Trial Outcomes & Findings for Baltimore HEARS: Hearing Health Equity Through Accessible Research & Solutions (NCT NCT03442296)
NCT ID: NCT03442296
Last Updated: 2022-10-04
Results Overview
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.
COMPLETED
NA
151 participants
Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
2022-10-04
Participant Flow
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.
Participant milestones
| Measure |
Immediate Treatment Group
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
|---|---|---|
|
3 Month Follow-up
STARTED
|
78
|
73
|
|
3 Month Follow-up
COMPLETED
|
73
|
70
|
|
3 Month Follow-up
NOT COMPLETED
|
5
|
3
|
|
12 Month Follow-up
STARTED
|
58
|
52
|
|
12 Month Follow-up
COMPLETED
|
57
|
51
|
|
12 Month Follow-up
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Immediate Treatment Group
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
|---|---|---|
|
3 Month Follow-up
Death
|
3
|
1
|
|
3 Month Follow-up
Lost to Follow-up
|
1
|
1
|
|
3 Month Follow-up
Withdrawal by Subject
|
1
|
0
|
|
3 Month Follow-up
Obtained Hearing Aids
|
0
|
1
|
|
12 Month Follow-up
Incomplete measurement
|
1
|
1
|
Baseline Characteristics
1 survey missing from immediate group. 1 survey refused from immediate group
Baseline characteristics by cohort
| Measure |
Immediate Treatment Group
n=78 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
n=73 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
76.1 years
STANDARD_DEVIATION 7.1 • n=78 Participants
|
78.2 years
STANDARD_DEVIATION 8.8 • n=73 Participants
|
77.1 years
STANDARD_DEVIATION 8 • n=151 Participants
|
|
Sex/Gender, Customized
Sex · Female
|
47 Participants
n=78 Participants
|
54 Participants
n=73 Participants
|
101 Participants
n=151 Participants
|
|
Sex/Gender, Customized
Sex · Male
|
31 Participants
n=78 Participants
|
17 Participants
n=73 Participants
|
48 Participants
n=151 Participants
|
|
Sex/Gender, Customized
Sex · NA
|
0 Participants
n=78 Participants
|
2 Participants
n=73 Participants
|
2 Participants
n=151 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black
|
40 Participants
n=78 Participants
|
25 Participants
n=73 Participants
|
65 Participants
n=151 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
1 Participants
n=78 Participants
|
2 Participants
n=73 Participants
|
3 Participants
n=151 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White Not Hispanic
|
37 Participants
n=78 Participants
|
39 Participants
n=73 Participants
|
76 Participants
n=151 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
0 Participants
n=78 Participants
|
7 Participants
n=73 Participants
|
7 Participants
n=151 Participants
|
|
Living Arrangement
Does not live alone
|
25 Participants
n=78 Participants
|
17 Participants
n=73 Participants
|
42 Participants
n=151 Participants
|
|
Living Arrangement
Lives Alone
|
53 Participants
n=78 Participants
|
56 Participants
n=73 Participants
|
109 Participants
n=151 Participants
|
|
Education
High School or Equivalent
|
20 Participants
n=78 Participants
|
22 Participants
n=73 Participants
|
42 Participants
n=151 Participants
|
|
Education
Less than High School
|
21 Participants
n=78 Participants
|
21 Participants
n=73 Participants
|
42 Participants
n=151 Participants
|
|
Education
More than High School
|
37 Participants
n=78 Participants
|
30 Participants
n=73 Participants
|
67 Participants
n=151 Participants
|
|
Monthly Household Income
Less than $25,000
|
48 Participants
n=78 Participants
|
48 Participants
n=73 Participants
|
96 Participants
n=151 Participants
|
|
Monthly Household Income
$25,000 to $49,999
|
16 Participants
n=78 Participants
|
16 Participants
n=73 Participants
|
32 Participants
n=151 Participants
|
|
Monthly Household Income
$50,000 to $74,999
|
7 Participants
n=78 Participants
|
4 Participants
n=73 Participants
|
11 Participants
n=151 Participants
|
|
Monthly Household Income
$75,000 to $99,999
|
2 Participants
n=78 Participants
|
2 Participants
n=73 Participants
|
4 Participants
n=151 Participants
|
|
Monthly Household Income
$100,000 to $149,999
|
0 Participants
n=78 Participants
|
1 Participants
n=73 Participants
|
1 Participants
n=151 Participants
|
|
Monthly Household Income
Don't Know
|
3 Participants
n=78 Participants
|
1 Participants
n=73 Participants
|
4 Participants
n=151 Participants
|
|
Monthly Household Income
Refused
|
2 Participants
n=78 Participants
|
0 Participants
n=73 Participants
|
2 Participants
n=151 Participants
|
|
Monthly Household Income
Skipped
|
0 Participants
n=78 Participants
|
1 Participants
n=73 Participants
|
1 Participants
n=151 Participants
|
|
Montreal Cognitive Assessment
|
22.6 score on a scale
STANDARD_DEVIATION 4.4 • n=76 Participants • 1 survey missing from immediate group. 1 survey refused from immediate group
|
23.5 score on a scale
STANDARD_DEVIATION 3.9 • n=73 Participants • 1 survey missing from immediate group. 1 survey refused from immediate group
|
23 score on a scale
STANDARD_DEVIATION 4.2 • n=149 Participants • 1 survey missing from immediate group. 1 survey refused from immediate group
|
|
Speech-Frequency Pure Tone Average
|
41.5 db HL
STANDARD_DEVIATION 12.8 • n=78 Participants
|
42.6 db HL
STANDARD_DEVIATION 11.2 • n=73 Participants
|
42 db HL
STANDARD_DEVIATION 12 • n=151 Participants
|
|
Hearing Loss
Mild
|
43 Participants
n=78 Participants
|
35 Participants
n=73 Participants
|
78 Participants
n=151 Participants
|
|
Hearing Loss
Moderate to severe
|
35 Participants
n=78 Participants
|
38 Participants
n=73 Participants
|
73 Participants
n=151 Participants
|
|
Prior Hearing Aid Use
No prior Hearing Aid Use
|
66 Participants
n=78 Participants
|
52 Participants
n=73 Participants
|
118 Participants
n=151 Participants
|
|
Prior Hearing Aid Use
Prior Hearing Aid Use
|
11 Participants
n=78 Participants
|
21 Participants
n=73 Participants
|
32 Participants
n=151 Participants
|
|
Prior Hearing Aid Use
Don't Know
|
1 Participants
n=78 Participants
|
0 Participants
n=73 Participants
|
1 Participants
n=151 Participants
|
|
HHIE-S (Hearing handicap inventory for the elderly - screening)
|
21.7 score on a scale
STANDARD_DEVIATION 9.4 • n=76 Participants • 2 incomplete surveys from the immediate group
|
20.1 score on a scale
STANDARD_DEVIATION 10.1 • n=73 Participants • 2 incomplete surveys from the immediate group
|
21 score on a scale
STANDARD_DEVIATION 9.7 • n=149 Participants • 2 incomplete surveys from the immediate group
|
|
UCLA Loneliness Scale
|
23.3 score on a scale
STANDARD_DEVIATION 10 • n=75 Participants • 5 incomplete surveys not included (3 immediate, 2 delayed)
|
20.6 score on a scale
STANDARD_DEVIATION 9.2 • n=71 Participants • 5 incomplete surveys not included (3 immediate, 2 delayed)
|
22 score on a scale
STANDARD_DEVIATION 9.7 • n=146 Participants • 5 incomplete surveys not included (3 immediate, 2 delayed)
|
|
Patient Health Questionnaire - Depression Score (PHQ-9)
|
6 score on a scale
STANDARD_DEVIATION 4.5 • n=75 Participants • 8 incomplete surveys not included (3 immediate, 5 delayed)
|
5.9 score on a scale
STANDARD_DEVIATION 4.5 • n=68 Participants • 8 incomplete surveys not included (3 immediate, 5 delayed)
|
6 score on a scale
STANDARD_DEVIATION 4.5 • n=143 Participants • 8 incomplete surveys not included (3 immediate, 5 delayed)
|
|
Cohen Social Network Index (SNI): Network Diversity
|
4.8 number of roles
STANDARD_DEVIATION 1.9 • n=73 Participants • 8 incomplete measures not included (5 immediate, 3 delayed)
|
4.9 number of roles
STANDARD_DEVIATION 1.7 • n=70 Participants • 8 incomplete measures not included (5 immediate, 3 delayed)
|
4.8 number of roles
STANDARD_DEVIATION 1.8 • n=143 Participants • 8 incomplete measures not included (5 immediate, 3 delayed)
|
|
Cohen Social Network Index (SNI): Social Network Size
|
17 number of people
n=73 Participants • 8 incomplete measures not included (5 immediate, 3 delayed)
|
15.5 number of people
n=70 Participants • 8 incomplete measures not included (5 immediate, 3 delayed)
|
16 number of people
n=143 Participants • 8 incomplete measures not included (5 immediate, 3 delayed)
|
|
12-Item Short Form Survey (SF-12): Mental Component Score
|
48.5 score on a scale
STANDARD_DEVIATION 10.1 • n=75 Participants • 6 incomplete measures not included (3 immediate, 3 delayed)
|
49.4 score on a scale
STANDARD_DEVIATION 9.9 • n=70 Participants • 6 incomplete measures not included (3 immediate, 3 delayed)
|
49 score on a scale
STANDARD_DEVIATION 10 • n=145 Participants • 6 incomplete measures not included (3 immediate, 3 delayed)
|
|
12-Item Short Form Survey (SF-12) Physical Component Score
|
39 score on a scale
STANDARD_DEVIATION 11 • n=75 Participants • 6 incomplete measures not included (3 immediate, 3 delayed)
|
39.4 score on a scale
STANDARD_DEVIATION 11.1 • n=70 Participants • 6 incomplete measures not included (3 immediate, 3 delayed)
|
39.2 score on a scale
STANDARD_DEVIATION 11 • n=145 Participants • 6 incomplete measures not included (3 immediate, 3 delayed)
|
|
Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-SF)
|
6.1 score on a scale
STANDARD_DEVIATION 1.7 • n=77 Participants • 1 incomplete measure not included from immediate group
|
6.1 score on a scale
STANDARD_DEVIATION 1.8 • n=73 Participants • 1 incomplete measure not included from immediate group
|
6.1 score on a scale
STANDARD_DEVIATION 1.8 • n=150 Participants • 1 incomplete measure not included from immediate group
|
|
Adapted from Attitudes Towards Computers Questionnaire (ATCQ): Computer Self Efficacy
|
19.3 score on a scale
STANDARD_DEVIATION 3.9 • n=78 Participants
|
19.1 score on a scale
STANDARD_DEVIATION 4.6 • n=73 Participants
|
19.2 score on a scale
STANDARD_DEVIATION 4.3 • n=151 Participants
|
|
Adapted from Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest
|
13.9 units on a scale
STANDARD_DEVIATION 1.8 • n=78 Participants
|
14.3 units on a scale
STANDARD_DEVIATION 1.8 • n=73 Participants
|
14.1 units on a scale
STANDARD_DEVIATION 1.8 • n=151 Participants
|
|
Adapted from Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Self Efficacy
|
21.7 units on a scale
STANDARD_DEVIATION 2.3 • n=77 Participants • 3 incomplete measures not included (1 immedaite, 2 delayed)
|
20.9 units on a scale
STANDARD_DEVIATION 3.1 • n=71 Participants • 3 incomplete measures not included (1 immedaite, 2 delayed)
|
21.3 units on a scale
STANDARD_DEVIATION 2.7 • n=148 Participants • 3 incomplete measures not included (1 immedaite, 2 delayed)
|
|
Own Smartphone
Doesn't own smartphone
|
36 Participants
n=78 Participants
|
32 Participants
n=73 Participants
|
68 Participants
n=151 Participants
|
|
Own Smartphone
Owns smartphone
|
42 Participants
n=78 Participants
|
40 Participants
n=73 Participants
|
82 Participants
n=151 Participants
|
|
Own Smartphone
NA
|
0 Participants
n=78 Participants
|
1 Participants
n=73 Participants
|
1 Participants
n=151 Participants
|
|
Used Computer within past month
"I do not have or use a computer"
|
38 Participants
n=78 Participants
|
38 Participants
n=73 Participants
|
76 Participants
n=151 Participants
|
|
Used Computer within past month
"I have or use a computer but I do not go on the internet"
|
9 Participants
n=78 Participants
|
6 Participants
n=73 Participants
|
15 Participants
n=151 Participants
|
|
Used Computer within past month
"I have or use a computer and I used the internet"
|
31 Participants
n=78 Participants
|
29 Participants
n=73 Participants
|
60 Participants
n=151 Participants
|
|
Used text or email within the past month
Most days
|
27 Participants
n=78 Participants
|
24 Participants
n=73 Participants
|
51 Participants
n=151 Participants
|
|
Used text or email within the past month
Some days
|
8 Participants
n=78 Participants
|
13 Participants
n=73 Participants
|
21 Participants
n=151 Participants
|
|
Used text or email within the past month
Rarely
|
10 Participants
n=78 Participants
|
10 Participants
n=73 Participants
|
20 Participants
n=151 Participants
|
|
Used text or email within the past month
Not within the past month
|
33 Participants
n=78 Participants
|
26 Participants
n=73 Participants
|
59 Participants
n=151 Participants
|
|
Adapted from Listening Self-Efficacy Questionnaire (LSEQ): Total Score
|
28.9 score on a scale
STANDARD_DEVIATION 10.3 • n=78 Participants • 2 incomplete baseline measures in the delayed group
|
28.9 score on a scale
STANDARD_DEVIATION 9.1 • n=71 Participants • 2 incomplete baseline measures in the delayed group
|
28.9 score on a scale
STANDARD_DEVIATION 9.7 • n=149 Participants • 2 incomplete baseline measures in the delayed group
|
|
Adapted from Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening Self- Efficacy
|
7.7 score on a scale
STANDARD_DEVIATION 4.9 • n=78 Participants • 1 incomplete baseline measure in the delayed group
|
7.3 score on a scale
STANDARD_DEVIATION 4.7 • n=72 Participants • 1 incomplete baseline measure in the delayed group
|
7.6 score on a scale
STANDARD_DEVIATION 4.8 • n=150 Participants • 1 incomplete baseline measure in the delayed group
|
|
Adapted from Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening Self-Efficacy
|
13.7 score on a scale
STANDARD_DEVIATION 4.5 • n=78 Participants • 2 incomplete baseline measures in the delayed group
|
13.8 score on a scale
STANDARD_DEVIATION 4 • n=71 Participants • 2 incomplete baseline measures in the delayed group
|
13.8 score on a scale
STANDARD_DEVIATION 4.2 • n=149 Participants • 2 incomplete baseline measures in the delayed group
|
|
Adapted from Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet Listening Self-Efficacy
|
7.4 score on a scale
STANDARD_DEVIATION 2.5 • n=78 Participants • 1 incomplete baseline measure in delayed group
|
7.7 score on a scale
STANDARD_DEVIATION 2.2 • n=72 Participants • 1 incomplete baseline measure in delayed group
|
7.6 score on a scale
STANDARD_DEVIATION 2.4 • n=150 Participants • 1 incomplete baseline measure in delayed group
|
|
Hearing Knowledge
|
3.3 score on a scale
STANDARD_DEVIATION 1.5 • n=73 Participants • 9 incomplete baseline measures (5 immediate, 4 delayed)
|
3.4 score on a scale
STANDARD_DEVIATION 1.7 • n=69 Participants • 9 incomplete baseline measures (5 immediate, 4 delayed)
|
3.4 score on a scale
STANDARD_DEVIATION 1.6 • n=142 Participants • 9 incomplete baseline measures (5 immediate, 4 delayed)
|
PRIMARY outcome
Timeframe: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)Population: 4 incomplete baseline measures (2 immediate, 2 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 3 incomplete 3 month measures from immediate 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.
Outcome measures
| Measure |
Immediate Treatment Group
n=68 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
n=68 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: 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)
|
-13.2 score on a scale
Standard Deviation 10.3
|
.06 score on a scale
Standard Deviation 7.1
|
SECONDARY outcome
Timeframe: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)Population: 5 incomplete baseline measures (3 immediate, 2 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 16 incomplete 3 month measures (11 immediate, 5 delayed)
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.
Outcome measures
| Measure |
Immediate Treatment Group
n=59 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
n=63 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
|---|---|---|
|
Change From Baseline in Revised UCLA Loneliness Scale
|
-2.8 score on a scale
Standard Deviation 8.7
|
-0.6 score on a scale
Standard Deviation 7
|
SECONDARY outcome
Timeframe: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)Population: 8 incomplete baseline measures (3 immediate, 5 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 11 incomplete 3 month measures (9 immediate, 2 delayed)
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.
Outcome measures
| Measure |
Immediate Treatment Group
n=61 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
n=63 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
|---|---|---|
|
Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9)
|
-1 score on a scale
Standard Deviation 4.3
|
-0.2 score on a scale
Standard Deviation 4
|
SECONDARY outcome
Timeframe: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)Population: 6 incomplete baseline measures (3 immediate, 3 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 12 incomplete 3 month measures (11 immediate, 1 delayed)
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.
Outcome measures
| Measure |
Immediate Treatment Group
n=59 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
n=66 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
|---|---|---|
|
Change From Baseline in Short Form-12 (SF-12) Mental Component Score
|
1.1 score on a scale
Standard Deviation 11.2
|
-1.4 score on a scale
Standard Deviation 10
|
SECONDARY outcome
Timeframe: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)Population: 6 incomplete baseline measures (3 immediate, 3 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 12 incomplete 3 month measures (11 immediate, 1 delayed)
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.
Outcome measures
| Measure |
Immediate Treatment Group
n=59 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
n=66 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
|---|---|---|
|
Change From Baseline in Short Form -12 (SF-12) Physical Component Score
|
4.4 score on a scale
Standard Deviation 10.4
|
-0.4 score on a scale
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)Population: 5 incomplete measures at baseline (3 immediate, 2 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 17 incomplete 3 month measures (12 immediate, 5 delayed)
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.
Outcome measures
| Measure |
Immediate Treatment Group
n=58 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
n=63 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
|---|---|---|
|
Change From Baseline in Cohen Social Network Index (SNI): Network Diversity
|
0.3 number of roles
Standard Deviation 1.2
|
-0.0 number of roles
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)Population: 5 incomplete baseline measures (3 immediate, 2 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 17 incomplete 3 month measures (12 immediate, 5 delayed)
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.
Outcome measures
| Measure |
Immediate Treatment Group
n=58 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
n=63 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
|---|---|---|
|
Change From Baseline in Cohen Social Network Index (SNI): Social Network Size
|
1.8 number of individuals
Standard Deviation 10.5
|
1.0 number of individuals
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)Population: 7 incomplete baseline measures (3 immediate, 4 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 11 incomplete 3 month measures (10 immediate, 1 delayed)
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.
Outcome measures
| Measure |
Immediate Treatment Group
n=60 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
n=65 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
|---|---|---|
|
Change From Baseline in Valuation of Life
|
0.1 score on a scale
Standard Deviation 6.9
|
-0.6 score on a scale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)Population: 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 12 incomplete 3 month measures (11 immediate, 1 delayed)
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.
Outcome measures
| Measure |
Immediate Treatment Group
n=62 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
n=69 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
|---|---|---|
|
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy
|
-0.5 score on a scale
Standard Deviation 3.8
|
0 score on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)Population: 3 incomplete baseline measures (1 immediate, 2 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 10 incomplete 3 month measures from immediate group
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.
