Age-related Hearing Impairment 1HEARSNCT03442296
Baltimore HEARS: Hearing Health Equity Through Accessible Research & Solutions
A study testing Baltimore HEARS in people with Age-related Hearing Impairment 1 and Personal Communication, run by Johns Hopkins University at 2 sites in United States.
Trial summary
Age-related hearing loss is highly prevalent and hearing health care is underutilized. The primary objective of the proposed randomized controlled trial is to investigate the efficacy of a community health worker (CHW)-delivered hearing loss intervention program. Read more about this study
- Who is it for?
- Ages 60 to 100 yearsHealthy 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
- 151 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Apr 2018to 14 Jul 2021
- 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 to 100 years
- 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 (Audiometric pure tone averages [0.5-4kHz] in both ears >25 dB)
- Does not currently use a hearing amplification device or hearing aid
- Signed informed consent to participate in all study related activities
Show all 9Show fewer
- Willing to regularly use listening device once provided for the remainder of their time in the study
- Hearing handicap as measured by HHIE-S score >8
- Able to follow study instructions
Who cannot join
- Individuals who do not fulfill inclusion criteria
- Evidence of ear disease or pathology requiring further medical evaluation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Catholic Charities
Baltimore, Maryland, 21201
Weinberg Senior Living Communities
Baltimore, Maryland, 21215
About this study
Official title: Baltimore HEARS Study: Addressing Hearing Impairment and Social Engagement Through Community-delivered Hearing Care
Age-related hearing loss is highly prevalent and hearing health care is underutilized. The primary objective of the proposed randomized controlled trial is to investigate the efficacy of a community health worker (CHW)-delivered hearing loss intervention program. A preceding pilot study demonstrated preliminary effectiveness of the intervention program in reducing self-reported hearing handicap, and highlighted its acceptability among the target demographic. The proposed trial will now expand upon lessons learned through previous pilot studies and expand to other affordable residences for low-to-moderate income older adults in Baltimore. Primary outcome measurements will investigate intervention effects on hearing handicap, with secondary measurements investigating effects on domains such as social isolation and quality of life. This trial is a first-in-kind investigation of a novel community-based intervention that addresses hearing loss in a vulnerable, urban population.
- 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 (if applicable)
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)
Measure was collected through a one-on-one interview with a trained data collector. Higher scores indicate increased hearing handicap.
Scoring:
0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap
Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in hearing handicap.
Measured: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Secondary outcomes (31)
Change From Baseline in Revised UCLA Loneliness Scale
Measure was collected via a one-on-one interview conducted by a trained data collector.
Score is the sum of 20-item self-reported measure. Scores range from 20 to 80.
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.
Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in degree of loneliness.
Measured: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9)
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 is reported. An increase in the score from baseline (a positive number) indicates a worsening in depression severity.
Measured: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Short Form-12 (SF-12) Mental Component Score
The 12-Item Short Form Survey (SF-12) was collected through a one-on-one interview with a trained data collector.
The 12-Item Short Form Survey (SF-12) measures the construct of self-reported health-related quality of life. Here we report the mental component which relates to mental health functioning. Score ranges from 0-100 with higher scores indicating better mental health functioning.
Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a better health state.
Measured: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Short Form -12 (SF-12) Physical Component Score
The 12-Item Short Form Survey (SF-12) was collected through a one-on-one interview with a trained data collector.
The 12-Item Short Form Survey (SF-12) measures the construct of self-reported health-related quality of life. Here we report the physical component which relates to physical health functioning. Score ranges from 0-100 with higher scores indicating better physical health functioning.
Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a better health state.
Measured: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Cohen Social Network Index (SNI): Network Diversity
Change from baseline in total number of high contact roles the participant interacts with at least every 2 weeks (such as family, friends, work). Maximum of 12 roles included on the measure. An increase in the score from baseline (a positive number) indicates a more diverse network.
Measured: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Cohen Social Network Index (SNI): Social Network Size
Change from baseline in total number of individuals in high contact roles the participant interacts with at least every 2 weeks (such as family, friends, work). .An increase in the number of individuals from baseline (a positive number) indicates an increase in their social network size.
Measured: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Valuation of Life
This self-reported 13 question measure asks the participant how much they agree or disagree on a 5 point Likert scale when asked a statement about the meaning of life and personal goals. Score ranges from 0 to 65. Higher score means higher value of life.
Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher value of life.
Measured: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy
A 5 question measure surveying self-reported self-efficacy of computer use on a 5 point Likert scale. Score ranges from 0 to 25.
Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Measured: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy
A 5 question measure surveying self-reported device self-efficacy on a 5 point Likert scale. Score ranges from 0 to 25.
Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Measured: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest
A 5 question measure surveying self-reported self-efficacy of listening device interest on a 5 point Likert scale. Score ranges from 0 to 25.
Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Measured: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score
This 5 question survey measures listening self efficacy on a 0-10 scale in different situations such as being able to understand a conversation in a quiet room to a crowded restaurant. Participants answer with a higher number the more confident they are in the presented situation. Maximum possible score is 50.
Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Measured: Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening
This measure is the combined score of two questions where a participant self-reported their listening self efficacy on a 0-10 scale in complex listening situations. Participants answer with a higher number the more confident they are in the presented situation. Score ranges from 0 to 20.
Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Measured: Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening
This measure is the combined score of two questions where a participant self-reported their listening self efficacy on a 0-10 scale in complex listening situations. Participants answer with a higher number the more confident they are in the presented situation. Score ranges from 0 to 20.
Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Measured: Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet
This measure is a participant's self-reported listening self efficacy on a 0-10 score scale in a dialog in quiet listening situation. Participants answer with a higher number the more confident they are in the presented situation. Maximum possible score is 10.
Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Measured: Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)
Change From Baseline in Hearing Knowledge
This 5 question measure asks participants about their hearing knowledge based on the information presented in the intervention. The score ranges from 0 to 5.
Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates more hearing knowledge.
Measured: Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)
Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S)
Measure was collected through a one-on-one interview with a trained data collector. Higher scores indicate increased hearing handicap.
Scoring:
0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap.
Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in hearing handicap.
Measured: Baseline and 12 months post-intervention
Change From Baseline in Revised UCLA Loneliness Scale
Measure was collected via a one-on-one interview conducted by a trained data collector.
Score is the sum of 20-item self-reported measure. Scores range from 20 to 80.
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.
Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in degree of loneliness.
Measured: Baseline and 12 months post-intervention
Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9)
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 is reported. An increase in the score from baseline (a positive number) indicates a worsening in depression severity.
Measured: Baseline and 12 months post-intervention
Change From Baseline in Short Form -12 (SF-12) Mental Component Score
The 12-Item Short Form Survey (SF-12) was collected through a one-on-one interview with a trained data collector.
The 12-Item Short Form Survey (SF-12) measures the construct of self-reported health-related quality of life. Here we report the mental component which relates to mental health functioning. Score ranges from 0-100 with higher scores indicating better mental health functioning.
Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a better health state.
Measured: Baseline and 12 months post-intervention
Change From Baseline in Short Form -12 (SF-12) Physical Component Score
The 12-Item Short Form Survey (SF-12) was collected through a one-on-one interview with a trained data collector.
The 12-Item Short Form Survey (SF-12) measures the construct of self-reported health-related quality of life. Here we report the physical component which relates to physical health functioning. Score ranges from 0-100 with higher scores indicating better physical health functioning.
Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a better health state.
Measured: Baseline and 12 months post-intervention
Change From Baseline in Cohen (Social Network Index) SNI: Network Diversity
Change from baseline in total number of high contact roles the participant interacts with at least every 2 weeks (such as family, friends, work). Maximum of 12 roles included on the measure. An increase in the number of roles from baseline (a positive number) indicates a more diverse network.
Measured: Baseline and 12 months post-intervention
Change From Baseline in Cohen Social Network Index (SNI): Social Network Size
Change from baseline in total number of individuals in high contact roles the participant interacts with at least every 2 weeks (such as family, friends, work). .An increase in the number of individuals from baseline (a positive number) indicates an increase in their social network size.
