Aging and Cognitive Health Evaluation in Elders (ACHIEVE) (ACHIEVE)
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|ClinicalTrials.gov Identifier: NCT03243422|
Recruitment Status : Recruiting
First Posted : August 9, 2017
Last Update Posted : April 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Aging Cognitive Decline||Other: Successful aging education intervention Other: Hearing intervention||Not Applicable|
The ACHIEVE study will be a randomized controlled trial nested within the Atherosclerosis Risk in Communities (ARIC) study. 850 70-84 year-old cognitively normal older adults with hearing loss will be randomized 1:1 to the hearing intervention (hearing needs assessment, fitting of hearing devices, education/counseling) or successful aging 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||850 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Aging and Cognitive Health Evaluation in Elders (ACHIEVE) Randomized Trial|
|Actual Study Start Date :||January 4, 2018|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||May 2022|
Active Comparator: Successful aging education intervention
Individual sessions on healthy aging topics
Other: Successful aging 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 Pittsburgh1. 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 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.
Active Comparator: Hearing intervention
Best practices hearing rehabilitative treatment
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.
- Cognitive decline [ Time Frame: 3 years ]Neurocognitive test battery global domain
- Dementia and mild cognitive impairment [ Time Frame: 3 years ]Time until composite outcome of adjudicated diagnosis of dementia, mild cognitive impairment (MCI), or 3 point decline in mini-mental state exam.
- Cognition: Memory domains [ Time Frame: 3 years ]Change from baseline to year 3 in the memory domain factor score
- Cognition: Executive function domains [ Time Frame: 3 years ]Change from baseline to year 3 in the executive function domain factor score
- Cognition: Language domain [ Time Frame: 3 years ]Change from baseline to year 3 in the language domain factor score
- Social engagement [ Time Frame: 3 years ]Change from baseline to year 3 on the Cohen's Social Network Index questionnaire
- Loneliness [ Time Frame: 3 years ]Change from baseline to year 3 on the University of California Los Angeles (UCLA) loneliness questionnaire
- Physical function: Lower extremity function [ Time Frame: 3 years ]Change from baseline to year 3 on the Short Physical Performance Battery, a series of physical performance tests designed to assess lower extremity function in older adults.
- Physical function: Grip strength [ Time Frame: 3 years ]Change from baseline to year 3 in grip strength measured by a hand held dynamometer.
- Physical function: Physical Activity [ Time Frame: 3 years ]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.
- Self-reported physical ability [ Time Frame: 3 years ]Change from baseline to year 3 measured using the falls and mobility questionnaire which records living circumstances, self-reported physical ability, fatigue, and falls
- Self-reported physical activity [ Time Frame: 3 years ]Change from baseline to year 3 measured on the Baecke Physical Activity Questionnaire
- Depressive symptoms [ Time Frame: 3 years ]Change from baseline to year 3 measured on the Center for Epidemiological Studies Depression and Hopelessness Scale (CES-D)
- Hearing handicap [ Time Frame: 3 years ]Change from baseline to year 3 measured on the Hearing Handicap for the Elderly Screening Version questionnaire
- Hospitalizations [ Time Frame: 3 years ]Number of hospitalizations since last study contact.
- Health related quality of life [ Time Frame: 3 years ]Change from baseline to year 3 measured with the Short Form Health Survey (SF-12v2) questionnaire.
- Intervention feedback [ Time Frame: Gathered at 6 months post-baseline and 36 months post-baseline ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03243422
|Contact: Adele M Goman, PhDemail@example.com|
|Contact: Frank R Lin, MD, PhDfirstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins Comstock Center for Public Health Research||Recruiting|
|Hagerstown, Maryland, United States, 21740|
|Contact: Melissa Minotti 301-791-1847 email@example.com|
|Contact: Josef Coresh 410-955-0495 firstname.lastname@example.org|
|United States, Minnesota|
|University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Lisa Miller email@example.com|
|Contact: James Pankow 612-624-2883 firstname.lastname@example.org|
|United States, Mississippi|
|University of Mississippi Medical Center||Recruiting|
|Jackson, Mississippi, United States, 39216|
|Contact: Stacee Naylor email@example.com|
|Contact: Thomas Mosley 601-984-2763 firstname.lastname@example.org|
|United States, North Carolina|
|Wake Forest University||Recruiting|
|Winston-Salem, North Carolina, United States, 27109|
|Contact: Joshua Evans email@example.com|
|Contact: Kathleen Hayden 336-716-2918 firstname.lastname@example.org|
|Principal Investigator:||Frank R Lin, MD, PhD||Johns Hopkins University|
|Principal Investigator:||Josef Coresh||Johns Hopkins University|