Age-related Hearing Impairment 1HEARSNCT02045511
The Baltimore HEARS Pilot Study
A study testing Baltimore HEARS in people with Age-related Hearing Impairment 1 and Personal Communication, run by Johns Hopkins University at 1 site in United States.
Trial summary
The primary purpose of the study is to develop and test the preliminary efficacy of a first-in-kind community-based intervention to provide affordable, accessible and effective hearing health care to low-income, minority older adults. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-related Hearing Impairment 1, Personal Communication
- What is being tested?
- Baltimore HEARS
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 60 years or older
- English-speaking
- Aural-oral verbal communication as primary communication modality
- Post-lingual hearing loss
- Does not currently use a hearing amplification device or hearing aid
- Signed informed consent to participate in baseline, 1 month, and 3 month assessments
- Have a communication partner able to accompany them to all study-related appointments
Who cannot join
- Individuals who do not fulfill inclusion criteria
- Score ≤ 25 on the Montreal Cognitive Assessment
Trial locations and contacts
1 site in 1 country.
United States1 site
Weinberg Senior Living Communities
Baltimore, Maryland, 21215
About this study
Official title: The Baltimore HEARS Pilot Study: Hearing Health Care Equality Through Accessible Research & Solutions
The primary purpose of the study is to develop and test the preliminary efficacy of a first-in-kind community-based intervention to provide affordable, accessible and effective hearing health care to low-income, minority older adults.
Read the detailed description
Age-related hearing impairment is strongly associated with poorer communicative functioning and social isolation, but hearing impairment often goes undiagnosed and untreated, particularly among minority and low-income older adults. Novel interventions that translate research on social engagement, minority health, and hearing technology are needed to expand delivery of hearing health care to underserved older adults. The Baltimore Hearing Equality through Accessible Research and Solutions (HEARS) project will develop and pilot a first-in-kind community-based intervention to provide affordable, accessible, and effective hearing health care to minority and low-income older adults and their communication partners. The study will follow a mixed-methods approach that will incorporate quantitative and qualitative components throughout the formative and evaluative processes. Participants and their communication partners will be randomized to an immediate treatment group or a 3-month delayed treatment group. The investigators hypothesize that the intervention is associated with increased social engagement and communication, improved quality of life, and decreased loneliness and third-party disability in the immediate treatment compared to the delayed treatment group.
- Being tested
- Baltimore HEARS
- Medical subject headings
- Age-Related Hearing Impairment 1, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baltimore HEARSBehavioural
Tailored aural rehabilitation for participant and communication partner
Baltimore HEARSDevice
Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Treatment Group | Experimental | Immediate treatment with Baltimore HEARS intervention Receives: Behavioral: Baltimore HEARS; Device: Baltimore HEARS |
| Delayed Treatment Group | Placebo comparator | 3-month delayed treatment with Baltimore HEARS intervention Receives: Behavioral: Baltimore HEARS; Device: Baltimore HEARS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE)-S at 3 Months
Mean change, Unpooled - comparing baseline to 3 month follow-up visit
Measure Description: Measure was collected through a one-on-one interview with a trained data collector.
Scoring:
0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap
Measured: 3 months
Secondary outcomes (5)
Change From Baseline in Revised QDS at 3 Months
Mean change, Unpooled - comparing baseline to 3 month follow-up visit
[1] Measure Description: Measure was collected through a one-on-one interview conducted by a trained data collector.
Survey includes 5 questions, scored Strongly disagree, Slightly disagree, neither, slightly agree, or strongly agree (1, 2, 3, 4, 5)
Scoring is from 1 (worst) to 5 (best). Scores were summed across each of the 5 survey questions resulting in a total range of 5 (worst) to 25 (best)
Although utilized in multiple studies, including Yueh et al., 2001, there are no numerical anchors for what would represent a clinically important difference.
Measured: 3 months
Change From Baseline in Revised UCLA at 3 Months
Mean change, Unpooled - comparing baseline to 3 month follow-up visit
[1] Measure Description: Measure was collected via a one-on-one interview conducted by a trained data collector.
20-item Likert-type scale. Total score is sum of the 20 items, scores range from 20 to 80. Lower values equate to lower levels of loneliness and higher values equate to higher levels of loneliness.
Perry et al., 1990 uses the following score ranges:
20-34 - Low degree of loneliness 35-49 - Moderate degree of loneliness 50-64 - Moderately high degree of loneliness 65-80 - High degree of loneliness
Measured: 3 months
Change From Baseline in PHQ-9 at 3 Months
Mean change, Unpooled - comparing baseline to 3 month follow-up visit
[1] Measure Description: Measure collected via one-on-one interview conducted by trained data collectors.
Total of 9 questions, scored from 0 to 3. The score from each question are summed to a total score, which can range from 0 to 27.
Interpretation of Total Score Total Score Depression Severity 0 No depression 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression.
Change from baseline to 3 months was reported. An increase in the score from baseline to three months (a positive number) indicates a worsening in depression severity. A decrease in the score from baseline to three months (a negative number) indicates a reduction in depression severity.
Measured: 3 months
Change From Baseline in SF-36 Mental Component at 3 Months
Mean change, Unpooled - comparing baseline to 3 month follow-up visit
Data were collected via one-on-one interviews with trained data collectors.
Standard scoring can be found at http://www.rand.org/health/surveys_tools/mos/36-item-short-form/scoring.html.
Higher scores indicate better mental health functioning; U.S. population norm: M = 50.0, SD = 10.0, range = [2-74].
Measured: 3 months
Change From Baseline in SF-36 Physical Component at 3 Months
Mean change, Unpooled - comparing baseline to 3 month follow-up visit
Measure collected via one-on-one interview conducted by trained data collectors.
Standard scoring can be found at http://www.rand.org/health/surveys_tools/mos/36-item-short-form/scoring.html.
Higher scores indicate better physical health functioning; U.S. population norm: M = 50, SD = 9.95, range = [4-71].
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Age-related Hearing Impairment 1Studies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Otolaryngology-Head and Neck Surgery Foundation
- Responsible party
- Sponsor
- Investigators
- Frank Lin, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045511
- Sponsor's protocol ID
- NA_00088278
- Acronym
- HEARS
- Status last verified
- Aug 2018
- First submitted
- 22 Jan 2014
- Last updated
- 22 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ventry IM, Weinstein BE. Identification of elderly people with hearing problems. ASHA. 1983 Jul;25(7):37-42. No abstract available.
PubMed 6626295Weinstein BE. Validity of a screening protocol for identifying elderly people with hearing problems. ASHA. 1986 May;28(5):41-5. No abstract available.
PubMed 3718608Tuley MR, Mulrow CD, Aguilar C, Velez R. A critical reevaluation of the Quantified Denver Scale of Communication Function. Ear Hear. 1990 Feb;11(1):56-61. doi: 10.1097/00003446-199002000-00011.
PubMed 2307305Russell D, Peplau LA, Cutrona CE. The revised UCLA Loneliness Scale: concurrent and discriminant validity evidence. J Pers Soc Psychol. 1980 Sep;39(3):472-80. doi: 10.1037//0022-3514.39.3.472.
PubMed 7431205Stewart AL, Hays RD, Ware JE Jr. The MOS short-form general health survey. Reliability and validity in a patient population. Med Care. 1988 Jul;26(7):724-35. doi: 10.1097/00005650-198807000-00007. No abstract available.
PubMed 3393032
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Baltimore HEARS Pilot Study: Hearing Health Care Equality Through Accessible Research & Solutions
- ClinicalTrials.gov ID
- NCT02045511
- Acronym / sponsor ID
- HEARS / NA_00088278
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- American Academy of Otolaryngology-Head and Neck Surgery Foundation
- Study start
- Feb 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 27 Jan 2014 (estimated)
- Results
- Posted 6 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of the study is to develop and test the preliminary efficacy of a first-in-kind community-based intervention to provide affordable, accessible and effective hearing health care to low-income, minority older adults.