Measured: Baseline and 12 months post-intervention
Change From Baseline in Valuation of Life
This self-reported 13 question measure asks the participant how much they agree or disagree on a 5 point Likert scale when asked a statement about the meaning of life and personal goals. Score ranges from 0 to 65. Higher score means higher value of life.
Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher value of life.
Measured: Baseline and 12 months post-intervention
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy
A 5 question measure surveying self-reported device self-efficacy on a 5 point Likert scale. Score ranges from 0 to 25.
Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Measured: Baseline and 12 months post-intervention
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy
A 5 question measure surveying self-reported self-efficacy of computer use on a 5 point Likert scale. Score ranges from 0 to 25.
Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Measured: Baseline and 12 months post-intervention
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest
A 5 question measure surveying self-reported self-efficacy of listening device interest on a 5 point Likert scale. Score ranges from 0 to 25.
Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Measured: Baseline and 12 months post-intervention
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score
This 5 question survey measures listening self efficacy on a 0-10 scale in different situations such as being able to understand a conversation in a quiet room to a crowded restaurant. Participants answer with a higher number the more confident they are in the presented situation. Maximum possible score is 50.
Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Measured: Baseline and 12 months post-intervention
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening
This measure is the combined score of two questions where a participant self-reported their listening self efficacy on a 0-10 scale in complex listening situations. Participants answer with a higher number the more confident they are in the presented situation. Score ranges from 0 to 20.
Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Measured: Baseline and 12 months post-intervention
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening
This measure is the combined score of two questions where a participant self-reported their listening self efficacy on a 0-10 scale in directed listening situations. Participants answer with a higher number the more confident they are in the presented situation. Score ranges from 0 to 20.
Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Measured: Baseline and 12 months post-intervention
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet
This measure is a participant's self-reported listening self efficacy on a 0-10 scale in a directed listening situation. Participants answer with a higher number the more confident they are in the presented situation. Maximum possible score is 10.
Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Measured: Baseline and 12 months post-intervention
Change From Baseline in Hearing Knowledge
This 5 question measure asks participants about their hearing knowledge based on the information presented in the intervention. Score ranges from 0 to 5.
Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates more hearing knowledge.
Measured: Baseline and 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start18 Apr 2018
- Primary completion17 Jun 2020
- Study completion14 Jul 2021
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 (7)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
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Frank R Lin, MD, PhD, Principal investigator, Johns Hopkins UniversityCarrie L Nieman, MD, MPH, Study director, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442296
- Sponsor's protocol ID
- IRB00144968
- Other IDs
- R33DC015062-03
- Acronym
- HEARS
- Status last verified
- Sep 2022
- First submitted
- 6 Feb 2018
- Last updated
- 4 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- 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 3393032Nieman CL, Betz J, Garcia Morales EE, Suen JJ, Trumbo J, Marrone N, Han HR, Szanton SL, Lin FR. Effect of a Community Health Worker-Delivered Personal Sound Amplification Device on Self-Perceived Communication Function in Older Adults With Hearing Loss: A Randomized Clinical Trial. JAMA. 2022 Dec 20;328(23):2324-2333. doi: 10.1001/jama.2022.21820.
PubMed 36538311Marrone NL, Nieman CL, Coco L. Community-Based Participatory Research and Human-Centered Design Principles to Advance Hearing Health Equity. Ear Hear. 2022 Jul-Aug 01;43(Suppl 1):33S-44S. doi: 10.1097/AUD.0000000000001183. Epub 2020 Jun 13.
PubMed 35724253
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baltimore HEARS Study: Addressing Hearing Impairment and Social Engagement Through Community-delivered Hearing Care
- ClinicalTrials.gov ID
- NCT03442296
- Acronym / sponsor ID
- HEARS / IRB00144968
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 17 Jun 2020 (actual)
- Study completion
- 14 Jul 2021 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Posted 14 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Age-related hearing loss is highly prevalent and hearing health care is underutilized. The primary objective of the proposed randomized controlled trial is to investigate the efficacy of a community health worker (CHW)-delivered hearing loss intervention program. A preceding pilot study demonstrated preliminary effectiveness of the intervention program in reducing self-reported hearing handicap, and highlighted its acceptability among the target demographic. The proposed trial will now expand upon lessons learned through previous pilot studies and expand to other affordable residences for low-to-moderate income older adults in Baltimore. Primary outcome measurements will investigate intervention effects on hearing handicap, with secondary measurements investigating effects on domains such as social isolation and quality of life. This trial is a first-in-kind investigation of a novel community-based intervention that addresses hearing loss in a vulnerable, urban population.
