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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02412254
First Posted: April 9, 2015
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Frank Lin, Johns Hopkins University
  Purpose
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.

Condition Intervention
Hearing Loss Other: Best practices hearing rehabilitative treatment Other: Successful aging intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aging, Cognition, and Hearing Evaluation in Elders Pilot Study

Resource links provided by NLM:


Further study details as provided by Frank Lin, Johns Hopkins University:

Primary Outcome Measures:
  • Hearing Handicap Inventory for the Elderly (HHIE) [ Time Frame: 6 month follow-up ]

Secondary Outcome Measures:
  • Neurocognitive test battery including Trail Making Test, Delayed Word Recall, and other tests [ Time Frame: 6 months ]

Enrollment: 40
Study Start Date: May 2015
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hearing intervention
Best practices hearing rehabilitative treatment
Other: Best practices hearing rehabilitative treatment
Intervention comprises hearing needs assessment, counselling, sensory management with amplification devices, and rehabilitative training.
Placebo Comparator: Successful aging intervention
Successful aging intervention
Other: Successful aging intervention
One-on-one education sessions on healthy aging topics (cancer screening, smoking cessation, etc.) between a trainer and participant

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years to 84 Years   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02412254


Locations
United States, Maryland
Johns Hopkins Comstock Center for Public Health Research
Hagerstown, Maryland, United States, 21740
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Frank Lin Johns Hopkins University
  More Information

Responsible Party: Frank Lin, Associate Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02412254     History of Changes
Other Study ID Numbers: ACHIEVE-P-1
First Submitted: April 1, 2015
First Posted: April 9, 2015
Last Update Posted: March 3, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms