Aging and Cognitive Health Evaluation in Elders (ACHIEVE)

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.

Conditions

• Aging
• Cognitive Decline

Interventions

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.

OTHER

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.

Sponsors & Collaborators

• University of North Carolina

  collaborator OTHER

• University of South Florida

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• University of Mississippi Medical Center

  collaborator OTHER

• Wake Forest University

  collaborator OTHER

• University of Minnesota

  collaborator OTHER

• National Institute on Aging (NIA)

  collaborator NIH

• Johns Hopkins Bloomberg School of Public Health

  lead OTHER

Principal Investigators

• Frank R Lin, MD, PhD · Johns Hopkins University

• Josef Coresh · Johns Hopkins University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

70 Years

Max Age

84 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-01-04

Primary Completion

2022-11-30

Completion

2023-06-12

Countries

• United States

Study Locations