<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03243422</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00008129</org_study_id>
    <secondary_id>R01AG055426</secondary_id>
    <nct_id>NCT03243422</nct_id>
  </id_info>
  <brief_title>Aging and Cognitive Health Evaluation in Elders (ACHIEVE)</brief_title>
  <acronym>ACHIEVE</acronym>
  <official_title>Aging and Cognitive Health Evaluation in Elders (ACHIEVE) Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins Bloomberg School of Public Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of North Carolina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of South Florida</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Mississippi Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wake Forest University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins Bloomberg School of Public Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The ACHIEVE study will be a randomized controlled trial nested within the infrastructure of&#xD;
      the Atherosclerosis Risk in Communities (ARIC) study. We plan to enroll 850 70-84 year-old&#xD;
      cognitively normal older adults with hearing loss, who will be randomized 1:1 to the hearing&#xD;
      intervention (hearing needs assessment, fitting of hearing devices, education/counseling) or&#xD;
      successful aging health education intervention (individual sessions with a health educator&#xD;
      covering healthy aging topics). Post-baseline, participants will be followed semi-annually&#xD;
      for 3 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ACHIEVE study will be a randomized controlled trial nested within the infrastructure of&#xD;
      the Atherosclerosis Risk in Communities (ARIC) study. We plan to enroll 850 70-84 year-old&#xD;
      cognitively normal older adults with hearing loss, who will be randomized 1:1 to the hearing&#xD;
      intervention (hearing needs assessment, fitting of hearing devices, education/counseling) or&#xD;
      successful aging health education intervention (individual sessions with a health educator&#xD;
      covering healthy aging topics). Post-baseline, participants will be followed semi-annually&#xD;
      for 3 years.&#xD;
&#xD;
      Outcomes will include assessments of cognition, social functioning, physical functioning, and&#xD;
      quality of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 4, 2018</start_date>
  <completion_date type="Actual">June 12, 2023</completion_date>
  <primary_completion_date type="Actual">November 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in global cognitive function</measure>
    <time_frame>3 years</time_frame>
    <description>Change from baseline to year 3 in global cognitive function, as assessed using a factor score derived from completion of a neurocognitive testing battery. The ACHIEVE study administers a neurocognitive testing battery annually, which includes the following cognitive tests: Delayed Word Recall, Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Word List, Incidental Learning, Logical Memory I and II, Word Fluency, Animal Naming, Boston Naming, Trail Making Test A and B, Digit Span Backwards, and Digit Symbol Substitution. Factor analytic methods use all items from all tests in the battery to generate a single score of global cognitive function.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time until cognitive impairment</measure>
    <time_frame>3 years</time_frame>
    <description>Time until cognitive impairment, defined as a composite outcome of (1) adjudicated diagnosis of dementia or mild cognitive impairment (MCI), (2) 3-point drop in the 30-item Mini-Mental State Exam (MMSE) administered in-person, or (3) a 3-point drop in a factor score derived from the 10-item MMSE orientation subscale and 11-item Blessed scale administered over the telephone and rescaled to be equivalent to the 30-item MMSE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cognition memory domain</measure>
    <time_frame>3 years</time_frame>
    <description>Change from baseline to year 3 in the cognition memory domain, as assessed using a memory domain factor score derived from completion of a neurocognitive testing battery. The cognitive tests for the memory domain include Delayed Word Recall, CERAD Word List, Incidental Learning, and Logical Memory I and II. These tests have an underlying commonality, or factor, that is unable to be directly measured, and factor analytic methods use items from the tests noted to generate a single overall memory score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cognition executive function domain</measure>
    <time_frame>3 years</time_frame>
    <description>Change from baseline to year 3 in the cognition executive function domain, as assessed using an executive function domain factor score derived from completion of a neurocognitive testing battery. The cognitive tests for the executive function domain include Trail Making Test A and B and Digit Symbol Substitution. These tests have an underlying commonality, or factor, that is unable to be directly measured, and factor analytic methods use items from the tests noted to generate a single overall executive function score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cognition language domain</measure>
    <time_frame>3 years</time_frame>
