Thus, educating and training investigators, study coordinators, and other research staff to ensure an ongoing quality improvement of research processes. DCC is highly invested in producing the highest quality survey questionnaires for use with deaf ASL-users and hearing, English speakers. The study team will only use the best possible ASL translations of the data collection measures in order to best obtain accurate, high-quality research.

University of Michigan (UM) will function as the lead site, not as a performance site. UM will oversee all three other sites and conduct quality checks with each site, assist with training of the staff for standardization, and conduct data management/storage of de-identified data along with analysis. Hard copies and identifiers will be maintained at each site as per their approved IRB protocols.

The two primary objectives of this proposal are:

  • To elucidate the role of information marginalization on health literacy in Deaf American Sign Language (ASL) users
  • To better understand the mechanisms of health literacy in this population so as to identify viable targets for future health literacy intervention development. This proposal is responsive to PAR-10-133's request for studies that assess mechanisms underlying health literacy, including roles of cognition, culture, language fluency, and information-seeking and interpretation ability in the deaf population and, how these may differ from the hearing population.

A secondary objective is to assess how varying levels of hearing loss can affect individuals' abilities to access and comprehend health information and their health literacy adequacy.

Study Type

Observational

Enrollment (Actual)

901

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60608
        • Mount Sinai Hospital
    • Michigan
      • Flint, Michigan, United States, 48503
        • Hurley Medical Center
    • New York
      • Rochester, New York, United States, 14623
        • Rochester Institute of Technology/National Technical Institute for the Deaf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

450 Deaf ASL users and 450 Hearing native English speakers

Description

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Deaf
Individuals who are deaf and use sign language to communicate.
Other: Health Information Assessment
Assess how hearing loss and health literacy alters the ability to access and comprehend online health information
Hearing
Individuals with no hearing loss and who communicate in spoken English.
Other: Health Information Assessment
Assess how hearing loss and health literacy alters the ability to access and comprehend online health information

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Literacy
Time Frame: 5 minutes in a single data assessment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

Boston University
Rochester Institute of Technology
Sinai Health System
Hurley Medical Center

Investigators

  • Principal Investigator: Michael McKee, MD, MPH, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2016

Primary Completion (Actual)

August 30, 2021

Study Completion (Actual)

August 30, 2021

Study Registration Dates

First Submitted

March 22, 2017

First Submitted That Met QC Criteria

March 22, 2017

First Posted (Actual)

March 28, 2017

Study Record Updates

Last Update Posted (Actual)

October 6, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00104423

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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