Aging and Cognitive Health Evaluation in Elders (ACHIEVE)

Not Applicable

Completed

Conditions: Cognitive Decline
Aging

Interventions: Other: Hearing intervention
Other: Successful aging health education intervention

Registration Number: NCT03243422

Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

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 normal older adults with hearing loss, who will be randomized 1:1 to the hearing intervention (hearing needs assessment, fitting of hearing devices, education/counseling) or successful aging health education intervention (individual sessions with a health educator covering healthy aging topics). Post-baseline, participants will be followed semi-annually for 3 years.

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 normal older adults with hearing loss, who will be randomized 1:1 to the hearing intervention (hearing needs assessment, fitting of hearing devices, education/counseling) or successful aging health education intervention (individual sessions with a health educator covering healthy aging topics). Post-baseline, participants will be followed semi-annually for 3 years.

Outcomes will include assessments of cognition, social functioning, physical functioning, and quality of life.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 977

Inclusion Criteria

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 Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hearing intervention	Hearing intervention	Best practices hearing rehabilitative treatment
Successful aging health education intervention	Successful aging health education intervention	Individual sessions on healthy aging topics

Primary Outcome Measures

Name	Time	Method
Change in Global Cognitive Function	3 years	Mean change in global cognitive function in standard deviations from baseline to year 3 estimated from a linear mixed-effects model. Global cognitive function was defined as a factor score derived from the completion of a neurocognitive testing battery. The ACHIEVE study administers a neurocognitive testing battery annually, which includes the following cognitive tests: Delayed Word Recall, Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Word List, Incidental Learning, Logical Memory I and II, Word Fluency, Animal Naming, Boston Naming, Trail Making Test A and B, Digit Span Backwards, and Digit Symbol Substitution. Factor analytic methods use all items from all tests in the battery to generate a single score of global cognitive function. The global cognitive function factor score has a minimum of -5 and a maximum of 4. Lower scores denote worse cognitive function.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Developed Cognitive Impairment	3 years	Incident cognitive impairment with the outcome defined as the first instance of (1) adjudicated diagnosis of dementia or mild cognitive impairment (MCI), (2) 3-point drop in the 30-item Mini-Mental State Exam (MMSE) administered in-person, or (3) a 3-point drop in a factor score derived from the 10-item MMSE orientation subscale and 11-item Blessed scale administered over the telephone and rescaled to be equivalent to the 30-item MMSE. The numbers below in the outcome measure data table represent the number of cases (participants) who developed cognitive impairment, within 3 years.
Change in Cognition Memory Domain	3 years	Mean change in cognition memory domain in standard deviations from baseline to year 3 estimated from a linear mixed-effects model. The cognition memory domain was defined as a factor score derived from the completion of a neurocognitive testing battery. The cognitive tests for the memory domain include Delayed Word Recall, CERAD Word List, Incidental Learning, and Logical Memory I and II. These tests have an underlying commonality or factor, that is unable to be directly measured, and factor analytic methods use items from the tests noted to generate a single overall memory score. The cognition memory domain factor score has a minimum of -5 and a maximum of 4. Lower scores denote worse cognitive function.
Change in Cognition Executive Function Domain	3 years	Mean change in cognitive executive function in standard deviations from baseline to year 3 estimated from a linear mixed-effects model. The executive function domain was defined as a factor score derived from the completion of a neurocognitive testing battery. The cognitive tests for the executive function domain include Trail Making Test A and B and Digit Symbol Substitution. These tests have an underlying commonality or factor, that is unable to be directly measured, and factor analytic methods use items from the tests noted to generate a single overall executive function score. The executive function cognitive factor score has a minimum of -5 and a maximum of 4. Lower scores denote worse cognitive function.
Change in Cognition Language Domain	3 years	Mean change in cognition language domain in standard deviations from baseline to year 3 estimated from a linear mixed-effects model. The cognition language domain as defined as a factor score derived from the completion of a neurocognitive testing battery. The cognitive tests for the language domain include Word Fluency, Animal Naming, and Boston Naming. These tests have an underlying commonality or factor, that is unable to be directly measured, and factor analytic methods use items from the tests noted to generate a single overall language score. The cognition language domain factor score has a minimum of -5 and a maximum of 4. Lower scores denote worse cognitive function.

Trial Locations

Locations (4): University of Mississippi Medical Center
🇺🇸
Jackson, Mississippi, United States
University of Minnesota
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Minneapolis, Minnesota, United States
Wake Forest University
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Winston-Salem, North Carolina, United States
Johns Hopkins Comstock Center for Public Health Research
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Hagerstown, Maryland, United States