Clinical trial NCT03243422: Aging and Cognitive Health Evaluation in Elders (ACHIEVE)
Official title: Aging and Cognitive Health Evaluation in Elders (ACHIEVE) Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Cognitive Decline
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: University of North Carolina
name: University of South Florida
name: University of Pittsburgh
name: University of Mississippi Medical Center
name: Wake Forest University
name: University of Minnesota
name: National Institute on Aging (NIA)
First posted: 2017-08-09
Enrollment: 977
Sex: ALL
Minimum age (years): 70
Maximum age (years): 84
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Global Cognitive Function
timeFrame: 3 years
Secondary outcomes:
measure: Change in Cognition Memory Domain
timeFrame: 3 years
measure: Change in Cognition Executive Function Domain
timeFrame: 3 years
measure: Change in Cognition Language Domain
timeFrame: 3 years
measure: Number of Participants Who Developed Cognitive Impairment
timeFrame: 3 years
Other outcomes:
measure: 3-year Global Cognitive Change Restricted to ARIC Participants
timeFrame: 3 year
measure: 3-year Global Cognitive Change Restricted to De Novo Participants
timeFrame: 3 year
measure: Social Engagement
timeFrame: 3 years
measure: Loneliness
timeFrame: 3 years
measure: Physical Function: Lower Extremity Function
timeFrame: 3 years
measure: Physical Function: Grip Strength
timeFrame: 3 years
measure: Physical Function: Physical Activity
timeFrame: 3 years
measure: Self-reported Physical Ability
timeFrame: 3 years
measure: Self-reported Physical Activity
timeFrame: 3 years
measure: Depressive Symptoms
timeFrame: 3 years
measure: Hearing Handicap
timeFrame: 3 years
measure: Intervention Feedback
timeFrame: Gathered at 6 months post-baseline and 36 months post-baseline
measure: Physical Health
timeFrame: 3 years
measure: Mental Health
timeFrame: 3 years
measure: Hospitalizations
timeFrame: 3 years
Locations:
city: Hagerstown
country: United States
facility: Johns Hopkins Comstock Center for Public Health Research
state: Maryland
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
Study officials:
affiliation: Johns Hopkins University
name: Frank R Lin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Josef Coresh
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.