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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
977
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.
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.
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
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.
Time frame: 3 years
Change in Cognition Memory Domain
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.
Time frame: 3 years
Change in Cognition Executive Function Domain
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.
Time frame: 3 years
Change in Cognition Language Domain
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.
Time frame: 3 years
Number of Participants Who Developed Cognitive Impairment
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.
Time frame: 3 years
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