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

• ClinicalTrials.gov Identifier: NCT03243422
• Recruitment Status: Completed
• First Posted: August 9, 2017
• Results First Posted: February 1, 2024
• Last Update Posted: February 1, 2024
• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: University of North Carolina; University of South Florida; University of Pittsburgh; University of Mississippi Medical Center; Wake Forest University; University of Minnesota; National Institute on Aging (NIA)
• Information provided by (Responsible Party): Johns Hopkins Bloomberg School of Public Health

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Aging; Cognitive Decline
• Interventions: Other: Successful aging health education intervention; Other: Hearing intervention
• Enrollment: 977

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.

Pre-assignment Details

Arm/Group Title	Successful Aging Health Education Intervention	Hearing Intervention
Arm/Group Description	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.	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.
Period Title: Overall Study
Started	487	490
Completed	436	440
Not Completed	51	50
Reason Not Completed
Death	20	21
Lost to Follow-up	9	21
Withdrawal by Subject	22	8

Baseline Characteristics

Arm/Group Title		Successful Aging Health Education Intervention	Hearing Intervention	Total
Arm/Group Description		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.	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.	Total of all reporting groups
Overall Number of Baseline Participants		487	490	977
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	487 participants	490 participants	977 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	0 0.0%	0 0.0%	0 0.0%
	>=65 years	487 100.0%	490 100.0%	977 100.0%
Age, Continuous [1]; Mean (Standard Deviation); Unit of measure: Years
Overall	Number Analyzed	487 participants	490 participants	977 participants
		77.0 (4.0)	76.5 (3.9)	76.8 (4.0)
ARIC participants	Number Analyzed	118 participants	120 participants	238 participants
		78.6 (2.9)	79.2 (2.9)	78.9 (2.9)
De Novo participants	Number Analyzed	369 participants	370 participants	739 participants
		76.5 (4.2)	75.7 (3.8)	76.1 (4.0)
		[1] Measure Analysis Population Description: Overall there were 977 participants enrolled, 238 were from ARIC and 739 were from De Novo
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
Overall	Number Analyzed	487 participants	490 participants	977 participants
	Female	259 53.2%	264 53.9%	523 53.5%
	Male	228 46.8%	226 46.1%	454 46.5%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	487 participants	490 participants	977 participants
	American Indian or Alaska Native	0 0.0%	1 0.2%	1 0.1%
	Asian	4 0.8%	2 0.4%	6 0.6%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	59 12.1%	53 10.8%	112 11.5%
	White	424 87.1%	434 88.6%	858 87.8%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	487 participants	490 participants	977 participants
		487 100.0%	490 100.0%	977 100.0%
Recruitment Source; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	487 participants	490 participants	977 participants
	ARIC	118 24.2%	120 24.5%	238 24.4%
	De Novo	369 75.8%	370 75.5%	739 75.6%
Field Sites; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	487 participants	490 participants	977 participants
	Forsyth County, NC	119 24.4%	117 23.9%	236 24.2%
	Jackson, MI	123 25.3%	120 24.5%	243 24.9%
	Minneapolis, Mn	116 23.8%	120 24.5%	236 24.2%
	Washington County, MD	129 26.5%	133 27.1%	262 26.8%
4-Frequency pure tone average dB; Mean (Standard Deviation); Unit of measure: dB
	Number Analyzed	487 participants	490 participants	977 participants
		39.3 (6.7)	39.5 (7.1)	39.4 (6.9)
Education (highest level obtained); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	487 participants	490 participants	977 participants
	Less than high school	18 3.7%	19 3.9%	37 3.8%
	High school, GED, or vocational school	212 43.5%	206 42.0%	418 42.8%
	College, graduate, or professional school	257 52.8%	264 53.9%	521 53.3%
	Missing	0 0.0%	1 0.2%	1 0.1%
APOE E4 gene; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	487 participants	490 participants	977 participants
	APOE gene present	114 23.4%	110 22.4%	224 22.9%
	APOE gene not present	345 70.8%	339 69.2%	684 70.0%
	Missing	28 5.7%	41 8.4%	69 7.1%

