Aging and Cognitive Health Evaluation in Elders (ACHIEVE)

NCT03243422 | Completed Results DMC

• 2 other identifiers: IRB00008129R01AG055426
• Study Type: interventional
• Target: 977
• Locations: 1 country
• Sites: 4

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.

Conditions

Aging; Cognitive Decline

Outcome Measures

Primary Outcomes (1)

• Change in Global Cognitive Function

  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.

  3 years

Secondary Outcomes (4)

• Change in Cognition Memory Domain

  3 years

• Change in Cognition Executive Function Domain

  3 years

• Change in Cognition Language Domain

  3 years

• Number of Participants Who Developed Cognitive Impairment

  3 years

Other Outcomes (15)

• 3-year Global Cognitive Change Restricted to ARIC Participants

  3 year

• 3-year Global Cognitive Change Restricted to De Novo Participants

  3 year

• Social Engagement

  3 years

Study Arms (2)

Successful aging health education intervention

ACTIVE COMPARATOR

Individual sessions on healthy aging topics

Other: Successful aging health education intervention

Hearing intervention

ACTIVE COMPARATOR

Best practices hearing rehabilitative treatment

Other: Hearing intervention

Interventions

Successful aging health education intervention OTHER

The Successful Aging intervention will follow the protocol and materials developed for the 10 Keys™ to Healthy Aging program by the Center for Aging and Population Health Prevention Research Center at the University of Pittsburgh. This interactive, dynamic program informs older adults about risk factors for diseases. Participants will meet individually with a health educator certified to administer the program every 2-3 weeks for a total of 4 visits over approximately 8-10 weeks, and the session content will focus on a "Key". Each session will also include a 5-10 minute active upper body extremity stretching program as used in the Lifestyle Interventions and Independence for Elders (LIFE) study. Participants will return for booster sessions semi-annually beginning at 6 months post-randomization.

Successful aging health education intervention

Hearing intervention OTHER

The hearing intervention consists of fitting with hearing aids and other hearing assistive technologies plus four 1-hour comprehensive, individualized hearing rehabilitation sessions spaced over the 2-3 months post-randomization designed to provide all of the active components of the intervention. Hearing aids are instructed to be worn on a daily basis for study duration. Audiologic outcomes (e.g., hearing aid data logging, real ear measures, speech in noise, etc.) to verify the best-practices hearing intervention are gathered during study intervention visits and semi-annually beginning at 6 months post-randomization.

Hearing intervention

Eligibility Criteria

• Age: 70 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• University of North Carolina: collaborator
• University of South Florida: collaborator
• University of Pittsburgh: collaborator
• University of Mississippi Medical Center: collaborator
• Wake Forest University: collaborator
• University of Minnesota: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (4)

Johns Hopkins Comstock Center for Public Health Research

Hagerstown, Maryland, 21740, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27109, United States

Location

Related Publications (7)

• Goman AM, Tan N, Pike JR, Bessen SY, Chen ZS, Huang AR, Arnold ML, Burgard S, Chisolm TH, Couper D, Deal JA, Glynn NW, Gmelin T, Gravens-Mueller L, Hayden KM, Martinez-Amezcua P, Mitchell CM, Pankow JS, Reed NS, Sanchez VA, Schrack JA, Sullivan KJ, Coresh J, Lin FR; ACHIEVE Collaborative Research Group. Effects of hearing intervention on falls in older adults: findings from a secondary analysis of the ACHIEVE randomised controlled trial. Lancet Public Health. 2025 Jun;10(6):e492-e502. doi: 10.1016/S2468-2667(25)00088-X.

  PMID: 40441816 DERIVED

• Pike JR, Huang AR, Reed NS, Arnold M, Chisolm T, Couper D, Deal JA, Glynn NW, Goman AM, Hayden KM, Mitchell CM, Pankow JS, Sanchez V, Sullivan KJ, Tan NS, Coresh J, Lin FR; ACHIEVE Collaborative Research Group. Cognitive benefits of hearing intervention vary by risk of cognitive decline: A secondary analysis of the ACHIEVE trial. Alzheimers Dement. 2025 May;21(5):e70156. doi: 10.1002/alz.70156.

