Aging and Cognitive Health Evaluation in Elders (ACHIEVE)
Condition: Aging; Cognitive Decline
MeSH terms: Cognitive Dysfunction
Study type: Interventional

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.
    

Intervention name(s): Successful aging health education intervention; Hearing intervention
Intervention type(s): Other; Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment