Comparative Effectiveness of Dementia Care Strategies in Underserved Communities
2015年5月6日 更新者：RAND
Dementia is a condition that is growing in prevalence and which harms not only the afflicted individual but also adversely affects the health of their family and other informal caregivers.
New methods for delivering comprehensive assistance to persons with dementia and their caregivers are known to be effective and can delay nursing home placement, but this study will discover 1) whether more face-to-face involvement rather than telephone delivery of this assistance will work better among poor patients in Los Angeles, and 2) if one method is better than the other, what are the differences in costs between them.
These data will enable administrators in public health care settings around the US and non-profit foundations addressing dementia patient and caregiver needs to decide what method provides the best value and the best outcome relative to its cost.
調査の概要
研究の種類
介入
入学 (実際)
144
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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Sylmar、California、アメリカ、91342-1495
- Olive View-UCLA Medical Center
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
21年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Caregivers of persons with dementia
- Caregivers must either live with the care recipient (person with dementia) or be the identified primary support
- Caregiver relationship must have been present for the prior 6 months
- Caregivers must have telephone access
- Caregivers must speak English or Spanish
- Care recipients must have a prior dementia diagnosis
- Care recipients must be living in the community other than a nursing facility
Exclusion Criteria:
- Persons with dementia, lacking an informal caregiver who can communicate in Spanish or English, or living in a long term care facility
- Caregiver lacks the capacity to consent to study participation
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Dementia care management in person
The dementia care management protocol will be delivered via face-to-face interactions in participants' homes or in mutually convenient locations between a trained care manager and the care recipient/informal family caregiver dyad, supplemented by telephone.
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Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues.
Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems.
An electronic tracking tool and resource manual guide delivery of the care management protocols.
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アクティブコンパレータ：Dementia care management telephone only
The dementia care management protocol will be delivered via telephonic meetings only.
Assessment, education, counseling, and social support procedures as well as referral and follow-ups will follow the same procedural content as stipulated for the face-to-face intervention, however, contact will not be planned in person.
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Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues.
Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems.
An electronic tracking tool and resource manual guide delivery of the care management protocols.
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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 |
|---|---|---|
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Change in Caregiver Burden at 6 and 12 Months
時間枠：0, 6 and 12 months
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The Zarit Burden Interview (BI) is a widely used validated measure to assess stressors experienced by caregivers of persons with dementia.
Originally a 29-item instrument, the 22-item modified version is easily completed by telephone.
This instrument covers five constructs of burden: health, psychological well-being, finances, social life, and relationship with impaired person and an overall summary score of caregiver burden.
Higher Zarit scores indicate greater caregiver burden.
The minimum possible score is 0, and the maximum possible score is 110.
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0, 6 and 12 months
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Change in Care Recipient Memory and Problem Behaviors at 6 and 12 Months
時間枠：0, 6 and 12 months
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The Revised Memory and Behavior Problem Checklist (RMBPC) was developed by Teri and colleagues.
The RMBPC instrument assess 24 care receiver problems in the areas of behavior, memory, and depression and whether each behavior had occurred in the prior week.
Higher RMBPC scores mean worse memory/behavior problems.
The minimum possible score for number of problems is zero, and the maximum score for number of problems is 24.
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0, 6 and 12 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Caregiver Depression at 6 and 12 Months
時間枠：0, 6 and 12 months
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The Patient Health Questionnaire - Nine (PHQ-9) is a 9-item self-report measure of depressive symptoms over the previous 2 weeks.
The PHQ-9 is the depression module of the PRIME- MD diagnostic instrument for common mental disorders.
It covers each of the 9 DSM-IV depression criteria scoring them as "0" (not at all) to "3" (nearly every day).
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0, 6 and 12 months
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Change in Caregiver Quality of Life at 6 and 12 Months
時間枠：0, 6 and 12 months
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The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia, incorporates non-health related issues as well as positive aspects of caregiving, and has demonstrated feasibility as a phone-based instrument in both English and Spanish.
Eighty items are distributed across 10 scales: assistance with ADLs, assistance with IADLs, personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving.
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0, 6 and 12 months
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Change in Care Recipient Quality of Life at 6 and 12 Months
時間枠：0, 6 and 12 months
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The investigators will evaluate patient health-related quality of life (HRQOL) by proxy (caregiver) assessment using the 15-item Health Utilities Index (HUI2), a generic health state classification system with preference-based utility weights derived from the general population.
The HUI is one of the more widely used utility measures and has been used in previous studies of elderly with dementia and their caregivers.
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0, 6 and 12 months
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Change in Process Measures of Dementia Care Quality at 6 and 12 Months
時間枠：0, 6 and 12 months
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The investigators will collect caregiver survey identified care process measures to assess which medical care processes that are specific to dementia occurred as a potential mediator of change in outcomes.
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0, 6 and 12 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
協力者
捜査官
- 主任研究者：Joshua Chodosh, M.D., MSHS、RAND
- 主任研究者：Barbara Vickrey, M.D., MPH、RAND
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年3月1日
一次修了 (実際)
2013年10月1日
研究の完了 (実際)
2013年10月1日
試験登録日
最初に提出
2011年1月18日
QC基準を満たした最初の提出物
2011年10月25日
最初の投稿 (見積もり)
2011年10月26日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年5月22日
QC基準を満たした最後の更新が送信されました
2015年5月6日
最終確認日
2015年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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