Hearing LossHILNCT03093779
Mechanisms of Health Literacy and Information Accessibility in the Deaf
An observational study of Hearing Loss and Health Literacy, run by University of Michigan at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Health Literacy
- What is being tested?
- Health Information Assessment
- How many people
- 901 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Dec 2016to 30 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 450 Deaf ASL users and 450 Hearing native English speakers
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mount Sinai Hospital
Chicago, Illinois, 60608
Hurley Medical Center
Flint, Michigan, 48503
Rochester Institute of Technology/National Technical Institute for the Deaf
Rochester, New York, 14623
About this study
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.
Read the 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.
- Conditions
- Hearing Loss, Health Literacy
- Being tested
- Health Information Assessment
- Keywords
- Hearing Loss, Deaf, Health Literacy, Health Information, Visual Learning
- Medical subject headings
- Hearing Loss, Spatial Learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Information AssessmentOther
Assess how hearing loss and health literacy alters the ability to access and comprehend online health information
| Study group | Role | What they receive |
|---|---|---|
| Deaf | Individuals who are deaf and use sign language to communicate. Receives: Other: Health Information Assessment | |
| Hearing | Individuals with no hearing loss and who communicate in spoken English. Receives: Other: Health Information Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minutes in a single data assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start9 Dec 2016
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 901 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Rochester Institute of Technology, Sinai Health System, Hurley Medical Center, Boston University
- Responsible party
- Principal investigator, Michael McKee, University of Michigan
- Investigators
- Michael McKee, MD, MPH, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093779
- Sponsor's protocol ID
- HUM00104423
- Acronym
- HIL
- Status last verified
- Sep 2021
- First submitted
- 22 Mar 2017
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31599730Champlin 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.
PubMed 34491211Panko 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.
PubMed 34213997
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Health Literacy and Information Accessibility in the Deaf
- ClinicalTrials.gov ID
- NCT03093779
- Acronym / sponsor ID
- HIL / HUM00104423
- Conditions
- Hearing Loss, Health Literacy
- Keywords
- Hearing Loss, Deaf, Health Literacy, Health Information, Visual Learning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 901 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Rochester Institute of Technology, Sinai Health System, Hurley Medical Center, Boston University
- Study start
- 9 Dec 2016 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 28 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deaf | – | Other: Health Information AssessmentIndividuals who are deaf and use sign language to communicate. |
| Hearing | – | Other: Health Information AssessmentIndividuals with no hearing loss and who communicate in spoken English. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 450 Deaf ASL users and 450 Hearing native English speakers
Key inclusion criteria (4 listed)
- deaf persons who use sign language and live in Flint, Michigan, Rochester NY, and Chicago, IL metropolitan areas.
- hearing persons who speak fluent English and live in Flint, Michigan, Rochester NY, and Chicago, IL metropolitan areas.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Information AssessmentAssess how hearing loss and health literacy alters the ability to access and comprehend online health information | Other | Deaf, Hearing |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Background: PubMed 31599730McKee 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.
- Background: PubMed 34491211Champlin 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.
- Results publication: PubMed 34213997Panko 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael McKee, MD, MPH principal investigator
University of Michigan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss and Health Literacy, run by University of Michigan at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Literacy (time frame: 5 minutes in a single data assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03093779, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.