Outcome measures
| Measure |
Immediate Treatment Group
n=62 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
n=68 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
|---|---|---|
|
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy
|
-0.6 score on a scale
Standard Deviation 3.8
|
-0.1 score on a scale
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)Population: 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 10 incomplete 3 month measures in immediate group
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.
Outcome measures
| Measure |
Immediate Treatment Group
n=63 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
n=70 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
|---|---|---|
|
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest
|
0.7 score on a scale
Standard Deviation 2.3
|
-0.4 score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)Population: 2 incomplete baseline measures (2 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 12 incomplete 3 month measures (12 immediate)
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.
Outcome measures
| Measure |
Immediate Treatment Group
n=61 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
n=68 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
|---|---|---|
|
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score
|
10.8 score on a scale
Standard Deviation 11.3
|
-0.7 score on a scale
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)Population: 1 incomplete baseline measures (1 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 12 incomplete 3 month measures (12 immediate)
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.
Outcome measures
| Measure |
Immediate Treatment Group
n=61 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
n=69 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
|---|---|---|
|
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening
|
5.1 score on a scale
Standard Deviation 5.7
|
-0.1 score on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)Population: 2 incomplete baseline measures (2 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 12 incomplete 3 month measures (12 immediate)
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.
Outcome measures
| Measure |
Immediate Treatment Group
n=61 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
n=68 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
|---|---|---|
|
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening
|
4.2 score on a scale
Standard Deviation 5.1
|
-0.1 score on a scale
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)Population: 1 incomplete baseline measures (1 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 12 incomplete 3 month measures (12 immediate)
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.
Outcome measures
| Measure |
Immediate Treatment Group
n=61 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
n=69 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
|---|---|---|
|
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet
|
1.5 score on a scale
Standard Deviation 2.7
|
-0.6 score on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)Population: 9 incomplete baseline measures (5 immediate, 4 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 14 incomplete 3 month measures (12 immediate, 2 delayed)
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.
Outcome measures
| Measure |
Immediate Treatment Group
n=56 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
n=64 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
|---|---|---|
|
Change From Baseline in Hearing Knowledge
|
0.2 score on a scale
Standard Deviation 1.6
|
-0.4 score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline and 12 months post-interventionPopulation: 4 incomplete baseline measure (2 immediate, 2 delayed) 14 withdrew consent (4 immediate, 10 delayed) 6 non-study related deaths (3 immediate, 3 delayed) 13 lost to follow up (8 immediate, 5 delayed) 8 incomplete 12 month measures (6 immediate, 3 delayed)
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.
Outcome measures
| Measure |
Immediate Treatment Group
n=55 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
n=50 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: 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)
|
-10.3 score on a scale
Standard Deviation 11
|
-8.2 score on a scale
Standard Deviation 13.4
|
SECONDARY outcome
Timeframe: Baseline and 12 months post-interventionPopulation: 5 incomplete baseline measure (3 immediate, 2 delayed) 14 withdrew consent (4 immediate, 10 delayed) 6 non-study related deaths (3 immediate, 3 delayed) 13 lost to follow up (8 immediate, 5 delayed) 30 incomplete 12 month measures (19 immediate, 11 delayed)
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.
Outcome measures
| Measure |
Immediate Treatment Group
n=41 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
n=42 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
|---|---|---|
|
Change From Baseline in Revised UCLA Loneliness Scale
|
-1.3 score on a scale
Standard Deviation 6.8
|
-1.9 score on a scale
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: Baseline and 12 months post-interventionPopulation: 8 missing at baseline (3 immediate, 5 delayed) 14 withdrew consent (4 immediate, 10 delayed) 6 non-study related deaths (3 immediate, 3 delayed) 13 lost to follow up (8 immediate, 5 delayed) 22 Incomplete 12 month measures (8 immediate, 14 delayed)
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.
Outcome measures
| Measure |
Immediate Treatment Group
n=49 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
n=39 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
|---|---|---|
|
Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9)
|
-0.3 score on a scale
Standard Deviation 3.3
|
-1.1 score on a scale
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Baseline and 12 months post-interventionPopulation: 6 incomplete at baseline (3 immediate, 3 delayed) 14 withdrew consent (4 immediate, 10 delayed) 6 non-study related deaths (3 immediate, 3 delayed) 13 lost to follow up (8 immediate, 5 delayed) 27 incomplete 12 month measures (12 immediate, 15 delayed)
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.
Outcome measures
| Measure |
Immediate Treatment Group
n=48 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
n=37 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
|---|---|---|
|
Change From Baseline in Short Form -12 (SF-12) Mental Component Score
|
0.5 score on a scale
Standard Deviation 9.9
|
0.7 score on a scale
Standard Deviation 13.0
|
SECONDARY outcome
Timeframe: Baseline and 12 months post-interventionPopulation: 6 incomplete at baseline (3 immediate, 3 delayed) 14 withdrew consent (4 immediate, 10 delayed) 6 non-study related deaths (3 immediate, 3 delayed) 13 lost to follow up (8 immediate, 5 delayed) 27 incomplete 12 month measures (12 immediate, 15 delayed)
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.
Outcome measures
| Measure |
Immediate Treatment Group
n=48 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
n=37 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
|---|---|---|
|
Change From Baseline in Short Form -12 (SF-12) Physical Component Score
|
1.0 score on a scale
Standard Deviation 9.3
|
1.7 score on a scale
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: Baseline and 12 months post-interventionPopulation: 5 incomplete at baseline (3 immediate, 2 delayed) 14 withdrew consent (4 immediate, 10 delayed) 6 non-study related deaths (3 immediate, 3 delayed) 13 lost to follow up (8 immediate, 5 delayed) 27 incomplete 12 month measures (15 immediate, 12 delayed)
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.
Outcome measures
| Measure |
Immediate Treatment Group
n=45 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
n=41 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
|---|---|---|
|
Change From Baseline in Cohen (Social Network Index) SNI: Network Diversity
|
-0.1 contact roles
Standard Deviation 1.0
|
-0.2 contact roles
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Baseline and 12 months post-interventionPopulation: 5 incomplete at baseline (3 immediate, 2 delayed) 14 withdrew consent (4 immediate, 10 delayed) 6 non-study related deaths (3 immediate, 3 delayed) 13 lost to follow up (8 immediate, 5 delayed) 27 incomplete at 12 month (15 immediate, 12 delayed)
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.
Outcome measures
| Measure |
Immediate Treatment Group
n=45 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
n=41 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
|---|---|---|
|
Change From Baseline in Cohen Social Network Index (SNI): Social Network Size
|
-1.5 individuals
Standard Deviation 12.4
|
-3.7 individuals
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: Baseline and 12 months post-interventionPopulation: 7 incomplete baseline (3 immediate, 4 delayed) 14 withdrew consent (4 immediate, 10 delayed) 6 non-study related deaths (3 immediate, 3 delayed) 13 lost to follow up (8 immediate, 5 delayed) 25 incomplete 12 month measures (14 immediate, 11 delay)
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.
Outcome measures
| Measure |
Immediate Treatment Group
n=46 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
n=40 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
|---|---|---|
|
Change From Baseline in Valuation of Life
|
-1.9 score on a scale
Standard Deviation 6.6
|
-1.0 score on a scale
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: Baseline and 12 months post-interventionPopulation: 3 incomplete at baseline (1 immediate, 2 delayed) 14 withdrew consent (4 immediate, 10 delayed) 6 non-study related deaths (3 immediate, 3 delayed) 13 lost to follow up (8 immediate, 5 delayed) 28 incomplete 12 month measures (14 immediate, 14 delay)
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.
Outcome measures
| Measure |
Immediate Treatment Group
n=48 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
n=39 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
|---|---|---|
|
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy
|
-0.6 score on a scale
Standard Deviation 3.5
|
-0.4 score on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Baseline and 12 months post-interventionPopulation: 0 incomplete baseline (0 immediate, 0 delayed) 14 withdrew consent (4 immediate, 10 delayed) 6 non-study related deaths (3 immediate, 3 delayed) 13 lost to follow up (8 immediate, 5 delayed) 28 incomplete 12 month measures (14 immediate, 14 delayed)
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.
