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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 12, 2019
Sponsor:
Collaborators:
University of North Carolina
University of South Florida
University of Pittsburgh
University of Mississippi Medical Center
Wake Forest University
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Tracking Information
First Submitted Date  ICMJE July 27, 2017
First Posted Date  ICMJE August 9, 2017
Last Update Posted Date April 12, 2019
Actual Study Start Date  ICMJE January 4, 2018
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2017)
Cognitive decline [ Time Frame: 3 years ]
Neurocognitive test battery global domain
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03243422 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aging and Cognitive Health Evaluation in Elders (ACHIEVE)
Official Title  ICMJE Aging and Cognitive Health Evaluation in Elders (ACHIEVE) Randomized Trial
Brief Summary 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.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Aging
  • Cognitive Decline
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: Successful aging education intervention
    Individual sessions on healthy aging topics
    Intervention: Other: Successful aging education intervention
  • Active Comparator: Hearing intervention
    Best practices hearing rehabilitative treatment
    Intervention: Other: Hearing intervention
Publications * Deal JA, Goman AM, Albert MS, Arnold ML, Burgard S, Chisolm T, Couper D, Glynn NW, Gmelin T, Hayden KM, Mosley T, Pankow JS, Reed N, Sanchez VA, Richey Sharrett A, Thomas SD, Coresh J, Lin FR. Hearing treatment for reducing cognitive decline: Design and methods of the Aging and Cognitive Health Evaluation in Elders randomized controlled trial. Alzheimers Dement (N Y). 2018 Oct 5;4:499-507. doi: 10.1016/j.trci.2018.08.007. eCollection 2018.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 3, 2017)
850
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 70-84 years. Individuals aged 70-84 at the time of randomization are eligible for participation. This age range will allow recruitment of participants who are at risk for cognitive decline but who may also be expected to survive for the duration of the trial. This age range is estimated to allow for potential participation of 61% of participants currently enrolled in the ARIC study.
  • Community-dwelling.
  • Fluent English-speaker.
  • Residency. Participants must plan to reside in the local area for the study duration.
  • Audiometric hearing impairment. Participants must have adult-onset hearing impairment with a four-frequency pure tone average (0.5, 1, 2, 4 kHz) in the better-hearing ear of ≥ 30 decibels (dB) and <70 dB. This level of hearing impairment is the level at which individuals would be most likely to benefit from the use of conventional amplification devices such as hearing aids.
  • Word Recognition in Quiet score ≥60% in the better ear. A word recognition in quiet score <60% suggests hearing impairment that is too severe to benefit from conventional amplification devices such as hearing aids.
  • Mini-Mental State Exam (MMSE) score ≥ 23 for individuals with high-school degree or less; Mini-Mental State Exam (MMSE) score ≥ 25 for individuals with some college or more; Participants must be at risk for cognitive decline in the range quantified well by neurocognitive testing, and so must be free from more substantial cognitive impairment at baseline.
  • Willingness to participate be randomized and adhere to the protocol. Participants must be willing and able to consent to participate in the study, be willing to be randomized to either the Hearing intervention or to the Successful Aging intervention, and be willing to commit to adhere to the study protocol for the duration of the trial (3 years of a randomly assigned intervention).

Exclusion Criteria:

  • Self-reported disability in ≥ 2 or more Activities of Daily Living (ADL)
  • Any self-reported hearing aid use in the past year. Trial participants will be randomized to hearing intervention or successful aging intervention and, therefore, participants cannot be currently already receiving treatment for their hearing loss.
  • ARIC participants only: Diagnosis of adjudicated dementia based on a previous ARIC visit or participant required a proxy to assist with completing informed consent and responding to questions at ARIC Visit 6 or 7.
  • Vision impairment (worse than 20/63 on Minnesota (MN) Near Vision Card). Participants who cannot see (with correction) well enough to complete the neurocognitive assessment are excluded.
  • Medical contraindication to use of hearing aids (e.g., draining ear). Because hearing aids will be the primary device used in the hearing intervention, participants with medical contraindications to hearing aid use are excluded.
  • Conductive hearing impairment as determined by a difference in air audiometry and bone audiometry ("air-bone gap") greater than 15 dB in 2 or more contiguous frequencies in both ears. Because the impact of a conductive (versus a sensorineural) hearing loss on cognitive functioning may potentially differ and programming for hearing aids differs for conductive hearing loss, participants with permanent conductive hearing loss are excluded from the trial. Participants with an air-bone gap due to fluid in the ears or other resolvable medical issue may be enrolled in the trial following successful medical resolution of the cause of the air-bone gap.
  • Unwilling to wear hearing aids on a regular (i.e., daily or near daily) basis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years to 84 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Adele M Goman, PhD 443-287-7195 agoman1@jhmi.edu
Contact: Frank R Lin, MD, PhD 410-502-0150 flin1@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03243422
Other Study ID Numbers  ICMJE Not yet assigned
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins Bloomberg School of Public Health
Study Sponsor  ICMJE Johns Hopkins Bloomberg School of Public Health
Collaborators  ICMJE
  • University of North Carolina
  • University of South Florida
  • University of Pittsburgh
  • University of Mississippi Medical Center
  • Wake Forest University
  • University of Minnesota - Clinical and Translational Science Institute
Investigators  ICMJE
Principal Investigator: Frank R Lin, MD, PhD Johns Hopkins University
Principal Investigator: Josef Coresh Johns Hopkins University
PRS Account Johns Hopkins Bloomberg School of Public Health
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP