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Aging and Cognitive Health Evaluation in Elders (ACHIEVE)

Aging and Cognitive Health Evaluation in Elders (ACHIEVE) Randomized Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03243422
Acronym
ACHIEVE
Enrollment
977
Registered
2017-08-09
Start date
2018-01-04
Completion date
2023-06-12
Last updated
2024-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Cognitive Decline

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.

Interventions

OTHERSuccessful 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.

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.

Sponsors

University of North Carolina
CollaboratorOTHER
University of South Florida
CollaboratorOTHER
University of Pittsburgh
CollaboratorOTHER
University of Mississippi Medical Center
CollaboratorOTHER
Wake Forest University
CollaboratorOTHER
University of Minnesota
CollaboratorOTHER
National Institute on Aging (NIA)
CollaboratorNIH
Johns Hopkins Bloomberg School of Public Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
70 Years to 84 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Global Cognitive Function3 yearsMean 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.

Secondary

MeasureTime frameDescription
Change in Cognition Memory Domain3 yearsMean 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.
Change in Cognition Executive Function Domain3 yearsMean 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.
Change in Cognition Language Domain3 yearsMean 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.
Number of Participants Who Developed Cognitive Impairment3 yearsIncident 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.

Other

MeasureTime frameDescription
Physical Function: Lower Extremity Function3 yearsChange 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.
Physical Function: Physical Activity3 yearsChange 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.
Self-reported Physical Ability3 yearsChange from baseline to year 3 measured using the falls and mobility questionnaire which records living circumstances, self-reported physical ability, fatigue, and falls.
Self-reported Physical Activity3 yearsChange 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).
Depressive Symptoms3 yearsChange 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.
Physical Function: Grip Strength3 yearsChange 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.
Intervention FeedbackGathered at 6 months post-baseline and 36 months post-baselineA 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.
Physical Health3 yearsChange 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.
Mental Health3 yearsChange 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.
Hospitalizations3 yearsNumber of hospitalizations (all cause) over the course of follow-up based on self-report
Hearing Handicap3 yearsChange 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
3-year Global Cognitive Change Restricted to ARIC Participants3 yearMean 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.
3-year Global Cognitive Change Restricted to De Novo Participants3 yearMean 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.
Social Engagement3 yearsChange 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.
Loneliness3 yearsChange 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.

Countries

United States

Participant flow

Recruitment details

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.

Participants by arm

ArmCount
Successful Aging Health Education Intervention
Individual sessions on healthy aging topics 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.
487
Hearing Intervention
Best practices hearing rehabilitative treatment 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.
490
Total977

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath2021
Overall StudyLost to Follow-up921
Overall StudyWithdrawal by Subject228

Baseline characteristics

CharacteristicSuccessful Aging Health Education InterventionTotalHearing Intervention
4-Frequency pure tone average dB39.3 dB
STANDARD_DEVIATION 6.7
39.4 dB
STANDARD_DEVIATION 6.9
39.5 dB
STANDARD_DEVIATION 7.1
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
487 Participants977 Participants490 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous
ARIC participants
78.6 years
STANDARD_DEVIATION 2.9
78.9 years
STANDARD_DEVIATION 2.9
79.2 years
STANDARD_DEVIATION 2.9
Age, Continuous
De Novo participants
76.5 years
STANDARD_DEVIATION 4.2
76.1 years
STANDARD_DEVIATION 4
75.7 years
STANDARD_DEVIATION 3.8
Age, Continuous
Overall
77.0 years
STANDARD_DEVIATION 4
76.8 years
STANDARD_DEVIATION 4
76.5 years
STANDARD_DEVIATION 3.9
APOE E4 gene
APOE gene not present
345 Participants684 Participants339 Participants
APOE E4 gene
APOE gene present
114 Participants224 Participants110 Participants
APOE E4 gene
Missing
28 Participants69 Participants41 Participants
Education (highest level obtained)
College, graduate, or professional school
257 Participants521 Participants264 Participants
Education (highest level obtained)
High school, GED, or vocational school
212 Participants418 Participants206 Participants
Education (highest level obtained)
Less than high school
18 Participants37 Participants19 Participants
Education (highest level obtained)
Missing
0 Participants1 Participants1 Participants
Field Sites
Forsyth County, NC
119 Participants236 Participants117 Participants
Field Sites
Jackson, MI
123 Participants243 Participants120 Participants
Field Sites
Minneapolis, Mn
116 Participants236 Participants120 Participants
Field Sites
Washington County, MD
129 Participants262 Participants133 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Asian
4 Participants6 Participants2 Participants
Race (NIH/OMB)
Black or African American
59 Participants112 Participants53 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
424 Participants858 Participants434 Participants
Recruitment Source
ARIC
118 Participants238 Participants120 Participants
Recruitment Source
De Novo
369 Participants739 Participants370 Participants
Region of Enrollment
United States
487 Participants977 Participants490 Participants
Sex: Female, Male
Overall
Female
259 Participants523 Participants264 Participants
Sex: Female, Male
Overall
Male
228 Participants454 Participants226 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
20 / 48721 / 490
other
Total, other adverse events
17 / 48741 / 490
serious
Total, serious adverse events
0 / 4870 / 490

