Aging and Cognitive Health Evaluation in Elders (ACHIEVE)

Aging Clinical Trial

— ACHIEVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03243422
• Other study ID #: IRB00008129
• Secondary ID: R01AG055426
• Status: Completed
• Phase: N/A
• Start date: January 4, 2018
• Est. completion date: June 12, 2023

Study information

• Verified date: January 2024
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 977
• Est. completion date: June 12, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years to 84 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Cognitive Decline
• Cognitive Dysfunction

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins Comstock Center for Public Health Research	Hagerstown	Maryland
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	University of Minnesota	Minneapolis	Minnesota
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (8)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	3 year
Other	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.	3 year
Other	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.	3 years
Other	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.	3 years
Other	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.	3 years
Other	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.	3 years
Other	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.	3 years
Other	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.	3 years
Other	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).	3 years
Other	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.	3 years
Other	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	3 years
Other	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.	Gathered at 6 months post-baseline and 36 months post-baseline
Other	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.	3 years
Other	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.	3 years
Other	Hospitalizations	Number of hospitalizations (all cause) over the course of follow-up based on self-report	3 years
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.	3 years
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.	3 years
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.	3 years
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.	3 years
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.	3 years