    <description>Change from baseline to year 3 in the cognition language domain, as assessed using a language domain factor score derived from completion of a neurocognitive testing battery. The cognitive tests for the language domain include Word Fluency, Animal Naming, and Boston Naming. These tests have an underlying commonality, or factor, that is unable to be directly measured, and factor analytic methods use items from the tests noted to generate a single overall language score.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Social engagement</measure>
    <time_frame>3 years</time_frame>
    <description>Change from baseline to year 3 in social engagement, as assessed by the Cohen's Social Network Index (SNI) questionnaire, which asks about the number of people the participant has regular contact with (at least once every 2 weeks) within each of 12 different possible settings/types of contacts (e.g., relatives, church members, neighbors, etc.). Social engagement is quantified by evaluating the total number of people in the social network across all 12 settings/roles.</description>
  </other_outcome>
  <other_outcome>
    <measure>Loneliness</measure>
    <time_frame>3 years</time_frame>
    <description>Change from baseline to year 3 in loneliness, as assessed using the University of California Los Angeles (UCLA) Loneliness Scale questionnaire. The UCLA Loneliness Scale is interviewer administered and consists of 20 items that participants rate using a 4-point Likert scale; 9 positively worded items are reverse-coded, and the average scores range from 1 to 4, with higher score indicating greater expression of loneliness.</description>
  </other_outcome>
  <other_outcome>
    <measure>Physical function: Lower extremity function</measure>
    <time_frame>3 years</time_frame>
    <description>Change from baseline to year 3 in lower extremity function, as assessed using the Short Physical Performance Battery (SPPB), which includes timed tests for usual gait speed, balance, and the ability to rise from a chair. Each of the 3 tests is scored from 0 to 4, with higher scores reflecting better lower extremity physical performance, and the total SPPB score is calculated as the sum of the 3 tests, with a range of 0 to 12, with higher scores reflecting better physical performance.</description>
  </other_outcome>
  <other_outcome>
    <measure>Physical function: Grip strength</measure>
    <time_frame>3 years</time_frame>
    <description>Change from baseline to year 3 in grip strength (kilograms of force) measured by a hand-held dynamometer, based on the best of two trials with the participant's preferred or best hand.</description>
  </other_outcome>
  <other_outcome>
    <measure>Physical function: Physical Activity</measure>
    <time_frame>3 years</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Self-reported physical ability</measure>
    <time_frame>3 years</time_frame>
    <description>Change from baseline to year 3 measured using the falls and mobility questionnaire which records living circumstances, self-reported physical ability, fatigue, and falls.</description>
  </other_outcome>
  <other_outcome>
    <measure>Self-reported physical activity</measure>
    <time_frame>3 years</time_frame>
    <description>Change from baseline to year 3 in self-reported physical activity measured using the Baecke Physical Activity Questionnaire, which includes questions about frequency of exercise/sports and leisure activities to generate composite scores of sports during leisure time (continuous measure between 1 and 5) and leisure time excluding sports (continuous measure between 1 and 5).</description>
  </other_outcome>
  <other_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>3 years</time_frame>
    <description>Change from baseline to year 3 in depressive symptoms, as assessed by the Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is an interviewer-administered scale that consists of 12 items which participants rate using a 3-point Likert scale; 2 positively worded items are reverse-coded. The first 11 items are summed to create a total score ranging from 0 to 22, with higher scores indicating greater expression of depression. The 12th item is a rating of hopelessness that is not included in the total score.</description>
  </other_outcome>
  <other_outcome>
    <measure>Hearing handicap</measure>
    <time_frame>3 years</time_frame>
    <description>Change from baseline to year 3 measured on the Hearing Handicap for the Elderly Screening Version (HHIE-S) questionnaire, which is a 10-item questionnaire developed to assess how an individual perceives the social and emotional effects of hearing loss; scores range from 0 to 40, with higher scores suggestive of greater hearing handicap</description>
  </other_outcome>
  <other_outcome>
    <measure>Hospitalizations</measure>
    <time_frame>3 years</time_frame>
    <description>Number of hospitalizations (all cause) over the course of follow-up based on self-report</description>
  </other_outcome>
  <other_outcome>
    <measure>Intervention feedback</measure>
    <time_frame>Gathered at 6 months post-baseline and 36 months post-baseline</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Physical health</measure>
    <time_frame>3 years</time_frame>