Outcome Measures

1. Primary Outcome

Title	Change in Global Cognitive Function
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Successful Aging Health Education Intervention	Hearing Intervention
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	487	490
Mean (95% Confidence Interval); Unit of Measure: score on a scale
	-0.202; (-0.258 to -0.145)	-0.200; (-0.256 to -0.144)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Successful Aging Health Education Intervention
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.96
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	Three-level linear mixed effects model with an unstructured covariance matrix from the baseline and the year 3 in-person neurocognitive assessment
Method of Estimation	Estimation Parameter	change in Standard Deviation
	Estimated Value	0.002
	Confidence Interval	(2-Sided) 95%; -0.077 to 0.081
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Change in Cognition Memory Domain
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Successful Aging Health Education Intervention	Hearing Intervention
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	487	490
Mean (95% Confidence Interval); Unit of Measure: score on a scale
	-0.054; (-0.128 to 0.020)	0.025; (-0.053 to 0.103)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Successful Aging Health Education Intervention, Hearing Intervention
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.15
	Comments	Secondary outcomes were evaluated with Hochberg modification to the Bonferroni adjustment estimates are considered statistically significant if the largest p-value is <0·05.
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.079
	Confidence Interval	(2-Sided) 95%; -0.029 to 0.187
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	Change in Cognition Executive Function Domain
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Successful Aging Health Education Intervention	Hearing Intervention
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	487	490
Mean (95% Confidence Interval); Unit of Measure: score on a scale
	-0.248; (-0.315 to -0.181)	-0.268; (-0.339 to -0.197)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Successful Aging Health Education Intervention, Hearing Intervention
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.69
	Comments	Secondary outcomes were evaluated with Hochberg modification to the Bonferroni adjustment estimates are considered statistically significant if the largest p-value is <0·05.
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-0.020
	Confidence Interval	(2-Sided) 95%; -0.118 to 0.078
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Change in Cognition Language Domain
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Successful Aging Health Education Intervention	Hearing Intervention
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	487	490
Mean (95% Confidence Interval); Unit of Measure: score on a scale
	-0.155; (-0.214 to -0.096)	-0.138; (-0.199 to -0.077)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Successful Aging Health Education Intervention, Hearing Intervention
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.70
	Comments	Secondary outcomes were evaluated with Hochberg modification to the Bonferroni adjustment estimates are considered statistically significant if the largest p-value is <0·05.
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.017
	Confidence Interval	(2-Sided) 95%; -0.070 to 0.104
	Estimation Comments	[Not Specified]

5. Secondary Outcome

Title	Number of Participants Who Developed Cognitive Impairment
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Successful Aging Health Education Intervention	Hearing Intervention
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	487	490
Measure Type: Count of Participants; Unit of Measure: Participants
	49 10.1%	45 9.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Successful Aging Health Education Intervention, Hearing Intervention
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.59
	Comments	Secondary outcomes were evaluated with Hochberg modification to the Bonferroni adjustment estimates are considered statistically significant if the largest p-value is <0·05.
	Method	Regression, Cox
	Comments	Discrete-time interval model
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95%; 0.61 to 1.33
	Estimation Comments	[Not Specified]

6. Other Pre-specified Outcome

Title	3-year Global Cognitive Change Restricted to ARIC Participants
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	ARIC Only Successful Aging Health Education Intervention	ARIC Only Hearing Intervention
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	118	120
Mean (95% Confidence Interval); Unit of Measure: score on a scale
	-0.402; (-0.536 to -0.267)	-0.211; (-0.349 to -0.073)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ARIC Only Successful Aging Health Education Intervention, ARIC Only Hearing Intervention
	Comments	Analysis was restricted to ARIC participants who were enrolled in ACHIEVE
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.027
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.191
	Confidence Interval	(2-Sided) 95%; 0.022 to 0.360
	Estimation Comments	[Not Specified]

