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The Baltimore HEARS Pilot Study (HEARS)

Primary Purpose

Age-related Hearing Impairment 1, Personal Communication

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Baltimore HEARS
Baltimore HEARS
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Age-related Hearing Impairment 1

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Weinberg Senior Living Communities

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Immediate Treatment Group

Delayed Treatment Group

Arm Description

Immediate treatment with Baltimore HEARS intervention

3-month delayed treatment with Baltimore HEARS intervention

Outcomes

Primary Outcome Measures

Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE)-S at 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

Secondary Outcome Measures

Change From Baseline in Revised QDS at 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.
Change From Baseline in Revised UCLA at 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
Change From Baseline in PHQ-9 at 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.
Change From Baseline in SF-36 Mental Component at 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].
Change From Baseline in SF-36 Physical Component at 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].

Full Information

First Posted
January 22, 2014
Last Updated
August 20, 2018
Sponsor
Johns Hopkins University
Collaborators
American Academy of Otolaryngology-Head and Neck Surgery Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02045511
Brief Title
The Baltimore HEARS Pilot Study
Acronym
HEARS
Official Title
The Baltimore HEARS Pilot Study: Hearing Health Care Equality Through Accessible Research & Solutions
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
American Academy of Otolaryngology-Head and Neck Surgery Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary purpose of the study is to develop and test the preliminary efficacy of a first-in-kind community-based intervention to provide affordable, accessible and effective hearing health care to low-income, minority older adults.
Detailed Description
Age-related hearing impairment is strongly associated with poorer communicative functioning and social isolation, but hearing impairment often goes undiagnosed and untreated, particularly among minority and low-income older adults. Novel interventions that translate research on social engagement, minority health, and hearing technology are needed to expand delivery of hearing health care to underserved older adults. The Baltimore Hearing Equality through Accessible Research and Solutions (HEARS) project will develop and pilot a first-in-kind community-based intervention to provide affordable, accessible, and effective hearing health care to minority and low-income older adults and their communication partners. The study will follow a mixed-methods approach that will incorporate quantitative and qualitative components throughout the formative and evaluative processes. Participants and their communication partners will be randomized to an immediate treatment group or a 3-month delayed treatment group. The investigators hypothesize that the intervention is associated with increased social engagement and communication, improved quality of life, and decreased loneliness and third-party disability in the immediate treatment compared to the delayed treatment group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Hearing Impairment 1, Personal Communication

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate Treatment Group
Arm Type
Experimental
Arm Description
Immediate treatment with Baltimore HEARS intervention
Arm Title
Delayed Treatment Group
Arm Type
Placebo Comparator
Arm Description
3-month delayed treatment with Baltimore HEARS intervention
Intervention Type
Behavioral
Intervention Name(s)
Baltimore HEARS
Intervention Description
Tailored aural rehabilitation for participant and communication partner
Intervention Type
Device
Intervention Name(s)
Baltimore HEARS
Intervention Description
Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
Primary Outcome Measure Information:
Title
Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE)-S at 3 Months
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change From Baseline in Revised QDS at 3 Months
Description
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.
Time Frame
3 months
Title
Change From Baseline in Revised UCLA at 3 Months
Description
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
Time Frame
3 months
Title
Change From Baseline in PHQ-9 at 3 Months
Description
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.
Time Frame
3 months
Title
Change From Baseline in SF-36 Mental Component at 3 Months
Description
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].
Time Frame
3 months
Title
Change From Baseline in SF-36 Physical Component at 3 Months
Description
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].
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Lin, MD, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weinberg Senior Living Communities
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
6626295
Citation
Ventry IM, Weinstein BE. Identification of elderly people with hearing problems. ASHA. 1983 Jul;25(7):37-42. No abstract available.
Results Reference
background
PubMed Identifier
3718608
Citation
Weinstein BE. Validity of a screening protocol for identifying elderly people with hearing problems. ASHA. 1986 May;28(5):41-5. No abstract available.
Results Reference
background
PubMed Identifier
2307305
Citation
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.
Results Reference
background
PubMed Identifier
7431205
Citation
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.
Results Reference
background
PubMed Identifier
3393032
Citation
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.
Results Reference
background
Links:
URL
https://consultgeri.org/try-this/general-assessment/issue-12
Description
Description of HHIE - S measure

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The Baltimore HEARS Pilot Study

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