    <description>Change from baseline to year 3 as assessed using the RAND-36, which is an interviewer-administered scale measuring a person's perceptions of their health and health-related quality of life; the physical component score is an algorithmically derived score with a normative mean of 50 and standard deviation of 10 (range 0 to 100), where higher scores indicate better physical health.</description>
  </other_outcome>
  <other_outcome>
    <measure>Mental health</measure>
    <time_frame>3 years</time_frame>
    <description>Change from baseline to year 3 as assessed using the RAND-36, which is an interviewer-administered scale measuring a person's perceptions of their health and health-related quality of life; the mental component score is an algorithmically derived score with a normative mean of 50 and standard deviation of 10 (range 0 to 100), where higher scores indicate better mental health.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">977</enrollment>
  <condition>Aging</condition>
  <condition>Cognitive Decline</condition>
  <arm_group>
    <arm_group_label>Successful aging health education intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Individual sessions on healthy aging topics</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hearing intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Best practices hearing rehabilitative treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Successful aging health education intervention</intervention_name>
    <description>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 &quot;Key&quot;. 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.</description>
    <arm_group_label>Successful aging health education intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hearing intervention</intervention_name>
    <description>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.</description>
    <arm_group_label>Hearing intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 70-84 years. Individuals aged 70-84 at the time of randomization are eligible for&#xD;
             participation. This age range will allow recruitment of participants who are at risk&#xD;
             for cognitive decline but who may also be expected to survive for the duration of the&#xD;
             trial. This age range is estimated to allow for potential participation of 61% of&#xD;
             participants currently enrolled in the ARIC study.&#xD;
&#xD;
          -  Community-dwelling.&#xD;
&#xD;
          -  Fluent English-speaker.&#xD;
&#xD;
          -  Residency. Participants must plan to reside in the local area for the study duration.&#xD;
&#xD;
          -  Audiometric hearing impairment. Participants must have adult-onset hearing impairment&#xD;
             with a four-frequency pure tone average (0.5, 1, 2, 4 kHz) in the better-hearing ear&#xD;
             of ≥ 30 decibels (dB) and &lt;70 dB. This level of hearing impairment is the level at&#xD;
             which individuals would be most likely to benefit from the use of conventional&#xD;
             amplification devices such as hearing aids.&#xD;
&#xD;
          -  Word Recognition in Quiet score ≥60% in the better ear. A word recognition in quiet&#xD;
             score &lt;60% suggests hearing impairment that is too severe to benefit from conventional&#xD;
             amplification devices such as hearing aids.&#xD;
&#xD;
          -  Mini-Mental State Exam (MMSE) score ≥ 23 for individuals with high-school degree or&#xD;
             less; Mini-Mental State Exam (MMSE) score ≥ 25 for individuals with some college or&#xD;
             more; Participants must be at risk for cognitive decline in the range quantified well&#xD;
             by neurocognitive testing, and so must be free from more substantial cognitive&#xD;
             impairment at baseline.&#xD;
&#xD;
          -  Willingness to participate be randomized and adhere to the protocol. Participants must&#xD;
             be willing and able to consent to participate in the study, be willing to be&#xD;
             randomized to either the Hearing intervention or to the Successful Aging intervention,&#xD;
             and be willing to commit to adhere to the study protocol for the duration of the trial&#xD;
             (3 years of a randomly assigned intervention).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Self-reported disability in ≥ 2 or more Activities of Daily Living (ADL).&#xD;
&#xD;
          -  Any self-reported hearing aid use in the past year. Trial participants will be&#xD;
             randomized to hearing intervention or successful aging intervention and, therefore,&#xD;
             participants cannot be receiving treatment for their hearing loss already.&#xD;
&#xD;
          -  ARIC participants only: Diagnosis of adjudicated dementia based on a previous ARIC&#xD;
             visit or participant required a proxy to assist with completing informed consent and&#xD;
             responding to questions at ARIC Visit 6 or 7.&#xD;
&#xD;
          -  Vision impairment (worse than 20/63 on MNREAD Acuity Chart). Participants who cannot&#xD;
             see (with correction) well enough to complete the neurocognitive assessment are&#xD;
             excluded.&#xD;
&#xD;
          -  Medical contraindication to use of hearing aids (e.g., draining ear). Because hearing&#xD;
             aids will be the primary device used in the hearing intervention, participants with&#xD;
             medical contraindications to hearing aid use are excluded.&#xD;
&#xD;