7. Other Pre-specified Outcome

Title	3-year Global Cognitive Change Restricted to De Novo Participants
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	De Novo Only Successful Aging Health Education Intervention	De Novo Only Hearing Intervention
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	369	370
Mean (95% Confidence Interval); Unit of Measure: score on a scale
	-0.151; (-0.215 to -0.087)	-0.213; (-0.277 to -0.148)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	De Novo Only Successful Aging Health Education Intervention, De Novo Only Hearing Intervention
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.18
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-0.061
	Confidence Interval	(2-Sided) 95%; -0.151 to 0.028
	Estimation Comments	[Not Specified]

8. Other Pre-specified Outcome

Title	Social Engagement
Description	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

Outcome Measure Data Not Reported

9. Other Pre-specified Outcome

Title	Loneliness
Description	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

Outcome Measure Data Not Reported

10. Other Pre-specified Outcome

Title	Physical Function: Lower Extremity Function
Description	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

Outcome Measure Data Not Reported

11. Other Pre-specified Outcome

Title	Physical Function: Grip Strength
Description	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

Outcome Measure Data Not Reported

12. Other Pre-specified Outcome

Title	Physical Function: Physical Activity
Description	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

Outcome Measure Data Not Reported

13. Other Pre-specified Outcome

Title	Self-reported Physical Ability
Description	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

Outcome Measure Data Not Reported

14. Other Pre-specified Outcome

Title	Self-reported Physical Activity
Description	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

Outcome Measure Data Not Reported

15. Other Pre-specified Outcome

Title	Depressive Symptoms
Description	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

Outcome Measure Data Not Reported

16. Other Pre-specified Outcome

Title	Hearing Handicap
Description	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

Outcome Measure Data Not Reported

17. Other Pre-specified Outcome

Title	Intervention Feedback
Description	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

Outcome Measure Data Not Reported

18. Other Pre-specified Outcome

Title	Physical Health
Description	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

Outcome Measure Data Not Reported

19. Other Pre-specified Outcome

Title	Mental Health
Description	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

Outcome Measure Data Not Reported

20. Other Pre-specified Outcome

Title	Hospitalizations
Description	Number of hospitalizations (all cause) over the course of follow-up based on self-report
Time Frame	3 years

Outcome Measure Data Not Reported

Adverse Events

Time Frame	Every six months after randomization, up to 3 years.
Adverse Event Reporting Description	For ACHIEVE only otitis externa and cerumen impaction or ear foreign body requiring removal by a physician were considered adverse events. Death from any cause was considered a serious adverse event.
Arm/Group Title	Successful Aging Health Education Intervention		Hearing Intervention
Arm/Group Description	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.		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.
All-Cause Mortality
	Successful Aging Health Education Intervention		Hearing Intervention
	Affected / at Risk (%)		Affected / at Risk (%)
Total	20/487 (4.11%)		21/490 (4.29%)
Serious Adverse Events
	Successful Aging Health Education Intervention		Hearing Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/487 (0.00%)		0/490 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Successful Aging Health Education Intervention		Hearing Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/487 (3.49%)		41/490 (8.37%)
Ear and labyrinth disorders
Otitis externa † [1]	2/487 (0.41%)	2	9/490 (1.84%)	9
Cerumen impaction † [2]	15/487 (3.08%)	15	28/490 (5.71%)	28
Other † [3]	0/487 (0.00%)	0	4/490 (0.82%)	4
† Indicates events were collected by systematic assessment; [1] Otitis externa (outer ear infection); [2] Cerumen impaction or ear foreign body requiring removal by physician; [3] Includes left serous effusion, hearing aid dome stuck on the ear canal, fungal infection of the ear canal, and eustachian tube inflammation.

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Lisa Gravens-Mueller, Biostatistician/Supervisor
• Organization: University of North Carolina, Chapel Hill
• Phone: 919 962-3098
• EMail: lgravens@email.unc.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Johns Hopkins Bloomberg School of Public Health
• ClinicalTrials.gov Identifier: NCT03243422
• Other Study ID Numbers: IRB00008129; R01AG055426 ( U.S. NIH Grant/Contract )
• First Submitted: July 27, 2017
• First Posted: August 9, 2017
• Results First Submitted: November 21, 2023
• Results First Posted: February 1, 2024
• Last Update Posted: February 1, 2024