Hears-nps：聴覚障害に対処する神経精神症状の一般的な満たされていない貢献者として対処する (HEARS-NPS)
神経精神症状と難聴を聞く：神経精神症状の一般的な満たされていない貢献者としての難聴に対処する
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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Jami Trumbo, MSPH
- メール：jami.trumbo@jhu.edu
研究連絡先のバックアップ
- 名前：Esther Oh, MD, Ph.D.
- 電話番号：410-550-0925
- メール：eoh9@jhmi.edu
研究場所
-
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Maryland
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Baltimore、Maryland、アメリカ、21224
- 募集
- Johns Hopkins Memory and Alzheimer's Treatment Center
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コンタクト：
- Esther Oh, MD, PhD
- 電話番号：410-550-0925
- メール：eoh9@jhmi.edu
-
コンタクト：
- Peter Hope, BA
- 電話番号：410-550-9047
- メール：phope3@jh.edu
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主任研究者：
- Esther Oh, MD, PhD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：即時治療
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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. |
|
プラセボコンパレーター：遅延治療
|
Tailored fitting and programming of a personal sound amplifier accompanied by an aural rehabilitation component. Tailored aural rehabilitation for participant and care partner. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Distress as assessed by the Neuropsychiatric Inventory (NPI-Q)
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Hearing Handicap Inventory for the Elderly (HHIE-S)
時間枠：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)
時間枠：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)
|
|
International Outcome Inventory for Hearing Aids (IOI-HA) Survey
時間枠：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 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)
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Esther Oh, MD, PhD、Johns Hopkins University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IRB00357244
- 5R01AG076525-02 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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