ACHIEVE Randomized Controlled Trial

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ACHIEVE Randomized Controlled Trial(Aging, Cognition, and Hearing Evaluation in Elders)A Randomized Controlled Trial to Determine if Hearing Loss Treatment Reduces the Risk of Cognitive Decline & Dementia in Older Adults2017-2021

Co-PIsFrank R. Lin, MD PhD Josef Coresh, MD PhD

ACHIEVEGrant Review and Funding Timeline

ACHIEVE R01 (total funds requested: $15.9M) submitted in June 2016 in response

to NIA program announcement

for Phase III RCTs for age-related cognitive decline & dementia. Grant start date of April 1.

ACHIEVE RCT reviewed by NIA SEP on 10/13/2016. Score of 28 with reviewer concerns focused on analytic plan.

ACHIEVE reviewed by Council and internally by NIA and is

high on the list of studies to be funded. They’ll forward part of the list for

funding within the next 2-3 weeks;

another list will go when the $

400M

for AD is known later

at end of April. We don’t

know exactly where we are on the

list,

but it looks like we’ll get funded sometime this spring to summer

. In the meantime, ACHIEVE resubmission addressing issues related to analytic plan was just submitted on March 3 (funding start 9/1).

ACHIEVEProjected Timeline

Design: April 2017 – Sept 2017 (assuming funding on this cycle)

Finalize protocol, MOP, CRFs;

e

stablish DSMB

Staff training (Univ. S. Florida investigators will work with field sites to identify study audiologist for each site)

Recruitment: Oct 2017- March 2019 (18 months)

Recruitment of ARIC NCS & de novo participants (recruitment goal:

n = 850, randomize ~3/week/site

)

From ARIC-NCS ~400-450: ~600 from V6 projected to meet study inclusion criteria * ~69% of eligible ARIC participants in the ACHIEVE pilot joined the study

V6 hearing/cognition assessment establishes eligibility

V7 & baseline ACHIEVE visit include many of the same elements (~1.5

hrs

of testing needed for ACHIEVE on top of V7)

Follow-up: April 2019 – March 2022

Projected ACHIEVE Eligible from Interim

Asessment

of V6 data (N = 924)

ACHIEVE

Study Visits & Eligibility Criteria

Each ACHIEVE participant will have up to 12 study visitsScreening visit (SV) (<1 hr; incorporated with V6/V7)Baseline visit (BV) & randomization (3 hrs; In ARIC ~1.5 hours on top of V7)Treatment intervention visits (~ 1 hour visits x 4, interspersed over 3 months post-randomization)Semiannual visits from 6-36 months post-randomization (~1-3 hours depending on visit).

Inclusion CriteriaExclusion CriteriaAge 70-84 yearsReported disability in ≥ 2 Activities of Daily Living (ADL)Community-dwelling, Fluent English-speakerVision impairment (worse than 20/40 on MN Near Vision Card)Availability of participant in area for study durationSelf-reported use of a hearing aid in the past 1 yearPTA (0.5-2kHz, better ear) ≥ 30 dB & <70 dB; adult-onset Medical contraindication to use of hearing aids (e.g., draining ear)Speech recognition scores >60% bilaterallyUnwilling to wear hearing aids on daily basisMMSE ≥ 23 for high school degree or less; ≥ 25 for some college or moreConductive hearing impairment with air-bone gap >15 db in 2 or more contiguous frequencies in both ears

ACHIEVE Eligibility Criteria

* Included in V6 & V7

Run-in

*

*

*

*

*

* Included in V7

ACHIEVESpeech Understanding Protocol for ACHIEVE Neurocog Asessment

The ACHIEVE neurocog assessment is preceded by a brief protocol (takes <5 min) to ensure/document that HL & spoken language understanding are not confounding neurocog assessment. The test comprises 5 sentences (3 key words/sentence) that the technician reads, and the ppt is asked to repeat back each sentence. Ppt scored as #words correctly repeated out of 15. We could consider administering this protocol to all NCS (not just ACHIEVE) participants undergoing cognitive testing. This protocol does not change any current procedures for NCS cog testing. It just documents and ensures that HL & speech understanding is not confounding performance.

