Hears-NPs: adressering av hørselstap som en vanlig uoppfylt bidragsyter av nevropsykiatriske symptomer (HEARS-NPS)
Hører nevropsykiatriske symptomer og hørselstap: adressering av hørselstap som en vanlig uoppfylt bidragsyter av nevropsykiatriske symptomer
This randomized controlled trial study aims to evaluate a revised hearing care intervention for older adults with Alzheimer's Disease and Related Dementias (ADRD). The community-delivered hearing care intervention utilizes tailored strategies to assess impact on communication, neuropsychiatric symptoms (NPS), and care partner distress.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Jami Trumbo, MSPH
- E-post: jami.trumbo@jhu.edu
Studer Kontakt Backup
- Navn: Esther Oh, MD, Ph.D.
- Telefonnummer: 410-550-0925
- E-post: eoh9@jhmi.edu
Studiesteder
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Maryland
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Baltimore, Maryland, Forente stater, 21224
- Rekruttering
- Johns Hopkins Memory and Alzheimer's Treatment Center
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Ta kontakt med:
- Esther Oh, MD, PhD
- Telefonnummer: 410-550-0925
- E-post: eoh9@jhmi.edu
-
Ta kontakt med:
- Peter Hope, BA
- Telefonnummer: 410-550-9047
- E-post: phope3@jh.edu
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Hovedetterforsker:
- Esther Oh, MD, PhD
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Age 60 - 100 years old
- English-speaking
- Diagnosis of probable Alzheimer's Disease or other related dementia according to the core clinical criteria outlined in the National Institute on Aging (NIA) and Alzheimer's Association Guidelines
- Speech frequency pure tone average (0.5- 4 kHz) >25 db in the better-hearing ear; adult onset hearing loss
- Availability of caregiver/study partner who is 18+ to participate in all study-related visits and who provides care supervision
- Stable (for 2 weeks or longer) dosing of medication (e.g. antidepressants, antipsychotics) for neuropsychiatric symptoms
Exclusion Criteria:
- Current self-reported use of hearing aid or amplification device
- Medical contraindication to use hearing aids ( e.g. draining ears)
- Inability to participate in the 1-month follow up
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Øyeblikkelig behandling
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Tailored fitting and programming of a personal sound amplifier accompanied by an aural rehabilitation component. Tailored aural rehabilitation for participant and care partner. |
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Placebo komparator: Forsinket behandling
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Tailored fitting and programming of a personal sound amplifier accompanied by an aural rehabilitation component. Tailored aural rehabilitation for participant and care partner. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Distress as assessed by the Neuropsychiatric Inventory (NPI-Q)
Tidsramme: Baseline, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months post-baseline (Delayed Group)
|
Scoring: Each of the 12 NPI-Q domains contains a survey question that reflects symptoms of that domain. Initial responses to each domain question are "Yes" or "No". If the response to the question is "No", the informant goes to the next question. If "Yes", the informant then rates both the Severity of the symptoms present within the last month on a 3-point scale and the associated impact of the symptom manifestations using a 5-point scale. The NPI-Q provides symptom Severity and Distress ratings for each symptom reported, and total Severity and Distress scores reflecting the sum of individual domain scores. Total NPI-Q severity score is the sum of individual symptom scores, ranges from 0 to 36. Higher score is worse SEVERITY of the symptom (how it affects the patient):
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Baseline, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months post-baseline (Delayed Group)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Hearing Handicap Inventory for the Elderly (HHIE-S)
Tidsramme: Baseline, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months post-baseline (Delayed Group)
|
Higher scores indicate increased hearing handicap. Scoring: 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap An increase in the score from baseline (a positive number) indicates a worsening in hearing handicap. |
Baseline, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months post-baseline (Delayed Group)
|
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Relationship Quality as assessed by the Patient-Caregiver Closeness Scale (CG-CR)
Tidsramme: Baseline, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months post-baseline (Delayed Group)
|
The scale assesses the closeness of the caregiver-care recipient relationship with six items. The total score ranges from 14 to 70. A higher total score reflects a better relationship quality. |
Baseline, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months post-baseline (Delayed Group)
|
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International Outcome Inventory for Hearing Aids (IOI-HA) Survey
Tidsramme: Baseline, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months post-baseline (Delayed Group)
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The hearing inventory survey is used to evaluate the effectiveness of alternative interventions such as assistive devices and communication strategies. The total score ranges from 7-35 where higher scores indicate a better outcome. |
Baseline, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months post-baseline (Delayed Group)
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Esther Oh, MD, PhD, Johns Hopkins University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Nevrologiske manifestasjoner
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Psykiske lidelser
- Nevrokognitive lidelser
- Kognisjonsforstyrrelser
- Tauopatier
- Nevrodegenerative sykdommer
- Otorhinolaryngologiske sykdommer
- Sensasjonsforstyrrelser
- Øresykdommer
- Hørselsforstyrrelser
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Kognitiv dysfunksjon
- Alzheimers sykdom
- Demens
- Hørselstap
Andre studie-ID-numre
- IRB00357244
- 5R01AG076525-02 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
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