Trial Outcomes & Findings for Aging and Cognitive Health Evaluation in Elders (ACHIEVE) (NCT NCT03243422)

Eligible participants were randomized using 1:1 permuted block randomization, stratified by severity of hearing loss (PTA \<40 dB or ≥ 40 dB), recruitment source (ARIC or de novo), and field site, to either hearing intervention (HI) or a successful aging (SA) health education control intervention from January 2018 to October 2019. Eligible participants who were spouses/partners were randomized as a unit, stratified by recruitment source and field site.

Overall there were 977 participants enrolled, 238 were from ARIC and 739 were from De Novo

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.

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.

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.

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.

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.

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. Stratified by recruitment type ARIC vs De Novo.

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. Stratified by recruitment type ARIC vs De Novo.

Change from baseline to year 3 in social engagement, as assessed by the Cohen's Social Network Index (SNI) questionnaire, which asks about the number of people the participant has regular contact with (at least once every 2 weeks) within each of 12 different possible settings/types of contacts (e.g., relatives, church members, neighbors, etc.). Social engagement is quantified by evaluating the total number of people in the social network across all 12 settings/roles.

Change from baseline to year 3 in loneliness, as assessed using the University of California Los Angeles (UCLA) Loneliness Scale questionnaire. The UCLA Loneliness Scale is interviewer administered and consists of 20 items that participants rate using a 4-point Likert scale; 9 positively worded items are reverse-coded, and the average scores range from 1 to 4, with higher score indicating greater expression of loneliness.

Change from baseline to year 3 in lower extremity function, as assessed using the Short Physical Performance Battery (SPPB), which includes timed tests for usual gait speed, balance, and the ability to rise from a chair. Each of the 3 tests is scored from 0 to 4, with higher scores reflecting better lower extremity physical performance, and the total SPPB score is calculated as the sum of the 3 tests, with a range of 0 to 12, with higher scores reflecting better physical performance.

Change from baseline to year 3 in grip strength (kilograms of force) measured by a hand-held dynamometer, based on the best of two trials with the participant's preferred or best hand.

Change from baseline to year 3 in physical activity measured by accelerometry. Participants will use a wrist-worn device that is worn continuously for 7 days after baseline, and 7 days after each annual follow up. This measures the intensity, duration, and frequency of physical activity.

Change from baseline to year 3 measured using the falls and mobility questionnaire which records living circumstances, self-reported physical ability, fatigue, and falls.

Change from baseline to year 3 in self-reported physical activity measured using the Baecke Physical Activity Questionnaire, which includes questions about frequency of exercise/sports and leisure activities to generate composite scores of sports during leisure time (continuous measure between 1 and 5) and leisure time excluding sports (continuous measure between 1 and 5).

Change from baseline to year 3 in depressive symptoms, as assessed by the Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is an interviewer-administered scale that consists of 12 items which participants rate using a 3-point Likert scale; 2 positively worded items are reverse-coded. The first 11 items are summed to create a total score ranging from 0 to 22, with higher scores indicating greater expression of depression. The 12th item is a rating of hopelessness that is not included in the total score.

Change from baseline to year 3 measured on the Hearing Handicap for the Elderly Screening Version (HHIE-S) questionnaire, which is a 10-item questionnaire developed to assess how an individual perceives the social and emotional effects of hearing loss; scores range from 0 to 40, with higher scores suggestive of greater hearing handicap

A questionnaire that gathers feedback about the study intervention that participants are receiving. Participants rate how strongly they agree or disagree with a series of statements about the ACHIEVE study intervention they received.

Change from baseline to year 3 as assessed using the RAND-36, which is an interviewer-administered scale measuring a person's perceptions of their health and health-related quality of life; the physical component score is an algorithmically derived score with a normative mean of 50 and standard deviation of 10 (range 0 to 100), where higher scores indicate better physical health.

Change from baseline to year 3 as assessed using the RAND-36, which is an interviewer-administered scale measuring a person's perceptions of their health and health-related quality of life; the mental component score is an algorithmically derived score with a normative mean of 50 and standard deviation of 10 (range 0 to 100), where higher scores indicate better mental health.

Number of hospitalizations (all cause) over the course of follow-up based on self-report