          -  Permanent conductive hearing impairment as determined by a difference in air&#xD;
             audiometry and bone audiometry (&quot;air-bone gap&quot;) greater than 15 dB in 2 or more&#xD;
             contiguous frequencies in both ears. Because the impact of a conductive (versus a&#xD;
             sensorineural) hearing loss on cognitive functioning may potentially differ and&#xD;
             programming for hearing aids differs for conductive hearing loss, participants with&#xD;
             permanent conductive hearing loss are excluded from the trial. Participants with an&#xD;
             air-bone gap due to fluid in the ears or other resolvable medical issue may be&#xD;
             enrolled in the trial following successful medical resolution of the cause of the&#xD;
             air-bone gap.&#xD;
&#xD;
          -  Unwilling to wear hearing aids on a regular (i.e., daily or near daily) basis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>84 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frank R Lin, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Josef Coresh</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Comstock Center for Public Health Research</name>
      <address>
        <city>Hagerstown</city>
        <state>Maryland</state>
        <zip>21740</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest University</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>June 15, 2023</last_update_submitted>
  <last_update_submitted_qc>June 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 23, 2023</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT03243422/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 23, 2023</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT03243422/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03243422
org study id: IRB00008129
secondary id: R01AG055426
nct id: NCT03243422
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in global cognitive function
time frame: 3 years
description: Change from baseline to year 3 in global cognitive function, as assessed using a factor score derived from completion of a neurocognitive testing battery. The ACHIEVE study administers a neurocognitive testing battery annually, which includes the following cognitive tests: Delayed Word Recall, Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Word List, Incidental Learning, Logical Memory I and II, Word Fluency, Animal Naming, Boston Naming, Trail Making Test A and B, Digit Span Backwards, and Digit Symbol Substitution. Factor analytic methods use all items from all tests in the battery to generate a single score of global cognitive function.
measure: Time until cognitive impairment
time frame: 3 years
description: Time until cognitive impairment, defined as a composite outcome of (1) adjudicated diagnosis of dementia or mild cognitive impairment (MCI), (2) 3-point drop in the 30-item Mini-Mental State Exam (MMSE) administered in-person, or (3) a 3-point drop in a factor score derived from the 10-item MMSE orientation subscale and 11-item Blessed scale administered over the telephone and rescaled to be equivalent to the 30-item MMSE.
measure: Change in cognition memory domain
time frame: 3 years
description: Change from baseline to year 3 in the cognition memory domain, as assessed using a memory domain factor score derived from completion of a neurocognitive testing battery. The cognitive tests for the memory domain include Delayed Word Recall, CERAD Word List, Incidental Learning, and Logical Memory I and II. These tests have an underlying commonality, or factor, that is unable to be directly measured, and factor analytic methods use items from the tests noted to generate a single overall memory score.
measure: Change in cognition executive function domain
time frame: 3 years
description: Change from baseline to year 3 in the cognition executive function domain, as assessed using an executive function domain factor score derived from completion of a neurocognitive testing battery. The cognitive tests for the executive function domain include Trail Making Test A and B and Digit Symbol Substitution. These tests have an underlying commonality, or factor, that is unable to be directly measured, and factor analytic methods use items from the tests noted to generate a single overall executive function score.
measure: Change in cognition language domain
time frame: 3 years
description: Change from baseline to year 3 in the cognition language domain, as assessed using a language domain factor score derived from completion of a neurocognitive testing battery. The cognitive tests for the language domain include Word Fluency, Animal Naming, and Boston Naming. These tests have an underlying commonality, or factor, that is unable to be directly measured, and factor analytic methods use items from the tests noted to generate a single overall language score.
measure: Social engagement
time frame: 3 years
description: Change from baseline to year 3 in social engagement, as assessed by the Cohen's Social Network Index (SNI) questionnaire, which asks about the number of people the participant has regular contact with (at least once every 2 weeks) within each of 12 different possible settings/types of contacts (e.g., relatives, church members, neighbors, etc.). Social engagement is quantified by evaluating the total number of people in the social network across all 12 settings/roles.
