NCT02045511

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2014

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
2 years until next milestone

Results Posted

Study results publicly available

September 6, 2017

Completed
Last Updated

August 22, 2018

Status Verified

August 1, 2018

Enrollment Period

1.6 years

First QC Date

January 22, 2014

Results QC Date

April 17, 2017

Last Update Submit

August 20, 2018

Conditions

Age-related Hearing Impairment 1Personal Communication

Outcome Measures

Primary Outcomes (1)

  • 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

    3 months

Secondary Outcomes (5)

  • Change From Baseline in Revised QDS at 3 Months

    3 months

  • Change From Baseline in Revised UCLA at 3 Months

    3 months

  • Change From Baseline in PHQ-9 at 3 Months

    3 months

  • Change From Baseline in SF-36 Mental Component at 3 Months

    3 months

  • Change From Baseline in SF-36 Physical Component at 3 Months

    3 months

Study Arms (2)

Immediate Treatment Group

EXPERIMENTAL

Immediate treatment with Baltimore HEARS intervention

Behavioral: Baltimore HEARSDevice: Baltimore HEARS

Delayed Treatment Group

PLACEBO COMPARATOR

3-month delayed treatment with Baltimore HEARS intervention

Behavioral: Baltimore HEARSDevice: Baltimore HEARS

Interventions

Baltimore HEARSBEHAVIORAL

Tailored aural rehabilitation for participant and communication partner

Delayed Treatment GroupImmediate Treatment Group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Score ≤ 25 on the Montreal Cognitive Assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weinberg Senior Living Communities

Baltimore, Maryland, 21215, United States

Location

Related Publications (5)

  • Ventry IM, Weinstein BE. Identification of elderly people with hearing problems. ASHA. 1983 Jul;25(7):37-42. No abstract available.

    PMID: 6626295BACKGROUND

  • Weinstein BE. Validity of a screening protocol for identifying elderly people with hearing problems. ASHA. 1986 May;28(5):41-5. No abstract available.

    PMID: 3718608BACKGROUND

  • 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.

    PMID: 2307305BACKGROUND

  • 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.

    PMID: 7431205BACKGROUND

  • 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.

    PMID: 3393032BACKGROUND

Related Links

MeSH Terms

Conditions

Age-Related Hearing Impairment 1Communication

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Carrie Nieman
Organization
Johns Hopkins University School of Medicine Dept. Otolaryngology-HNS
cnieman1@jhmi.edu
3025368362

Study Officials

  • Frank Lin, MD, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2014

First Posted

January 27, 2014

Study Start

February 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

August 22, 2018

Results First Posted

September 6, 2017

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)