ACHIEVE Brain Health Follow-Up Study
A legfontosabb adatok
- Ki végzi
- Johns Hopkins University
- Hol
- Hagerstown, Jackson, Minneapolis és Winston-Salem (Egyesült Államok)Mind a 4 helyszín megnézése
- Azonosító
- Állapot
- Fut, nem toboroz
- Fázis
- 3. fázis
- Résztvevők
- 629 fő vett részt
- Kezdés
- 2023. jan. 12.
- Várható befejezés
- 2027. máj. 31.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- Hearing intervention
- Successful aging/delayed hearing intervention
- A regiszteradat frissítve
- 2026. július 21.
Ki vehet részt
- Életkor
- 73 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 15 feltétel megnézéseKevesebb
Egyéb feltételek
- To be eligible for ACHIEVE-BHFU, participants must meet the following criteria:
- Eligible for and participated in the ACHIEVE trial (see original criteria below)
- Agree to participate and are able and willing to comply with study procedures for three years in the follow-up study; Original ACHIEVE Inclusion Criteria (during 2018-2019 enrollment):
- Age 70-84 years
- Community dwelling, fluent English speaker
- Availability of participant in area for study duration
- Adult-onset hearing impairment, defined as four-frequency pure tone average (PTA, 0.5-4 kilohertz (kHz), better ear) ≥ 30 decibels hearing level (dB HL) \& ≤ 70 dB HL
- Speech recognition scores in quiet ≥ 60% in better ear
- Mini-Mental State Exam (MMSE) score ≥ 23 for high school degree or less; ≥ 25 for some college or more; Original ACHIEVE Exclusion Criteria:
- Reported disability in ≥ 2 activities of daily living (ADLs)
- Vision impairment (worse than 20/63 on the Minnesota Near Vision Card)
- Self-reported use of a hearing aid in the past 1 year
- Medical contraindication to use of hearing aids (e.g., draining ear)
- Unwilling to wear hearing aids on a daily basis
- Conductive hearing impairment with air-bone gap > 15 dB (decibels) in two or more contiguous frequencies in both ears
Helyszínek itt: Egyesült Államok
- Johns Hopkins Comstock Center for Public Health Research and PreventionHagerstown, Egyesült ÁllamokNo longer taking part
- University of Mississippi Medical CenterJackson, Egyesült ÁllamokNo longer taking part
- University of MinnesotaMinneapolis, Egyesült ÁllamokNo longer taking part
- Wake Forest UniversityWinston-Salem, Egyesült ÁllamokNo longer taking part
A vizsgálatról
Mit akar kideríteni a vizsgálat
The ACHIEVE Brain Health Follow-Up Study is a 3-year follow-up to the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) randomized study to determine the long-term effect of hearing intervention vs. successful aging/delayed hearing intervention on rates of cognitive decline and incident mild cognitive impairment or dementia.
A vizsgálat 2 csoportja
- Hearing intervention (HI) groupMár használt kezelés, összehasonlításként
Participants in this group were randomized to the hearing intervention (HI) group at ACHIEVE trial baseline and received a best practices hearing rehabilitation treatment program, consisting of fitting with hearing aids and other hearing assistive technologies along with comprehensive, individualized hearing rehabilitation sessions with a study audiologist spaced over the 2-3 months post-fitting designed to provide all the active components of the intervention. Participants also received semi-annual booster sessions with the study audiologist. These participants will continue to receive hearing healthcare from the study audiologist and complete semi-annual sessions for 3 additional years.
Kezelés: Hearing intervention
- Successful aging/Delayed hearing intervention (SA/DHI) groupMár használt kezelés, összehasonlításként
Participants in this active control group were randomized to the successful aging (SA) group at ACHIEVE trial baseline and received a successful aging health education program, following the protocol and materials developed for the 10 Keys to Healthy Aging program. The program involved individualized sessions with a study health educator to control for staff-participant time and attention between the two groups. Upon completion of the ACHIEVE trial, these participants are offered the best practices hearing rehabilitative treatment program with comprehensive, individualized sessions post-fitting and will receive semi-annual booster sessions with the study audiologist for 3 years.
Kezelés: Successful aging/delayed hearing intervention
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Long-term Effects of Hearing Intervention on Brain Health in the Aging and Cognitive Health Evaluation in Elders Randomized Study
- A regiszteradat frissítve
- 2026. július 21.