An interventional study of Baltimore HEARS and Baltimore HEARS in Age-related Hearing Impairment 1 and Personal Communication, sponsored by Johns Hopkins University. Completed at 2 sites in United States. Open to participants aged 60 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-04.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Other
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.
719 studies on the registry are indexed under Communication; 159 are open to participants now.
This study's enrollment of 151 is close to the median of 144 across 571 interventional studies indexed under Communication.
Browse Communication studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immediate treatment with Baltimore HEARS intervention
Behavioral: Baltimore HEARS · Device: Baltimore HEARS
3-month delayed treatment with Baltimore HEARS intervention
Behavioral: Baltimore HEARS · Device: Baltimore HEARS
Tailored aural rehabilitation for participant and communication partner (if applicable)
Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
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.
Time frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
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.
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)
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.
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
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.
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
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.
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
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.
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
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.
Time frame: 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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
Time frame: 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.
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 12 months post-intervention
Study recruitment began in April 2018 and ended in October 2019. Participants were recruited from independent senior housing in Baltimore City and County and from Baltimore City senior centers and social centers.
| Milestone | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Started | 78 | 73 |
| Completed | 73 | 70 |
| Not completed | 5 | 3 |
| Withdrew: Death | 3 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Obtained hearing aids | 0 | 1 |
| Milestone | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Started | 58 | 52 |
| Completed | 57 | 51 |
| Not completed | 1 | 1 |
| Withdrew: Incomplete measurement | 1 | 1 |
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.
| score on a scale | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S) | -13.2 ± 10.3 | .06 ± 7.1 |
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.
| score on a scale | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Change From Baseline in Revised UCLA Loneliness Scale | -2.8 ± 8.7 | -0.6 ± 7 |
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.
| score on a scale | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9) | -1 ± 4.3 | -0.2 ± 4 |
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.
| score on a scale | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Change From Baseline in Short Form-12 (SF-12) Mental Component Score | 1.1 ± 11.2 | -1.4 ± 10 |
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.
| score on a scale | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Change From Baseline in Short Form -12 (SF-12) Physical Component Score | 4.4 ± 10.4 | -0.4 ± 10.1 |
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.
| number of roles | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Change From Baseline in Cohen Social Network Index (SNI): Network Diversity | 0.3 ± 1.2 | -0.0 ± 1.2 |
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.
| number of individuals | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Change From Baseline in Cohen Social Network Index (SNI): Social Network Size | 1.8 ± 10.5 | 1.0 ± 7.2 |
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.
| score on a scale | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Change From Baseline in Valuation of Life | 0.1 ± 6.9 | -0.6 ± 5.1 |
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.
| score on a scale | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy | -0.5 ± 3.8 | 0 ± 3.2 |
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.
| score on a scale | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy | -0.6 ± 3.8 | -0.1 ± 3.6 |
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.
| score on a scale | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest | 0.7 ± 2.3 | -0.4 ± 2.5 |
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.
| score on a scale | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score | 10.8 ± 11.3 | -0.7 ± 8.1 |
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.
| score on a scale | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening | 5.1 ± 5.7 | -0.1 ± 4.3 |
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.
| score on a scale | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening | 4.2 ± 5.1 | -0.1 ± 4.5 |
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.
| score on a scale | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet | 1.5 ± 2.7 | -0.6 ± 2.8 |
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.
| score on a scale | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Change From Baseline in Hearing Knowledge | 0.2 ± 1.6 | -0.4 ± 1.5 |
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.
| score on a scale | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S) | -10.3 ± 11 | -8.2 ± 13.4 |
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.
| score on a scale | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Change From Baseline in Revised UCLA Loneliness Scale | -1.3 ± 6.8 | -1.9 ± 9.0 |
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.
| score on a scale | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9) | -0.3 ± 3.3 | -1.1 ± 4.5 |
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.
| score on a scale | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Change From Baseline in Short Form -12 (SF-12) Mental Component Score | 0.5 ± 9.9 | 0.7 ± 13.0 |
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.
| score on a scale | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Change From Baseline in Short Form -12 (SF-12) Physical Component Score | 1.0 ± 9.3 | 1.7 ± 11.4 |
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.
| contact roles | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Change From Baseline in Cohen (Social Network Index) SNI: Network Diversity | -0.1 ± 1.0 | -0.2 ± 1.3 |
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.
| individuals | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Change From Baseline in Cohen Social Network Index (SNI): Social Network Size | -1.5 ± 12.4 | -3.7 ± 10.4 |
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.
| score on a scale | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Change From Baseline in Valuation of Life | -1.9 ± 6.6 | -1.0 ± 7.6 |
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.
| score on a scale | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy | -0.6 ± 3.5 | -0.4 ± 3.0 |
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.
| score on a scale | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy | 0.3 ± 3.9 | 0.2 ± 2.9 |
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.
| score on a scale | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest | 0.9 ± 2.2 | 0.1 ± 2.0 |
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.
| score on a scale | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score | 8.3 ± 9.3 | 8.2 ± 10.7 |
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.
| score on a scale | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening | 4.0 ± 5.6 | 4.8 ± 5.3 |
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.
| score on a scale | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening | 2.8 ± 3.8 | 2.5 ± 4.5 |
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.
| score on a scale | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet | 1.5 ± 1.9 | 0.8 ± 2.8 |
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.
| score on a scale | Immediate Treatment Group | Delayed Treatment Group |
|---|---|---|
| Change From Baseline in Hearing Knowledge | 0.2 ± 1.7 | 0.0 ± 1.7 |
Collected over Adverse event data for each participant is collected from Screening to 12 Month Post-Intervention Visit (up to 2 years). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Immediate Treatment Group | 6/78 (7.7%) | 0/78 (0%) | 0/78 (0%) |
| Delayed Treatment Group | 4/73 (5.5%) | 0/73 (0%) | 0/73 (0%) |
| Age, Continuous(years) | Immediate Treatment Group | Delayed Treatment Group | Total |
|---|---|---|---|
| Mean | 76.1 ± 7.1 | 78.2 ± 8.8 | 77.1 ± 8 |
| Sex/Gender, Customized(Participants) | Immediate Treatment Group | Delayed Treatment Group | Total |
|---|---|---|---|
| Sex — Female | 47 | 54 | 101 |
| Sex — Male | 31 | 17 | 48 |
| Sex — NA | 0 | 2 | 2 |
| Race/Ethnicity, Customized(Participants) | Immediate Treatment Group | Delayed Treatment Group | Total |
|---|---|---|---|
| Race/Ethnicity — Black | 40 | 25 | 65 |
| Race/Ethnicity — Hispanic | 1 | 2 | 3 |
| Race/Ethnicity — White Not Hispanic | 37 | 39 | 76 |
| Race/Ethnicity — Other | 0 | 7 | 7 |
| Living Arrangement(Participants) | Immediate Treatment Group | Delayed Treatment Group | Total |
|---|---|---|---|
| Does not live alone | 25 | 17 | 42 |
| Lives Alone | 53 | 56 | 109 |
| Education(Participants) | Immediate Treatment Group | Delayed Treatment Group | Total |
|---|---|---|---|
| High School or Equivalent | 20 | 22 | 42 |
| Less than High School | 21 | 21 | 42 |
| More than High School | 37 | 30 | 67 |
| Monthly Household Income(Participants) | Immediate Treatment Group | Delayed Treatment Group | Total |
|---|---|---|---|
| Less than $25,000 | 48 | 48 | 96 |
| $25,000 to $49,999 | 16 | 16 | 32 |
| $50,000 to $74,999 | 7 | 4 | 11 |
| $75,000 to $99,999 | 2 | 2 | 4 |
| $100,000 to $149,999 | 0 | 1 | 1 |
| Don't Know | 3 | 1 | 4 |
| Refused | 2 | 0 | 2 |
| Skipped | 0 | 1 | 1 |
| Montreal Cognitive Assessment(score on a scale) | Immediate Treatment Group | Delayed Treatment Group | Total |
|---|---|---|---|
| Mean | 22.6 ± 4.4 | 23.5 ± 3.9 | 23 ± 4.2 |
| Speech-Frequency Pure Tone Average(db HL) | Immediate Treatment Group | Delayed Treatment Group | Total |
|---|---|---|---|
| Mean | 41.5 ± 12.8 | 42.6 ± 11.2 | 42 ± 12 |
21 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2018 to primary completion in Jun 2020, 25 months.
Results were first posted in Oct 2021, 1 year 3 months after primary completion.
Of 390 non-industry interventional studies with no phase under Communication, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's 25 months is above that.
Counting every sponsor, half of 394 studies reached it within 18 months; a quarter within 6 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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