HIL: Mechanisms of Health Literacy and Information Accessibility in the Deaf

Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT03093779
Collaborator
Rochester Institute of Technology (Other), Sinai Health System (Other), Hurley Medical Center (Other), Boston University (Other)
901
3
56.7
300.3
5.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Health Information Assessment

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 Design

Study Type:
Observational
Actual Enrollment :
901 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Mechanisms of Health Literacy and Information Accessibility in the Deaf
Actual Study Start Date :
Dec 9, 2016
Actual Primary Completion Date :
Aug 30, 2021
Actual Study Completion Date :
Aug 30, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Health Literacy [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mount Sinai Hospital Chicago Illinois United States 60608
2 Hurley Medical Center Flint Michigan United States 48503
3 Rochester Institute of Technology/National Technical Institute for the Deaf Rochester New York United States 14623

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Michael McKee, Assistant Professor of Family Medicine, University of Michigan
ClinicalTrials.gov Identifier:
NCT03093779
Other Study ID Numbers:
  • HUM00104423
First Posted:
Mar 28, 2017
Last Update Posted:
Oct 6, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Michael McKee, Assistant Professor of Family Medicine, University of Michigan
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2021