measure: Loneliness
time frame: 3 years
description: Change from baseline to year 3 in loneliness, as assessed using the University of California Los Angeles (UCLA) Loneliness Scale questionnaire. The UCLA Loneliness Scale is interviewer administered and consists of 20 items that participants rate using a 4-point Likert scale; 9 positively worded items are reverse-coded, and the average scores range from 1 to 4, with higher score indicating greater expression of loneliness.
measure: Physical function: Lower extremity function
time frame: 3 years
description: Change from baseline to year 3 in lower extremity function, as assessed using the Short Physical Performance Battery (SPPB), which includes timed tests for usual gait speed, balance, and the ability to rise from a chair. Each of the 3 tests is scored from 0 to 4, with higher scores reflecting better lower extremity physical performance, and the total SPPB score is calculated as the sum of the 3 tests, with a range of 0 to 12, with higher scores reflecting better physical performance.
measure: Physical function: Grip strength
time frame: 3 years
description: Change from baseline to year 3 in grip strength (kilograms of force) measured by a hand-held dynamometer, based on the best of two trials with the participant's preferred or best hand.
measure: Physical function: Physical Activity
time frame: 3 years
description: 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.
measure: Self-reported physical ability
time frame: 3 years
description: Change from baseline to year 3 measured using the falls and mobility questionnaire which records living circumstances, self-reported physical ability, fatigue, and falls.
measure: Self-reported physical activity
time frame: 3 years
description: Change from baseline to year 3 in self-reported physical activity measured using the Baecke Physical Activity Questionnaire, which includes questions about frequency of exercise/sports and leisure activities to generate composite scores of sports during leisure time (continuous measure between 1 and 5) and leisure time excluding sports (continuous measure between 1 and 5).
measure: Depressive symptoms
time frame: 3 years
description: Change from baseline to year 3 in depressive symptoms, as assessed by the Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is an interviewer-administered scale that consists of 12 items which participants rate using a 3-point Likert scale; 2 positively worded items are reverse-coded. The first 11 items are summed to create a total score ranging from 0 to 22, with higher scores indicating greater expression of depression. The 12th item is a rating of hopelessness that is not included in the total score.
measure: Hearing handicap
time frame: 3 years
description: Change from baseline to year 3 measured on the Hearing Handicap for the Elderly Screening Version (HHIE-S) questionnaire, which is a 10-item questionnaire developed to assess how an individual perceives the social and emotional effects of hearing loss; scores range from 0 to 40, with higher scores suggestive of greater hearing handicap
measure: Hospitalizations
time frame: 3 years
description: Number of hospitalizations (all cause) over the course of follow-up based on self-report
measure: Intervention feedback
time frame: Gathered at 6 months post-baseline and 36 months post-baseline
description: 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.
measure: Physical health
time frame: 3 years
description: Change from baseline to year 3 as assessed using the RAND-36, which is an interviewer-administered scale measuring a person's perceptions of their health and health-related quality of life; the physical component score is an algorithmically derived score with a normative mean of 50 and standard deviation of 10 (range 0 to 100), where higher scores indicate better physical health.
measure: Mental health
time frame: 3 years
description: Change from baseline to year 3 as assessed using the RAND-36, which is an interviewer-administered scale measuring a person's perceptions of their health and health-related quality of life; the mental component score is an algorithmically derived score with a normative mean of 50 and standard deviation of 10 (range 0 to 100), where higher scores indicate better mental health.
arm group label: Successful aging health education intervention
arm group type: Active Comparator
description: Individual sessions on healthy aging topics
arm group label: Hearing intervention
arm group type: Active Comparator
description: Best practices hearing rehabilitative treatment
intervention type: Other
intervention name: Successful aging health education intervention
description: 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.
arm group label: Successful aging health education intervention
intervention type: Other
intervention name: Hearing intervention
description: 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.
arm group label: Hearing intervention
criteria: 
gender: All
minimum age: 70 Years
maximum age: 84 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Frank R Lin, MD, PhD
role: Principal Investigator
affiliation: Johns Hopkins University
last name: Josef Coresh
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cognitive Dysfunction
provided document: 
provided document: 