German Adaptation of REACH II (GE-REACH)
2016年10月5日 更新者：Hermann-Josef Gertz、University of Leipzig
German Adaptation of Resources to Enhance Alzheimer's Caregiver Health
The purpose of the present study is to adapt, to implement and to evaluate an support program for family caregivers of patients suffering from Alzheimers'Disease (AD).
The intervention was comprehensive developed and successful evaluated in the USA and is called Resources to Enhance Alzheimers´Caregiver Health -second step (REACH II).
To test the effectiveness of this German adaptation of REACH II the present implementation study is designed as randomized and controlled trial.
Primary outcome is reducing family caregiver burden.
調査の概要
詳細な説明
Caring for elderly people with dementia imposes a heavy strain on care providers like family caregivers and puts them at risk of psychological and physical morbidity. A variety of psychosocial interventions have been developed which aim at improving caregiver emotional and physical health. These interventions differ in terms of treatment delivery (individual or group format) and content (education, symptom appraisal, problem solving, skill building, stress management or behavior modification). Systematic reviews and meta analyses have concluded that individualized programs have a greater impact than group interventions, and problem solving or behavior modification strategies are superior to education alone. Structured multi-component interventions may also reduce the risk of patients home admissions.
The intervention program "Resources to Enhance Alzheimer's Caregivers Health -second step" (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers and was successfully evaluated in a multisite, randomized and controlled trial in the USA. The overall objectives of REACH II are to identify and reduce modificable risk factors to enhance the well-being of the caregivers and to enhance the quality of care. It takes place at caregivers home and focuses on 5 domains that are important to caregivers: reducing depression, decreasing burden, improving self care, enhancing social support, and managing problem behaviours.
Since there is a lack of effective treatment programs for family caregivers of demented persons in the German Health system respectively care system the purpose of the present study is to adapt and to implement REACH II to the care system conditions of a medium-sized East German town (Leipzig). To test the effects of this adapted intervention program the present study is design as unisite, randomized and controlled trail. Primary outcome is reducing family caregiver burden.
研究の種類
介入
入学 (実際)
92
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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Saxonia
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Leipzig、Saxonia、ドイツ、04103
- Klinik und Poliklinik für Psychiatrie und Psychotherapie
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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
- 子
- 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
- age 21 years or older
- living with or sharing cooking facilities with the care recipient
- providing care for a relative with a medical diagnosed Alzheimer disease or related disorder, vascular dementia or behavior variant frontotemporal dementia for at least 4 hours per day for at least the past 6 months
Exclusion criteria
- Involvment in another caregiver intervention
- actual psychiatric diagnosis of mental illness
- illness that would prevent 6 months of study participation
- forthcoming institutionalization of the person being cared.
Other requirements were logistic, including having a telephone, planning to remain in the geographic area for at least 6 months, and competency in German.
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- 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 |
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実験的：GE-REACH-program
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The intervention program "Resources to Enhance Alzheimer's Caregivers Health -second step" (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers
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介入なし：対照群
普段のお手入れ
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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 From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 6
時間枠：baseline and month 6
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The ZBI is a validated , self-reported instrument assessing burden of caregivers of people with dementia over a undefined period of time.
Possible scores range from 0 (no burden) to 88 (highest possible burden).
Change = (month 6 - baseline score).
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baseline and month 6
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Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 9
時間枠：baseline and month 9
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The ZBI is a validated , self-reported instrument assessing burden of caregivers of people with dementia over a undefined period of time.
Possible scores range from 0 (no burden) to 88 (highest possible burden).
Change = (month 9 - baseline score).
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baseline and month 9
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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 From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 6
時間枠：baseline and 6 month
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PHQ-15 is a validated, self-reported instrument assessing somatization over the last 4-weeks time period.
Possible scores range from 0 (no somatization) to 30 (most possible somatization).
Change = (Month 6 Score - Baseline score)
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baseline and 6 month
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Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 9
時間枠：baseline and month 9
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PHQ-15 is a validated, self-reported instrument assessing somatization over the last 4-weeks time period.
Possible scores range from 0 (no somatization) to 30 (most possible somatization).
Change = (Month 9 Score - Baseline score)
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baseline and month 9
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Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 6
時間枠：baseline and month 6
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PHQ-4 is a validated, self-reported Instrument assessing mental health over a 2 - week period.
Possible scores range from 0 (not ill) to 18 (worst possible mental illness).
Change = (Month 6 Score - Baseline score)
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baseline and month 6
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Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 9
時間枠：baseline and month 9
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PHQ-4 is a validated, self-reported Instrument assessing mental health over a 2 - week period.
Possible scores range from 0 (not mental ill) to 18 (worst possible mental illness).
Change = (Month 9 Score - Baseline score)
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baseline and month 9
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Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 6
時間枠：baseline and month 6
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ESSI is a validated, self-reported instrument assessing perceived social support of the caregivers over a undefined period of time.
Possible scores range from 1 (no social support) to 25 (most possible social support).
Change = (month 6 score - Baseline score)
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baseline and month 6
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Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 9
時間枠：baseline and month 9
|
ESSI is a validated, self-reported instrument assessing perceived social support of the caregivers over a undefined period of time.
Possible scores range from 1 (no social support) to 25 (most possible social support).
Change = (month 9 score - Baseline score)
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baseline and month 9
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Change From Baseline in Psychological Quality of Life on the German Version of the Mental Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 6
時間枠：baseline and month 6
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SF-12 - mental component is a validated, self-reported instrument assessing psychological quality of live of the caregivers over the last four weeks time period.
