Trials / Completed
CompletedNCT03243422
Aging and Cognitive Health Evaluation in Elders (ACHIEVE)
Aging and Cognitive Health Evaluation in Elders (ACHIEVE) Randomized Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 977 (actual)
- Sponsor
- Johns Hopkins Bloomberg School of Public Health · Academic / Other
- Sex
- All
- Age
- 70 Years – 84 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-01-04
- Primary completion
- 2022-11-30
- Completion
- 2023-06-12
- First posted
- 2017-08-09
- Last updated
- 2024-02-01
- Results posted
- 2024-02-01
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03243422. Inclusion in this directory is not an endorsement.