Trial Outcomes & Findings for The Baltimore HEARS Pilot Study (NCT NCT02045511)
NCT ID: NCT02045511
Last Updated: 2018-08-22
Results Overview
Mean change, Unpooled - comparing baseline to 3 month follow-up visit Measure Description: Measure was collected through a one-on-one interview with a trained data collector. Scoring: 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap
COMPLETED
NA
15 participants
3 months
2018-08-22
Participant Flow
Participant milestones
| Measure |
Immediate Treatment Group
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner
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
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
|
Overall Study
COMPLETED
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Baltimore HEARS Pilot Study
Baseline characteristics by cohort
| Measure |
Immediate Treatment Group
n=8 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner
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=7 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.9 years
n=5 Participants
|
72.2 years
n=7 Participants
|
70.1 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American or Other
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Hearing screening threshold
|
45.8 dB HL
n=5 Participants
|
31.7 dB HL
n=7 Participants
|
40 dB HL
n=5 Participants
|
|
HHIE-S (Hearing handicap inventory for the elderly - screening)
|
19 units on a scale
n=5 Participants
|
20 units on a scale
n=7 Participants
|
20 units on a scale
n=5 Participants
|
|
Revised Quantified Denver Scale of Communication Function (QDS)
|
16 units on a scale
n=5 Participants
|
16 units on a scale
n=7 Participants
|
16 units on a scale
n=5 Participants
|
|
Revised University of California Los Angeles (UCLA) Loneliness Scale
|
46 units on a scale
n=5 Participants
|
46 units on a scale
n=7 Participants
|
46 units on a scale
n=5 Participants
|
|
Patient Health Questionnaire (PHQ)
|
9.5 units on a scale
n=5 Participants
|
8 units on a scale
n=7 Participants
|
8 units on a scale
n=5 Participants
|
|
Short Form - 36 (SF) -36 mental component (Quality of Life)
|
50.9 units on a scale
n=5 Participants
|
56.6 units on a scale
n=7 Participants
|
54.4 units on a scale
n=5 Participants
|
|
SF-36 physical component (Quality of Life)
|
41.5 units on a scale
n=5 Participants
|
50.6 units on a scale
n=7 Participants
|
46.3 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsMean change, Unpooled - comparing baseline to 3 month follow-up visit Measure Description: Measure was collected through a one-on-one interview with a trained data collector. Scoring: 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap
Outcome measures
| Measure |
Immediate Treatment Group
n=8 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner
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=7 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner
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 at 3 Months
|
-8.5 units on a scale
Standard Deviation 15.4
|
0.3 units on a scale
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: 3 monthsMean change, Unpooled - comparing baseline to 3 month follow-up visit \[1\] Measure Description: Measure was collected through a one-on-one interview conducted by a trained data collector. Survey includes 5 questions, scored Strongly disagree, Slightly disagree, neither, slightly agree, or strongly agree (1, 2, 3, 4, 5) Scoring is from 1 (worst) to 5 (best). Scores were summed across each of the 5 survey questions resulting in a total range of 5 (worst) to 25 (best) Although utilized in multiple studies, including Yueh et al., 2001, there are no numerical anchors for what would represent a clinically important difference.
Outcome measures
| Measure |
Immediate Treatment Group
n=8 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner
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=7 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner
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 QDS at 3 Months
|
-5.9 units on a scale
Standard Deviation 6.8
|
-2.1 units on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: 3 monthsMean change, Unpooled - comparing baseline to 3 month follow-up visit \[1\] Measure Description: Measure was collected via a one-on-one interview conducted by a trained data collector. 20-item Likert-type scale. Total score is sum of the 20 items, scores range from 20 to 80. Lower values equate to lower levels of loneliness and higher values equate to higher levels of loneliness. Perry et al., 1990 uses the following 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
Outcome measures
| Measure |
Immediate Treatment Group
n=8 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner
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=7 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner
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 at 3 Months
|
-2.1 units on a scale
Standard Deviation 10.8
|
-4 units on a scale
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: 3 monthsMean change, Unpooled - comparing baseline to 3 month follow-up visit \[1\] Measure Description: Measure collected via one-on-one interview conducted by trained data collectors. Total of 9 questions, scored from 0 to 3. The score from each question are summed to a total score, which can range from 0 to 27. Interpretation of Total Score Total Score Depression Severity 0 No depression 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression. Change from baseline to 3 months was reported. An increase in the score from baseline to three months (a positive number) indicates a worsening in depression severity. A decrease in the score from baseline to three months (a negative number) indicates a reduction in depression severity.
Outcome measures
| Measure |
Immediate Treatment Group
n=8 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner
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=7 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner
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 PHQ-9 at 3 Months
|
-4.4 units on a scale
Standard Deviation 6.4
|
-1 units on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: 3 monthsMean change, Unpooled - comparing baseline to 3 month follow-up visit Data were collected via one-on-one interviews with trained data collectors. Standard scoring can be found at http://www.rand.org/health/surveys\_tools/mos/36-item-short-form/scoring.html. Higher scores indicate better mental health functioning; U.S. population norm: M = 50.0, SD = 10.0, range = \[2-74\].
Outcome measures
| Measure |
Immediate Treatment Group
n=8 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner
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=7 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner
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 SF-36 Mental Component at 3 Months
|
2.1 units on a scale
Standard Deviation 14.7
|
1.7 units on a scale
Standard Deviation 14
|
SECONDARY outcome
Timeframe: 3 monthsMean change, Unpooled - comparing baseline to 3 month follow-up visit Measure collected via one-on-one interview conducted by trained data collectors. Standard scoring can be found at http://www.rand.org/health/surveys\_tools/mos/36-item-short-form/scoring.html. Higher scores indicate better physical health functioning; U.S. population norm: M = 50, SD = 9.95, range = \[4-71\].
Outcome measures
| Measure |
Immediate Treatment Group
n=8 Participants
Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner
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=7 Participants
3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner
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 SF-36 Physical Component at 3 Months
|
3.6 units on a scale
Standard Deviation 5.8
|
-1.3 units on a scale
Standard Deviation 5.4
|
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
Carrie Nieman
Johns Hopkins University School of Medicine Dept. Otolaryngology-HNS
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place