Possible scores range from 0 (lowest level of health) and 100 (highest level of health).
Change = (Month 6 Score - Baseline score)
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baseline and month 6
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Change From Baseline in Psychological Quality of Life on the German Version of the Mental Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 9
時間枠：baseline and month 9
|
SF-12 is a validated, self-reported instrument assessing psychological and physical quality of live of the caregivers over the last four weeks time period.
Possible scores range from 0 (lowest level of health) and 100 (highest level of health).
Change = (Month 9 Score - Baseline score)
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baseline and month 9
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Change From Baseline in Physical Quality of Life on the German Version of the Physical Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 6
時間枠：baseline and month 6
|
SF-12 is a validated, self-reported instrument assessing psychological and physical quality of live of the caregivers over the last four weeks time period.
Possible scores range from 0 (lowest level of health) and 100 (highest level of health).
Change = (Month 6 Score - Baseline score)
|
baseline and month 6
|
|
Change From Baseline in Physical Quality of Life on the German Version of the Physical Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 9
時間枠：baseline and month 9
|
SF-12 is a validated, self-reported instrument assessing psychological and physical quality of live of the caregivers over the last four weeks time period.
Possible scores range from 0 (lowest level of health) and 100 (highest level of health).
Change = (Month 9 Score - Baseline score)
|
baseline and month 9
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Change From Baseline in Frequency of Problem Behavior on a German Version of the Frequency Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 6
時間枠：baseline and month 6
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RMBPC frequency subscale is a validated, proxy-reported instrument assessing the frequency of problem behavior of cognitively impaired persons over the last week time period.
Possible scores range from 0 (never occured) and 96 (extremely often).
Change = (Month 6 Score - Baseline score)
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baseline and month 6
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Change From Baseline in Frequency of Problem Behavior on a German Version of the Frequency Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 9
時間枠：baseline and month 9
|
The frequency subscale of the RMBPC is a validated proxy-reported instrument assessing the frequency of problem behavior of cognitively impaired persons over the last week time period.
Possible scores range from 0 (never occured) and 96 (extremely often).
Change = (Month 9 Score - Baseline score)
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baseline and month 9
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Change From Baseline in Strength of Reaction of Caregivers to Problem Behavior on a German Version of the Reaction Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 6
時間枠：baseline and month 6
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RMBPC reaction subscale is a validated self-reported instrument assessing the strength of reaction of caregivers to problem behavior of cognitively impaired persons over the last week time period.
Possible scores range from 0 (no reaction) and 96 (extremely strong reaction).
Change = (Month 6 Score - Baseline score)
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baseline and month 6
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Change From Baseline in Strength of Reaction of Caregivers to Problem Behavior on a German Version of the Reaction Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 9
時間枠：baseline and month 9
|
RMBPC reaction subscale is a validated self-reported instrument assessing the strength of reaction of caregivers to problem behavior of cognitively impaired persons over the last week time period.
Possible scores range from 0 (no reaction) and 96 (extremely strong reaction).
Change = (Month 9 Score - Baseline score)
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baseline and month 9
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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
捜査官
- 主任研究者：Hermann-Josef Gertz, Prof. Dr.、Klinik und Poliklinik für Psychiatrie der Universität Leipzig
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。
一般刊行物
- Belle SH, Burgio L, Burns R, Coon D, Czaja SJ, Gallagher-Thompson D, Gitlin LN, Klinger J, Koepke KM, Lee CC, Martindale-Adams J, Nichols L, Schulz R, Stahl S, Stevens A, Winter L, Zhang S; Resources for Enhancing Alzheimer's Caregiver Health (REACH) II Investigators. Enhancing the quality of life of dementia caregivers from different ethnic or racial groups: a randomized, controlled trial. Ann Intern Med. 2006 Nov 21;145(10):727-38. doi: 10.7326/0003-4819-145-10-200611210-00005.
- Berwig M, Heinrich S, Spahlholz J, Hallensleben N, Brahler E, Gertz HJ. Individualized support for informal caregivers of people with dementia - effectiveness of the German adaptation of REACH II. BMC Geriatr. 2017 Dec 12;17(1):286. doi: 10.1186/s12877-017-0678-y.
- Heinrich S, Berwig M, Simon A, Janichen J, Hallensleben N, Nickel W, Hinz A, Brahler E, Gertz HJ. German adaptation of the Resources for Enhancing Alzheimer's Caregiver Health II: study protocol of a single-centred, randomised controlled trial. BMC Geriatr. 2014 Feb 12;14:21. doi: 10.1186/1471-2318-14-21.
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
2012年10月1日
一次修了 (実際)
2015年1月1日
研究の完了 (実際)
2015年1月1日
試験登録日
最初に提出
2012年9月17日
QC基準を満たした最初の提出物
2012年9月20日
最初の投稿 (見積もり)
2012年9月21日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年11月29日
QC基準を満たした最後の更新が送信されました
2016年10月5日
最終確認日
2016年10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。
GE-REACH-programの臨床試験
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Tufts Medical CenterNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)積極的、募集していない
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University of Southern CaliforniaUniversity of California, Los Angeles; University of California, Irvine募集
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City University of Hong KongStanford University; Harvard University完了
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Memphis VA Medical CenterU.S. Army Medical Research and Development Command完了
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Texas Scottish Rite Hospital for Childrenまだ募集していません