  PMID: 40369891 DERIVED

• Reed NS, Chen J, Huang AR, Pike JR, Arnold M, Burgard S, Chen Z, Chisolm T, Couper D, Cudjoe TKM, Deal JA, Goman AM, Glynn NW, Gmelin T, Gravens-Mueller L, Hayden KM, Mitchell CM, Mosley T, Oh ES, Pankow JS, Sanchez VA, Schrack JA, Coresh J, Lin FR; ACHIEVE Collaborative Research Group. Hearing Intervention, Social Isolation, and Loneliness: A Secondary Analysis of the ACHIEVE Randomized Clinical Trial. JAMA Intern Med. 2025 Jul 1;185(7):797-806. doi: 10.1001/jamainternmed.2025.1140.

  PMID: 40354063 DERIVED

• Huang AR, Morales EG, Arnold ML, Burgard S, Couper D, Deal JA, Glynn NW, Gmelin T, Goman AM, Gravens-Mueller L, Hayden KM, Mitchell CM, Pankow JS, Pike JR, Reed NS, Sanchez VA, Schrack JA, Sullivan KJ, Coresh J, Lin FR, Chisolm TH; ACHIEVE Collaborative Research Group. A Hearing Intervention and Health-Related Quality of Life in Older Adults: A Secondary Analysis of the ACHIEVE Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2446591. doi: 10.1001/jamanetworkopen.2024.46591.

  PMID: 39570588 DERIVED

• Lin FR, Pike JR, Albert MS, Arnold M, Burgard S, Chisolm T, Couper D, Deal JA, Goman AM, Glynn NW, Gmelin T, Gravens-Mueller L, Hayden KM, Huang AR, Knopman D, Mitchell CM, Mosley T, Pankow JS, Reed NS, Sanchez V, Schrack JA, Windham BG, Coresh J; ACHIEVE Collaborative Research Group. Hearing intervention versus health education control to reduce cognitive decline in older adults with hearing loss in the USA (ACHIEVE): a multicentre, randomised controlled trial. Lancet. 2023 Sep 2;402(10404):786-797. doi: 10.1016/S0140-6736(23)01406-X. Epub 2023 Jul 18.

  PMID: 37478886 DERIVED

• Sanchez VA, Arnold ML, Reed NS, Oree PH, Matthews CR, Clock Eddins A, Lin FR, Chisolm TH. The Hearing Intervention for the Aging and Cognitive Health Evaluation in Elders Randomized Control Trial: Manualization and Feasibility Study. Ear Hear. 2020 Sep/Oct;41(5):1333-1348. doi: 10.1097/AUD.0000000000000858.

  PMID: 32251012 DERIVED

• Deal JA, Goman AM, Albert MS, Arnold ML, Burgard S, Chisolm T, Couper D, Glynn NW, Gmelin T, Hayden KM, Mosley T, Pankow JS, Reed N, Sanchez VA, Richey Sharrett A, Thomas SD, Coresh J, Lin FR. Hearing treatment for reducing cognitive decline: Design and methods of the Aging and Cognitive Health Evaluation in Elders randomized controlled trial. Alzheimers Dement (N Y). 2018 Oct 5;4:499-507. doi: 10.1016/j.trci.2018.08.007. eCollection 2018.

  PMID: 30364572 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Lisa Gravens-Mueller, Biostatistician/Supervisor
• Organization: University of North Carolina, Chapel Hill

lgravens@email.unc.edu

919 962-3098

Study Officials

• Frank R Lin, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Josef Coresh

  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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 9, 2017
• Study Start: January 4, 2018
• Primary Completion: November 30, 2022
• Study Completion: June 12, 2023
• Last Updated: February 1, 2024
• Results First Posted: February 1, 2024

Record last verified: 2024-01

Locations

US (4)