Detailed description
Age-related hearing impairment is strongly associated with poorer communicative functioning and social isolation, but hearing impairment often goes undiagnosed and untreated, particularly among minority and low-income older adults. Novel interventions that translate research on social engagement, minority health, and hearing technology are needed to expand delivery of hearing health care to underserved older adults. The Baltimore Hearing Equality through Accessible Research and Solutions (HEARS) project will develop and pilot a first-in-kind community-based intervention to provide affordable, accessible, and effective hearing health care to minority and low-income older adults and their communication partners. The study will follow a mixed-methods approach that will incorporate quantitative and qualitative components throughout the formative and evaluative processes. Participants and their communication partners will be randomized to an immediate treatment group or a 3-month delayed treatment group. The investigators hypothesize that the intervention is associated with increased social engagement and communication, improved quality of life, and decreased loneliness and third-party disability in the immediate treatment compared to the delayed treatment group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Treatment Group | Experimental | Behavioral: Baltimore HEARS, Device: Baltimore HEARSImmediate treatment with Baltimore HEARS intervention |
| Delayed Treatment Group | Placebo comparator | Behavioral: Baltimore HEARS, Device: Baltimore HEARS3-month delayed treatment with Baltimore HEARS intervention |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 60 years or older
- English-speaking
- Aural-oral verbal communication as primary communication modality
- Post-lingual hearing loss
- Does not currently use a hearing amplification device or hearing aid
Key exclusion criteria (2 listed)
- Individuals who do not fulfill inclusion criteria
- Score ≤ 25 on the Montreal Cognitive Assessment
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 |
|---|---|---|
| Baltimore HEARSTailored aural rehabilitation for participant and communication partner | Behavioural | Delayed Treatment Group, Immediate Treatment Group |
| Baltimore HEARSTailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation. | Device | Delayed Treatment Group, Immediate Treatment Group |
Primary outcome
Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE)-S at 3 Months
Time frame: 3 months
Mean change, Unpooled - comparing baseline to 3 month follow-up visit Measure Description: Measure was collected through a one-on-one interview with a trained data collector. Scoring: 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap
5 secondary outcomes
Change From Baseline in Revised QDS at 3 Months
Time frame: 3 months
Change From Baseline in Revised UCLA at 3 Months
Time frame: 3 months
Change From Baseline in PHQ-9 at 3 Months
Time frame: 3 months
Change From Baseline in SF-36 Mental Component at 3 Months
Time frame: 3 months
Change From Baseline in SF-36 Physical Component at 3 Months
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 6626295Ventry IM, Weinstein BE. Identification of elderly people with hearing problems. ASHA. 1983 Jul;25(7):37-42. No abstract available.
- Background: PubMed 3718608Weinstein BE. Validity of a screening protocol for identifying elderly people with hearing problems. ASHA. 1986 May;28(5):41-5. No abstract available.
- Background: PubMed 2307305Tuley MR, Mulrow CD, Aguilar C, Velez R. A critical reevaluation of the Quantified Denver Scale of Communication Function. Ear Hear. 1990 Feb;11(1):56-61. doi: 10.1097/00003446-199002000-00011.
- Background: PubMed 7431205Russell D, Peplau LA, Cutrona CE. The revised UCLA Loneliness Scale: concurrent and discriminant validity evidence. J Pers Soc Psychol. 1980 Sep;39(3):472-80. doi: 10.1037//0022-3514.39.3.472.
- Background: PubMed 3393032Stewart AL, Hays RD, Ware JE Jr. The MOS short-form general health survey. Reliability and validity in a patient population. Med Care. 1988 Jul;26(7):724-35. doi: 10.1097/00005650-198807000-00007. No abstract available.
- Description of HHIE - S measureLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Age-related Hearing Impairment 1
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HEARS Maryland: Extending Capacity for Affordable, Accessible Hearing Care Through Older Adult Peer Mentorship
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Enrolling by invitation
Hearing Health Equity Through Accessible Research and Solutions for Korean Americans
Age-related Hearing Impairment, Personal Communication
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.
Frank Lin, MD, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baltimore HEARS in people with Age-related Hearing Impairment 1 and Personal Communication, run by Johns Hopkins University at 1 site 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 7 inclusion and 2 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 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 6 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE)-S at 3 Months (time frame: 3 months). 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 NCT02045511, which also lists 5 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 22 Aug 2018; AzTrials last refreshed its copy on 27 Oct 2026.