Aging and Cognitive Health Evaluation in Elders (ACHIEVE)

NCT ID: NCT03243422

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 977 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-04
• Study Completion Date: 2023-06-12

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.

Conditions

Aging; Cognitive Decline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Successful aging health education intervention

Individual sessions on healthy aging topics

Group Type: ACTIVE_COMPARATOR

Successful aging health education intervention

Intervention Type: 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.

Hearing intervention

Best practices hearing rehabilitative treatment

Group Type: ACTIVE_COMPARATOR

Hearing intervention

Intervention Type: 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.

Interventions

Successful aging health education intervention

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.

Intervention Type: OTHER

Hearing intervention

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 70 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of North Carolina

OTHER

Sponsor Role: collaborator

University of South Florida

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: collaborator

University of Mississippi Medical Center

OTHER

Sponsor Role: collaborator

Wake Forest University

OTHER

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank R Lin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Josef Coresh

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Comstock Center for Public Health Research

Hagerstown, Maryland, United States

University of Minnesota

Minneapolis, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Wake Forest University

Winston-Salem, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40441816 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40369891 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40354063 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39570588 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37478886 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32251012 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30364572 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

R01AG055426

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00008129

Identifier Type: -

Identifier Source: org_study_id