Outcome measures
| Measure |
Immediate Treatment Group
n=49 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
n=41 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
|---|---|---|
|
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy
|
0.3 score on a scale
Standard Deviation 3.9
|
0.2 score on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Baseline and 12 months post-interventionPopulation: 0 incomplete at baseline (0) 14 withdrew consent (4 immediate, 10 delayed) 6 non-study related deaths (3 immediate, 3 delayed) 13 lost to follow up (8 immediate, 5 delayed) 28 incomplete 12 month measures (14 immediate, 14 delayed)
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.
Outcome measures
| Measure |
Immediate Treatment Group
n=49 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
n=41 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
|---|---|---|
|
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest
|
0.9 score on a scale
Standard Deviation 2.2
|
0.1 score on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Baseline and 12 months post-interventionPopulation: 2 incomplete at baseline (0 immediate, 2 delayed) 14 withdrew consent (4 immediate, 10 delayed) 6 non-study related deaths (3 immediate, 3 delayed) 13 lost to follow up (8 immediate, 5 delayed) 28 incomplete 12 month measures (14 immediate, 14 delayed)
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.
Outcome measures
| Measure |
Immediate Treatment Group
n=49 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
n=39 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
|---|---|---|
|
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score
|
8.3 score on a scale
Standard Deviation 9.3
|
8.2 score on a scale
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: Baseline and 12 months post-interventionPopulation: 1 incomplete at baseline (0 immediate, 1 delayed) 14 withdrew consent (4 immediate, 10 delayed) 6 non-study related deaths (3 immediate, 3 delayed) 13 lost to follow up (8 immediate, 5 delayed) 28 incomplete 12 month measures (14 immediate, 14 delayed)
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.
Outcome measures
| Measure |
Immediate Treatment Group
n=49 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
n=40 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
|---|---|---|
|
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening
|
4.0 score on a scale
Standard Deviation 5.6
|
4.8 score on a scale
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: Baseline and 12 months post-interventionPopulation: 2 incomplete baseline measure (0 immediate, 2 delayed) 14 withdrew consent (4 immediate, 10 delayed) 6 non-study related deaths (3 immediate, 3 delayed) 13 lost to follow up (8 immediate, 5 delayed) 28 incomplete 12 month measures (14 immediate, 14 delayed)
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.
Outcome measures
| Measure |
Immediate Treatment Group
n=49 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
n=39 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
|---|---|---|
|
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening
|
2.8 score on a scale
Standard Deviation 3.8
|
2.5 score on a scale
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Baseline and 12 months post-interventionPopulation: 1 incomplete at baseline (0 immediate, 1 delayed) 14 withdrew consent (4 immediate, 10 delayed) 6 non-study related deaths (3 immediate, 3 delayed) 13 lost to follow up (8 immediate, 5 delayed) 29 incomplete 12 month measures (14 immediate, 15 delayed)
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.
Outcome measures
| Measure |
Immediate Treatment Group
n=49 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
n=39 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
|---|---|---|
|
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet
|
1.5 score on a scale
Standard Deviation 1.9
|
0.8 score on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Baseline and 12 months post-interventionPopulation: 9 incomplete at baseline (5 immediate, 4 delayed) 14 withdrew consent (4 immediate, 10 delayed) 6 non-study related deaths (3 immediate, 3 delayed) 13 lost to follow up (8 immediate, 5 delayed) 27 incomplete 12 month measures (12 immediate, 15 delayed)
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.
Outcome measures
| Measure |
Immediate Treatment Group
n=46 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Delayed Treatment Group
n=36 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
|---|---|---|
|
Change From Baseline in Hearing Knowledge
|
0.2 score on a scale
Standard Deviation 1.7
|
0.0 score on a scale
Standard Deviation 1.7
|
Adverse Events
Immediate Treatment Group
Delayed Treatment Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Carrie Nieman
Johns Hopkins University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place