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 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 60 years or older
- English-speaking
- Aural-oral verbal communication as primary communication modality
- Post-lingual hearing loss (Audiometric pure tone averages [0.5-4kHz] in both ears >25 dB)
- Does not currently use a hearing amplification device or hearing aid
Key exclusion criteria (2 listed)
- Individuals who do not fulfill inclusion criteria
- Evidence of ear disease or pathology requiring further medical evaluation
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 (if applicable) | 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)
Time frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Measure was collected through a one-on-one interview with a trained data collector. Higher scores indicate increased hearing handicap. Scoring: 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in hearing handicap.
31 secondary outcomes
Change From Baseline in Revised UCLA Loneliness Scale
Time frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9)
Time frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Short Form-12 (SF-12) Mental Component Score
Time frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Short Form -12 (SF-12) Physical Component Score
Time frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Cohen Social Network Index (SNI): Network Diversity
Time frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Cohen Social Network Index (SNI): Social Network Size
Time frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Valuation of Life
Time frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy
Time frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy
Time frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest
Time frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score
Time frame: Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening
Time frame: Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening
Time frame: Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet
Time frame: Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)
Change From Baseline in Hearing Knowledge
Time frame: Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)
Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S)
Time frame: Baseline and 12 months post-intervention
Change From Baseline in Revised UCLA Loneliness Scale
Time frame: Baseline and 12 months post-intervention
Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9)
Time frame: Baseline and 12 months post-intervention
Change From Baseline in Short Form -12 (SF-12) Mental Component Score
Time frame: Baseline and 12 months post-intervention
Change From Baseline in Short Form -12 (SF-12) Physical Component Score
Time frame: Baseline and 12 months post-intervention
Change From Baseline in Cohen (Social Network Index) SNI: Network Diversity
Time frame: Baseline and 12 months post-intervention
Change From Baseline in Cohen Social Network Index (SNI): Social Network Size
Time frame: Baseline and 12 months post-intervention
Change From Baseline in Valuation of Life
Time frame: Baseline and 12 months post-intervention
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy
Time frame: Baseline and 12 months post-intervention
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy
Time frame: Baseline and 12 months post-intervention
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest
Time frame: Baseline and 12 months post-intervention
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score
Time frame: Baseline and 12 months post-intervention
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening
Time frame: Baseline and 12 months post-intervention
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening
Time frame: Baseline and 12 months post-intervention
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet
Time frame: Baseline and 12 months post-intervention
Change From Baseline in Hearing Knowledge
Time frame: Baseline and 12 months post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- 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.
- Derived from this study: PubMed 36538311Nieman CL, Betz J, Garcia Morales EE, Suen JJ, Trumbo J, Marrone N, Han HR, Szanton SL, Lin FR. Effect of a Community Health Worker-Delivered Personal Sound Amplification Device on Self-Perceived Communication Function in Older Adults With Hearing Loss: A Randomized Clinical Trial. JAMA. 2022 Dec 20;328(23):2324-2333. doi: 10.1001/jama.2022.21820.
- Derived from this study: PubMed 35724253Marrone NL, Nieman CL, Coco L. Community-Based Participatory Research and Human-Centered Design Principles to Advance Hearing Health Equity. Ear Hear. 2022 Jul-Aug 01;43(Suppl 1):33S-44S. doi: 10.1097/AUD.0000000000001183. Epub 2020 Jun 13.
- Description of HHIE - S measureLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Frank R Lin, MD, PhD principal investigator
Johns Hopkins University
Carrie L Nieman, MD, MPH study director
Johns Hopkins University
2 sites 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 2 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 9 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 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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 14 Oct 2021). 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) (time frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)). 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 NCT03442296, which also lists 7 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 4 Oct 2022; AzTrials last refreshed its copy on 2 Nov 2026.