Outcome results

Primary

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

ArmMeasureValue (MEAN)
Successful Aging Health Education InterventionChange in Global Cognitive Function-0.202 score on a scale
Hearing InterventionChange in Global Cognitive Function-0.200 score on a scale
p-value: 0.9695% CI: [-0.077, 0.081]Mixed Models Analysis
Secondary

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

ArmMeasureValue (MEAN)
Successful Aging Health Education InterventionChange in Cognition Executive Function Domain-0.248 score on a scale
Hearing InterventionChange in Cognition Executive Function Domain-0.268 score on a scale
p-value: 0.6995% CI: [-0.118, 0.078]Mixed Models Analysis
Secondary

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

ArmMeasureValue (MEAN)
Successful Aging Health Education InterventionChange in Cognition Language Domain-0.155 score on a scale
Hearing InterventionChange in Cognition Language Domain-0.138 score on a scale
p-value: 0.795% CI: [-0.07, 0.104]Mixed Models Analysis
Secondary

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

ArmMeasureValue (MEAN)
Successful Aging Health Education InterventionChange in Cognition Memory Domain-0.054 score on a scale
Hearing InterventionChange in Cognition Memory Domain0.025 score on a scale
p-value: 0.1595% CI: [-0.029, 0.187]Mixed Models Analysis
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Successful Aging Health Education InterventionNumber of Participants Who Developed Cognitive Impairment49 Participants
Hearing InterventionNumber of Participants Who Developed Cognitive Impairment45 Participants
p-value: 0.5995% CI: [0.61, 1.33]Regression, Cox
Other Pre-specified

3-year Global Cognitive Change Restricted to ARIC Participants

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.

Time frame: 3 year

Population: ARIC participants participating in ACHIEVE were randomized to either hearing intervention or successful aging health education intervention.

ArmMeasureValue (MEAN)
Successful Aging Health Education Intervention3-year Global Cognitive Change Restricted to ARIC Participants-0.402 score on a scale
Hearing Intervention3-year Global Cognitive Change Restricted to ARIC Participants-0.211 score on a scale
Comparison: Analysis was restricted to ARIC participants who were enrolled in ACHIEVEp-value: 0.02795% CI: [0.022, 0.36]Mixed Models Analysis
Other Pre-specified

3-year Global Cognitive Change Restricted to De Novo Participants

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.

Time frame: 3 year

Population: De Novo participants participating in ACHIEVE were randomized to either hearing intervention or successful aging health education intervention.

ArmMeasureValue (MEAN)
Successful Aging Health Education Intervention3-year Global Cognitive Change Restricted to De Novo Participants-0.151 score on a scale
Hearing Intervention3-year Global Cognitive Change Restricted to De Novo Participants-0.213 score on a scale
p-value: 0.1895% CI: [-0.151, 0.028]Mixed Models Analysis
Other Pre-specified

Depressive Symptoms

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.

Time frame: 3 years

Other Pre-specified

Hearing Handicap

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

Time frame: 3 years

Other Pre-specified

Hospitalizations

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

Time frame: 3 years

Other Pre-specified

Intervention Feedback

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.

Time frame: Gathered at 6 months post-baseline and 36 months post-baseline

Other Pre-specified

Loneliness

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.

Time frame: 3 years

Other Pre-specified

Mental 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.

Time frame: 3 years

Other Pre-specified

Physical Function: Grip Strength

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.

Time frame: 3 years

Other Pre-specified

Physical Function: Lower Extremity Function

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.

Time frame: 3 years

Other Pre-specified

Physical Function: Physical Activity

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.

Time frame: 3 years

Other Pre-specified

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 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.

Time frame: 3 years

Other Pre-specified

Self-reported Physical Ability

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

Time frame: 3 years

Other Pre-specified

Self-reported Physical Activity

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).

Time frame: 3 years

Other Pre-specified

Social Engagement

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.

Time frame: 3 years

Source: ClinicalTrials.gov · Data processed: Aug 23, 2026