- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02045511
The Baltimore HEARS Pilot Study (HEARS)
The Baltimore HEARS Pilot Study: Hearing Health Care Equality Through Accessible Research & Solutions
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21215
- Weinberg Senior Living Communities
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 60 years or older
- English-speaking
- Aural-oral verbal communication as primary communication modality
- Post-lingual hearing loss
- Does not currently use a hearing amplification device or hearing aid
- Signed informed consent to participate in baseline, 1 month, and 3 month assessments
- Have a communication partner able to accompany them to all study-related appointments
Exclusion Criteria:
- Individuals who do not fulfill inclusion criteria
- Score ≤ 25 on the Montreal Cognitive Assessment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immediate Treatment Group
Immediate treatment with Baltimore HEARS intervention
|
Tailored fitting and programming of a personal sound amplifier.
This will be accompanied by a component of aural rehabilitation.
Tailored aural rehabilitation for participant and communication partner
|
Placebo Comparator: Delayed Treatment Group
3-month delayed treatment with Baltimore HEARS intervention
|
Tailored fitting and programming of a personal sound amplifier.
This will be accompanied by a component of aural rehabilitation.
Tailored aural rehabilitation for participant and communication partner
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE)-S at 3 Months
Time Frame: 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 |
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Revised QDS at 3 Months
Time Frame: 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. |
3 months
|
Change From Baseline in Revised UCLA at 3 Months
Time Frame: 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 |
3 months
|
Change From Baseline in PHQ-9 at 3 Months
Time Frame: 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. |
3 months
|
Change From Baseline in SF-36 Mental Component at 3 Months
Time Frame: 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]. |
3 months
|
Change From Baseline in SF-36 Physical Component at 3 Months
Time Frame: 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]. |
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Frank Lin, MD, PhD, Johns Hopkins University
Publications and helpful links
General Publications
- Stewart AL, Hays RD, Ware JE Jr. The MOS short-form general health survey. Reliability and validity in a patient population. Med Care. 1988 Jul;26(7):724-35. doi: 10.1097/00005650-198807000-00007. No abstract available.
- Russell D, Peplau LA, Cutrona CE. The revised UCLA Loneliness Scale: concurrent and discriminant validity evidence. J Pers Soc Psychol. 1980 Sep;39(3):472-80. doi: 10.1037//0022-3514.39.3.472.
- Ventry IM, Weinstein BE. Identification of elderly people with hearing problems. ASHA. 1983 Jul;25(7):37-42. No abstract available.
- Weinstein BE. Validity of a screening protocol for identifying elderly people with hearing problems. ASHA. 1986 May;28(5):41-5. No abstract available.
- Tuley MR, Mulrow CD, Aguilar C, Velez R. A critical reevaluation of the Quantified Denver Scale of Communication Function. Ear Hear. 1990 Feb;11(1):56-61. doi: 10.1097/00003446-199002000-00011.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA_00088278
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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