ACHIEVEPossible Recruitment Scenarios For ARIC-NCS Participants

V6 – September/October to December 2017

Concurrent V6

&

ACHIEVE BL

Screening

phone

call

before visit about

ACHIEVE

V6

data as ACHIEVE

SV

All

shared V6 & ACHIEVE outcomes used as ACHIEVE BL (

neurocog

assessment performed with speech understanding protocol)

ACHIEVE BV (~1.5

hrs

) for ACHIEVE-specific outcomes layered on top of V6

at

same visit or separate visit, consent, randomization

If ≤ 2 months from V6 to ACHIEVE BL

V6 data as ACHIEVE SV + screening phone call to ensure eligibility/interest

V6 data on all outcomes shared between V6 and ACHIEVE can be used as ACHIEVE BV data

ACHIEVE BV (~1.5-2

hrs

) – other ACHIEVE-specific measures (comprehensive audiometry, etc.), consent, randomization

If > 2 months from V6 to ACHIEVE BL

V6 data as ACHIEVE SV + screening phone call to ensure eligibility/interest

ACHIEVE BV (3 hours) – all ACHIEVE BV outcomes, consent, randomization

NCS participants recruited at V6 would have V7 visits timed with an ACHIEVE annual f/u visit

ACHIEVEPossible Recruitment Scenarios For ARIC-NCS Participants

V7 – January 2018 to March 2019

Concurrent

V7 &

ACHIEVE

BL

V6 data to identify participants who are likely eligible for ACHIEVE + screening phone call to ensure eligibility/interest

Abbreviated audiometric protocol in V7 for subset of NCS

partcipants

who would be ACHIEVE eligible. Data used for audiometric screening to ensure eligibility.

All

shared

V7

& ACHIEVE outcomes used as ACHIEVE BL (

neurocog

assessment performed with speech understanding protocol)

ACHIEVE BV (~1.5

hrs

) for ACHIEVE-specific outcomes layered on top of V6

at

same visit or separate visit, consent, randomization

If ≤ 2 months from V7 to ACHIEVE BL

V7 data as ACHIEVE SV + screening phone call to ensure eligibility/interest

V7 data on all outcomes shared between V6 and ACHIEVE used as ACHIEVE BV

ACHIEVE BV (~1.5-2

hrs

) – other ACHIEVE-specific measures (comprehensive audiometry, etc.), consent, randomization

If > 2 months from V7 to ACHIEVE BL

V7 data as ACHIEVE SV + screening phone call to ensure eligibility/interest

ACHIEVE BV (3 hours) – all ACHIEVE BV outcomes, consent, randomization

ACHIEVEAudiometric Testing at V7

Presently at V6:

HNE – Hearing history form (< 3 min)

HHIE – Hearing handicap inventory (< 3 min)

AUD – Objective

audiologic

testing (~ 20 min)

Proposed for V7:

HNE – All participants - data on HA use, etc. needed for ACHIEVE screening; other data are needed for general analyses

HHIE – All participants - needed for continued analyses

AUD –

Limited

to the

~20% subset

of NCS participants who would likely be ACHIEVE eligible based on V6

data

L

imited audiometric battery restricted to data needed for ACHIEVE screening. Speech in noise testing dropped. Testing can be performed using the booth or the iPad audiometer.

Estimate ~ 5-7 minutes.

ACHIEVEProviding Hearing Results to NCS Participants at V6

Presently at V6:

Technicians instructed to print out audiogram that comes with brief explanatory blurb & give to

ppts

Not working that well.

Audiogram data is confusing & techs unaccustomed to immediately printing out a form to give to participants

Proposed change:

Report generated using data in CDART classifying hearing loss as normal/mild/moderate/severe with explanation.

Report sent to participant with other post-visit reports

Information also provided on ACHIEVE trial on the report

ACHIEVEProviding Hearing Results to NCS Participants at V6

Outline of auto-generated report using CDART data:

Your

recent hearing evaluation shows that you have

(AUTO FILL – Normal, Mild, Moderate, Severe or greater)

hearing loss. If you are concerned about your hearing loss and have additional questions, you can consider discussing these results with your primary care physician or an audiologist in your area.

(Auto Fill for Participants Identified with Mild or Moderate hearing loss: Your results from today’s evaluation suggest you may be eligible for a new ancillary study to ARIC called ACHIEVE (Aging, Cognition, & Hearing Evaluation in Elders Study). Participants in ACHIEVE will be randomly assigned to receive either personalized one-on-one healthy aging education sessions with a health educator or to receive hearing aids and training in their use. The study will last 3 years and all services will be provided free of charge. At the end of the study, ACHIEVE participants can also choose to receive the other intervention free of charge if they would like.

Session* (Timing post-randomization)Hearing Successful Aging#1 (Wk 1-3)Assessment of auditory needs, Hearing aid fittingOne-on-one session with health educator on key 1**#2 (Wk 3-5)HA adjustment, counselingKey 2#3 (Wk 6-8)Hearing counseling, fitting for other hearing technologiesKey 3#4 (Wk 8-10)Hearing counseling, Technology adjustmentsKey 4Booster Sessions(every 6 months post-randomization)Technology reinstruction & verificationKey or group session

* Sessions are ~ 1 hour** SA ppts select which “keys” to successful aging they wish to review/learn (e.g., maintaining healthy bones, physical activity, etc.)

ACHIEVE

Hearing Loss & Successful Aging Interventions