NCT03243422: ACHIEVE

Aging and Cognitive Health Evaluation in Elders (ACHIEVE)

Completed NA Results posted Last updated 1 February 2024

What this trial tests

NA trial testing Successful aging health education intervention in Aging in 977 participants. Completed in 12 June 2023.

Timeline

4 January 2018

Primary endpoint
30 November 2022

12 June 2023

Quick facts

Lead sponsor	Johns Hopkins Bloomberg School of Public Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	977
Start date	4 January 2018
Primary completion	30 November 2022
Estimated completion	12 June 2023
Sites	4 locations across United States

Drugs / interventions tested

• Successful aging health education intervention
• Hearing intervention

Conditions studied

• Aging — all drugs for Aging →
• Cognitive Decline — all drugs for Cognitive Decline →

Sponsor

Johns Hopkins Bloomberg School of Public Health

Who can join

Adults 70 to 84, any sex, with Aging or Cognitive Decline. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Global Cognitive Function Primary · 3 years

Mean change in global cognitive function in standard deviations from baseline to year 3 estimated from a linear mixed-effects model. Global cognitive function was defined as a factor score derived from the completion of a neurocognitive testing battery. The ACHIEVE study administers a neurocognitive testing battery annually, which includes the following cognitive tests: Delayed Word Recall, Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Word List, Incidental Learning, Logical Memory I and II, Word Fluency, Animal Naming, Boston Naming, Trail Making Test A and B, Digit Span

Group	Value	95% CI
Successful Aging Health Education Intervention	-0.202	-0.258 – -0.145
Hearing Intervention	-0.200	-0.256 – -0.144

Change in Cognition Memory Domain Secondary · 3 years

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 cognitio

Group	Value	95% CI
Successful Aging Health Education Intervention	-0.054	-0.128 – 0.020
Hearing Intervention	0.025	-0.053 – 0.103

Change in Cognition Executive Function Domain Secondary · 3 years

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 executiv

Group	Value	95% CI
Successful Aging Health Education Intervention	-0.248	-0.315 – -0.181
Hearing Intervention	-0.268	-0.339 – -0.197

Change in Cognition Language Domain Secondary · 3 years

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 ha

Group	Value	95% CI
Successful Aging Health Education Intervention	-0.155	-0.214 – -0.096
Hearing Intervention	-0.138	-0.199 – -0.077

Number of Participants Who Developed Cognitive Impairment Secondary · 3 years

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.

Group	Value	95% CI
Successful Aging Health Education Intervention	49
Hearing Intervention	45

3-year Global Cognitive Change Restricted to ARIC Participants Secondary · 3 year

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

Group	Value	95% CI
ARIC Only Successful Aging Health Education Intervention	-0.402	-0.536 – -0.267
ARIC Only Hearing Intervention	-0.211	-0.349 – -0.073

3-year Global Cognitive Change Restricted to De Novo Participants Secondary · 3 year

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

Group	Value	95% CI
De Novo Only Successful Aging Health Education Intervention	-0.151	-0.215 – -0.087
De Novo Only Hearing Intervention	-0.213	-0.277 – -0.148

Adverse events — posted to ClinicalTrials.gov

Time frame: Every six months after randomization, up to 3 years.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Successful Aging Health Education Intervention

Serious: 0/487 (0%)

Deaths: 20/487

Hearing Intervention

Serious: 0/490 (0%)

Deaths: 21/490

Other adverse events (3 terms — click to expand)

Reaction	System	Successful Aging Health Ed…	Hearing Intervention
Cerumen impaction	Ear and labyrinth disorders	—	—
Otitis externa	Ear and labyrinth disorders	—	—
Other	Ear and labyrinth disorders	—	—

Data from ClinicalTrials.gov NCT03243422 adverse events section.

Sponsor's own 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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Hearing intervention versus health education control to reduce cognitive decline in older adults with hearing loss in the USA (ACHIEVE): a multicentre, randomised controlled trial.
   Lin FR, Pike JR, Albert MS, Arnold M, et al · · 2023 · cited 311× · PMID 37478886 · DOI 10.1016/s0140-6736(23)01406-x
2. Hearing treatment for reducing cognitive decline: Design and methods of the Aging and Cognitive Health Evaluation in Elders randomized controlled trial.
   Deal JA, Goman AM, Albert MS, Arnold ML, et al · · 2018 · cited 81× · PMID 30364572 · DOI 10.1016/j.trci.2018.08.007
3. The Hearing Intervention for the Aging and Cognitive Health Evaluation in Elders Randomized Control Trial: Manualization and Feasibility Study.
   Sanchez VA, Arnold ML, Reed NS, Oree PH, et al · · 2020 · cited 29× · PMID 32251012 · DOI 10.1097/aud.0000000000000858
4. Considering hearing loss as a modifiable risk factor for dementia.
   Brewster KK, Deal JA, Lin FR, Rutherford BR. · · 2022 · cited 22× · PMID 36150235 · DOI 10.1080/14737175.2022.2128769
5. Blast-induced hearing loss suppresses hippocampal neurogenesis and disrupts long term spatial memory.
   Manohar S, Adler HJ, Chen GD, Salvi R. · · 2020 · cited 17× · PMID 32663733 · DOI 10.1016/j.heares.2020.108022
6. Loneliness and Social Network Characteristics Among Older Adults With Hearing Loss in the ACHIEVE Study.
   Huang AR, Reed NS, Deal JA, Arnold M, et al · · 2024 · cited 15× · PMID 37578190 · DOI 10.1093/gerona/glad196
7. Depression and Health-Related Quality of Life Among Older Adults With Hearing Loss in the ACHIEVE Study.
   Huang AR, Reed NS, Deal JA, Arnold M, et al · · 2024 · cited 14× · PMID 38016096 · DOI 10.1177/07334648231212291
8. Feasibility and Assessment of a Hybrid Audiology Service Delivery Model for Older Adult Hearing Aid Users: A Pilot Study.
   Arnold ML, Schwartz B, Neil H, Chisolm TH, et al · · 2022 · cited 10× · PMID 35503960 · DOI 10.1044/2022_aja-21-00200