Hør-NP'er: Adressering af høretab som en almindelig uopfyldt bidragyder af neuropsykiatriske symptomer (HEARS-NPS)
Hører neuropsykiatriske symptomer og høretab: Adressering af høretab som en almindelig uopfyldt bidragyder af neuropsykiatriske 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Jami Trumbo, MSPH
- E-mail: jami.trumbo@jhu.edu
Undersøgelse Kontakt Backup
- Navn: Esther Oh, MD, Ph.D.
- Telefonnummer: 410-550-0925
- E-mail: eoh9@jhmi.edu
Studiesteder
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Maryland
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Baltimore, Maryland, Forenede Stater, 21224
- Rekruttering
- Johns Hopkins Memory and Alzheimer's Treatment Center
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Kontakt:
- Esther Oh, MD, PhD
- Telefonnummer: 410-550-0925
- E-mail: eoh9@jhmi.edu
-
Kontakt:
- Peter Hope, BA
- Telefonnummer: 410-550-9047
- E-mail: phope3@jh.edu
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Ledende efterforsker:
- Esther Oh, MD, PhD
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Øjeblikkelig 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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)
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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 |
Foranstaltningsbeskrivelse |
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)
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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)
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Esther Oh, MD, PhD, Johns Hopkins University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neurologiske manifestationer
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Psykiske lidelser
- Neurokognitive lidelser
- Kognitionsforstyrrelser
- Tauopatier
- Neurodegenerative sygdomme
- Otorhinolaryngologiske sygdomme
- Sensationsforstyrrelser
- Øresygdomme
- Hørelidelser
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Kognitiv dysfunktion
- Alzheimers sygdom
- Demens
- Høretab
Andre undersøgelses-id-numre
- IRB00357244
- 5R01AG076525-02 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
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