Status:
COMPLETED
Aging and Cognitive Health Evaluation in Elders (ACHIEVE)
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborating Sponsors:
University of North Carolina
University of South Florida
Conditions:
Aging
Cognitive Decline
Eligibility:
All Genders
70-84 years
Phase:
NA
Brief Summary
The ACHIEVE study will be a randomized controlled trial nested within the infrastructure of the Atherosclerosis Risk in Communities (ARIC) study. We plan to enroll 850 70-84 year-old cognitively norma...
Detailed Description
The ACHIEVE study will be a randomized controlled trial nested within the infrastructure of the Atherosclerosis Risk in Communities (ARIC) study. We plan to enroll 850 70-84 year-old cognitively norma...
Eligibility Criteria
Inclusion
- Age 70-84 years. Individuals aged 70-84 at the time of randomization are eligible for participation. This age range will allow recruitment of participants who are at risk for cognitive decline but who may also be expected to survive for the duration of the trial. This age range is estimated to allow for potential participation of 61% of participants currently enrolled in the ARIC study.
- Community-dwelling.
- Fluent English-speaker.
- Residency. Participants must plan to reside in the local area for the study duration.
- Audiometric hearing impairment. Participants must have adult-onset hearing impairment with a four-frequency pure tone average (0.5, 1, 2, 4 kHz) in the better-hearing ear of ≥ 30 decibels (dB) and \<70 dB. This level of hearing impairment is the level at which individuals would be most likely to benefit from the use of conventional amplification devices such as hearing aids.
- Word Recognition in Quiet score ≥60% in the better ear. A word recognition in quiet score \<60% suggests hearing impairment that is too severe to benefit from conventional amplification devices such as hearing aids.
- 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; Participants must be at risk for cognitive decline in the range quantified well by neurocognitive testing, and so must be free from more substantial cognitive impairment at baseline.
- Willingness to participate be randomized and adhere to the protocol. 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 commit to adhere to the study protocol for the duration of the trial (3 years of a randomly assigned intervention).
Exclusion
- Self-reported disability in ≥ 2 or more Activities of Daily Living (ADL).
- Any self-reported hearing aid use in the past year. Trial participants will be randomized to hearing intervention or successful aging intervention and, therefore, participants cannot be receiving treatment for their hearing loss already.
- ARIC participants only: Diagnosis of adjudicated dementia based on a previous ARIC visit or participant required a proxy to assist with completing informed consent and responding to questions at ARIC Visit 6 or 7.
- Vision impairment (worse than 20/63 on MNREAD Acuity Chart). Participants who cannot see (with correction) well enough to complete the neurocognitive assessment are excluded.
- Medical contraindication to use of hearing aids (e.g., draining ear). Because hearing aids will be the primary device used in the hearing intervention, participants with medical contraindications to hearing aid use are excluded.
- Permanent 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. Because the impact of a conductive (versus a sensorineural) hearing loss on cognitive functioning may potentially differ and programming for hearing aids differs for conductive hearing loss, participants with permanent conductive hearing loss are excluded from the trial. Participants with an air-bone gap due to fluid in the ears or other resolvable medical issue may be enrolled in the trial following successful medical resolution of the cause of the air-bone gap.
- Unwilling to wear hearing aids on a regular (i.e., daily or near daily) basis.
Key Trial Info
Start Date :
January 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2023
Estimated Enrollment :
977 Patients enrolled
Trial Details
Trial ID
NCT03243422
Start Date
January 4 2018
End Date
June 12 2023
Last Update
February 1 2024
Active Locations (4)
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1
Johns Hopkins Comstock Center for Public Health Research
Hagerstown, Maryland, United States, 21740
2
University of Minnesota
Minneapolis, Minnesota, United States, 55455
3
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
4
Wake Forest University
Winston-Salem, North Carolina, United States, 27109