Baltimore HEARS: Hearing Health Equity Through Accessible Research & Solutions (HEARS)
Primary Purpose
Age-related Hearing Impairment 1, Personal Communication
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Baltimore HEARS
Baltimore HEARS
Sponsored by
About this trial
This is an interventional other trial for Age-related Hearing Impairment 1
Eligibility Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- Individuals who do not fulfill inclusion criteria
- Evidence of ear disease or pathology requiring further medical evaluation
Sites / Locations
- Catholic Charities
- Weinberg Senior Living Communities
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Immediate Treatment Group
Delayed Treatment Group
Arm Description
Immediate treatment with Baltimore HEARS intervention
3-month delayed treatment with Baltimore HEARS intervention
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03442296
First Posted
February 6, 2018
Last Updated
September 6, 2022
Sponsor
Johns Hopkins University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
1. Study Identification
Unique Protocol Identification Number
NCT03442296
Brief Title
Baltimore HEARS: Hearing Health Equity Through Accessible Research & Solutions
Acronym
HEARS
Official Title
Baltimore HEARS Study: Addressing Hearing Impairment and Social Engagement Through Community-delivered Hearing Care
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 18, 2018 (Actual)
Primary Completion Date
June 17, 2020 (Actual)
Study Completion Date
July 14, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Hearing Impairment 1, Personal Communication
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate Treatment Group
Arm Type
Experimental
Arm Description
Immediate treatment with Baltimore HEARS intervention
Arm Title
Delayed Treatment Group
Arm Type
Placebo Comparator
Arm Description
3-month delayed treatment with Baltimore HEARS intervention
Intervention Type
Behavioral
Intervention Name(s)
Baltimore HEARS
Intervention Description
Tailored aural rehabilitation for participant and communication partner (if applicable)
Intervention Type
Device
Intervention Name(s)
Baltimore HEARS
Intervention Description
Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
Primary Outcome Measure Information:
Title
Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S)
Description
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)
Secondary Outcome Measure Information:
Title
Change From Baseline in Revised UCLA Loneliness Scale
Description
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)
Title
Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9)
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 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)
Title
Change From Baseline in Short Form-12 (SF-12) Mental Component Score
Description
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)
Title
Change From Baseline in Short Form -12 (SF-12) Physical Component Score
Description
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)
Title
Change From Baseline in Cohen Social Network Index (SNI): Network Diversity
Description
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)
Title
Change From Baseline in Cohen Social Network Index (SNI): Social Network Size
Description
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)
Title
Change From Baseline in Valuation of Life
Description
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)
Title
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy
Description
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)
Title
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy
Description
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)
Title
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest
Description
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)
Title
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score
Description
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)
Title
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening
Description
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)
Title
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening
Description
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)
Title
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet
Description
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)
Title
Change From Baseline in Hearing Knowledge
Description
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)
Title
Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S)
Description
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
Title
Change From Baseline in Revised UCLA Loneliness Scale
Description
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
Title
Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9)
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 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
Title
Change From Baseline in Short Form -12 (SF-12) Mental Component Score
Description
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
Title
Change From Baseline in Short Form -12 (SF-12) Physical Component Score
Description
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
Title
Change From Baseline in Cohen (Social Network Index) SNI: Network Diversity
Description
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
Title
Change From Baseline in Cohen Social Network Index (SNI): Social Network Size
Description
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
Title
Change From Baseline in Valuation of Life
Description
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
Title
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy
Description
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
Title
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy
Description
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
Title
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest
Description
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
Title
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score
Description
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
Title
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening
Description
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
Title
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening
Description
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
Title
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet
Description
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
Title
Change From Baseline in Hearing Knowledge
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
Individuals who do not fulfill inclusion criteria
Evidence of ear disease or pathology requiring further medical evaluation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank R Lin, MD, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carrie L Nieman, MD, MPH
Organizational Affiliation
Johns Hopkins University
Official's Role
Study Director
Facility Information:
Facility Name
Catholic Charities
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Weinberg Senior Living Communities
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
6626295
Citation
Ventry IM, Weinstein BE. Identification of elderly people with hearing problems. ASHA. 1983 Jul;25(7):37-42. No abstract available.
Results Reference
background
PubMed Identifier
3718608
Citation
Weinstein BE. Validity of a screening protocol for identifying elderly people with hearing problems. ASHA. 1986 May;28(5):41-5. No abstract available.
Results Reference
background
PubMed Identifier
2307305
Citation
Tuley 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.
Results Reference
background
PubMed Identifier
7431205
Citation
Russell 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.
Results Reference
background
PubMed Identifier
3393032
Citation
Stewart 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.
Results Reference
background
PubMed Identifier
35724253
Citation
Marrone 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.
Results Reference
derived
Links:
URL
https://consultgeri.org/try-this/general-assessment/issue-12
Description
Description of HHIE - S measure
Learn more about this trial
Baltimore HEARS: Hearing Health Equity Through Accessible Research & Solutions
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