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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

3 months

Results posted on

2018-08-22

Participant Flow

Participant milestones

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

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 months

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

Outcome measures

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 months

Mean 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

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 months

Mean 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

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 months

Mean 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

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 months

Mean 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

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 months

Mean 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

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

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

Delayed Treatment Group

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

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

Phone: 3025368362

Results disclosure agreements

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