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Aging, Cognition, and Hearing Evaluation in Elders Study (ACHIEVE-P)

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best practices hearing rehabilitative treatment
Successful aging intervention
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss

Eligibility Criteria

70 Years - 84 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria

  • Age 70-84 years.
  • Community-dwelling.
  • Fluent English-speaker.
  • Residency. Participants must plan to reside in the local area for the study duration (6 months).
  • Audiometric hearing impairment. Participants must have adult-onset hearing impairment with a pure tone average (0.5, 1, and 2 kHz) in the better-hearing ear of ≥ 30 decibels and <70 dB.
  • Word Recognition in Quiet score >60% bilaterally.
  • Mini-Mental State Exam (MMSE) score ≥ 23 for individuals with high-school degree or less; Mini-Mental State Exam (MMSE) score ≥ 25 for individuals with some college or more
  • Willingness to participate. Participants must be willing and able to consent to participate in the study, be willing to be randomized to either the Hearing intervention or to the Successful Aging intervention, and be willing to follow the study protocol for the duration of the trial.

Exclusion Criteria

Potential candidates for enrollment who meet one or more of t he following criteria are excluded from participation in the study:

  • Self-reported disability in ≥ 2 or more Activities of Daily Living (ADL)
  • Self-reported hearing aid use in the past year (>5 hours/week).
  • Vision impairment (worse than 20/40 on MN Near Vision Card).
  • Medical contraindication to use of hearing aids (e.g., draining ear).
  • Conductive hearing impairment as determined by a difference in air audiometry and bone audiometry ("air-bone gap") greater than 15 dB in 2 or more contiguous frequencies in both ears.
  • Unwilling to wear hearing aids on a regular (i.e., daily or near daily) basis
  • No participants are excluded based on race or sex

Sites / Locations

  • Johns Hopkins Comstock Center for Public Health Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Hearing intervention

Successful aging intervention

Arm Description

Best practices hearing rehabilitative treatment

Successful aging intervention

Outcomes

Primary Outcome Measures

Hearing Handicap Inventory for the Elderly (HHIE)

Secondary Outcome Measures

Neurocognitive test battery including Trail Making Test, Delayed Word Recall, and other tests

Full Information

First Posted
April 1, 2015
Last Updated
April 6, 2021
Sponsor
Johns Hopkins University
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT02412254
Brief Title
Aging, Cognition, and Hearing Evaluation in Elders Study
Acronym
ACHIEVE-P
Official Title
Aging, Cognition, and Hearing Evaluation in Elders Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
March 8, 2021 (Actual)
Study Completion Date
March 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators will conduct a small pilot study that will randomize ~ 40 70-84 year-old adults with hearing loss to best-practices hearing rehabilitative treatment (hearing assessment, counseling, fitting of amplification devices) versus a successful aging intervention (one-on-one counseling/education sessions on successful aging topics). Participants will be followed for 6 months, and outcomes will focus on communication, quality of life, cognition, and other functional surveys. This pilot study is in preparation for a larger planned trial to investigate if hearing loss treatment can reduce cognitive decline and dementia in older adults.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Hearing intervention
Arm Type
Active Comparator
Arm Description
Best practices hearing rehabilitative treatment
Arm Title
Successful aging intervention
Arm Type
Placebo Comparator
Arm Description
Successful aging intervention
Intervention Type
Other
Intervention Name(s)
Best practices hearing rehabilitative treatment
Intervention Description
Intervention comprises hearing needs assessment, counselling, sensory management with amplification devices, and rehabilitative training.
Intervention Type
Other
Intervention Name(s)
Successful aging intervention
Intervention Description
One-on-one education sessions on healthy aging topics (cancer screening, smoking cessation, etc.) between a trainer and participant
Primary Outcome Measure Information:
Title
Hearing Handicap Inventory for the Elderly (HHIE)
Time Frame
6 month follow-up
Secondary Outcome Measure Information:
Title
Neurocognitive test battery including Trail Making Test, Delayed Word Recall, and other tests
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria Age 70-84 years. Community-dwelling. Fluent English-speaker. Residency. Participants must plan to reside in the local area for the study duration (6 months). Audiometric hearing impairment. Participants must have adult-onset hearing impairment with a pure tone average (0.5, 1, and 2 kHz) in the better-hearing ear of ≥ 30 decibels and <70 dB. Word Recognition in Quiet score >60% bilaterally. Mini-Mental State Exam (MMSE) score ≥ 23 for individuals with high-school degree or less; Mini-Mental State Exam (MMSE) score ≥ 25 for individuals with some college or more Willingness to participate. Participants must be willing and able to consent to participate in the study, be willing to be randomized to either the Hearing intervention or to the Successful Aging intervention, and be willing to follow the study protocol for the duration of the trial. Exclusion Criteria Potential candidates for enrollment who meet one or more of t he following criteria are excluded from participation in the study: Self-reported disability in ≥ 2 or more Activities of Daily Living (ADL) Self-reported hearing aid use in the past year (>5 hours/week). Vision impairment (worse than 20/40 on MN Near Vision Card). Medical contraindication to use of hearing aids (e.g., draining ear). Conductive hearing impairment as determined by a difference in air audiometry and bone audiometry ("air-bone gap") greater than 15 dB in 2 or more contiguous frequencies in both ears. Unwilling to wear hearing aids on a regular (i.e., daily or near daily) basis No participants are excluded based on race or sex
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Lin
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Comstock Center for Public Health Research
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29067347
Citation
Deal JA, Albert MS, Arnold M, Bangdiwala SI, Chisolm T, Davis S, Eddins A, Glynn NW, Goman AM, Minotti M, Mosley T, Rebok GW, Reed N, Rodgers E, Sanchez V, Sharrett AR, Coresh J, Lin FR. A randomized feasibility pilot trial of hearing treatment for reducing cognitive decline: Results from the Aging and Cognitive Health Evaluation in Elders Pilot Study. Alzheimers Dement (N Y). 2017 Jun 21;3(3):410-415. doi: 10.1016/j.trci.2017.06.003. eCollection 2017 Sep.
Results Reference
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Aging, Cognition, and Hearing Evaluation in Elders Study

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