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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

151 participants

Primary outcome timeframe

Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)

Results posted on

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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-intervention

Population: 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

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-intervention

Population: 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

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-intervention

Population: 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

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-intervention

Population: 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

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-intervention

Population: 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

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-intervention

Population: 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

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-intervention

Population: 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

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-intervention

Population: 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

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-intervention

Population: 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

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-intervention

Population: 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

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-intervention

Population: 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

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-intervention

Population: 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

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-intervention

Population: 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

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-intervention

Population: 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

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-intervention

Population: 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

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-intervention

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 6 deaths

Delayed Treatment Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths

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

Phone: 410-502-6965

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place