Proactive Palliative Care for Patients With Ventricular Assist Devices (VAD) and Their Families
2013年9月5日 更新者:Icahn School of Medicine at Mount Sinai
Randomized Controlled Trial of Proactive Palliative Care for Patients With Ventricular Assist Devices and Their Families
The primary aim of the study is to provide "proof of concept" to demonstrate that patients with Ventricular Assist Devices (VADs) and caregivers are willing to be enrolled in a randomized trial of palliative care and that such a study is feasible.
Secondary aims include demonstrating improvement in symptoms (physical and psychological) for intervention patients and their caregivers as compared to control patients and caregivers.
The investigators will also examine differences in utilization of healthcare services, mortality, and completion of advance directives between intervention and control patients.
調査の概要
詳細な説明
A ventricular assist device is an implanted mechanical device which augments the pumping function of the heart's ventricles.
The number of patients with VADs is expected to increase in an exponential manner in the years to come as device technology improves and continues to show a survival benefit.
The investigators propose a randomized controlled trial of a proactive palliative care intervention for patients with VADs and their caregivers.
Patients randomized to palliative care will receive ongoing counseling and symptom assessment as well as clarification and documentation of goals of care, starting before implantation and continuing throughout the course of the study.
The intervention is delivered primarily in the outpatient setting by a palliative care nurse practitioner.
Intervention patients will also be followed by the inpatient palliative care consultation service when hospitalized for their initial VAD implantation and during any subsequent hospitalizations as needed.
Control patients will receive usual care as provided by the VAD clinical team.
Data collection will be performed by a research assistant at Mount Sinai (blinded to randomization) who conducts baseline assessments in person, and then follow-up assessments over the phone.
The primary aim of the study is to provide "proof of concept" to demonstrate that patients and caregivers are willing to be enrolled in a randomized trial of palliative care and that such a study is feasible.
Secondary aims include demonstrating improvement in symptoms (physical and psychological) for intervention patients and their caregivers as compared to control patients and caregivers.
研究の種類
介入
入学 (実際)
18
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
-
-
New York
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New York、New York、アメリカ、10029
- Icahn School of Medicine at Mount Sinai
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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:
- age >21 years
- fluent in English
- have a caregiver/family member who is willing to be enrolled and who is also fluent in English
- consistent and reliable access to a phone
Exclusion Criteria:
- non English-speaking
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:支持療法
- 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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他の:コントロール
いつものお手入れ
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Receive usual care as provided by the VAD clinical team.
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アクティブコンパレータ:Palliative Care
Receive ongoing counseling and symptom assessment as well as clarification and documentation of goals of care, starting before implantation and continuing throughout the course of the study.
Intervention patients will also be followed by the inpatient palliative care consultation service when hospitalized for their initial VAD implantation and during any subsequent hospitalizations as needed
|
Receive ongoing counseling and symptom assessment as well as clarification and documentation of goals of care, starting before implantation and continuing throughout the course of the study.
Intervention patients will also be followed by the inpatient palliative care consultation service when hospitalized for their initial VAD implantation and during any subsequent hospitalizations as needed
|
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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Pain Assessment - change at 1 year from baseline
時間枠:baseline (within 2 weeks of enrollment) and at 1 year after implantment
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change in pain from baseline to 1 year, using the Memorial Symptom Assessment Scale
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baseline (within 2 weeks of enrollment) and at 1 year after implantment
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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 |
|---|---|---|
|
Satisfaction with care - change at 1 year from baseline
時間枠:at baseline (within 2 weeks of enrollment) and at 1 year after implantment
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changes in satisfaction with care from baseline to 1 year as measured with validated scales for satisfaction with care.
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at baseline (within 2 weeks of enrollment) and at 1 year after implantment
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PROMIS anxiety scale - change at 1 year from baseline
時間枠:at baseline (within 2 weeks of enrollment) and at 1 year after implantment
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changes in anxiety from baseline to 1 year as measured by the PROMIS anxiety scale
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at baseline (within 2 weeks of enrollment) and at 1 year after implantment
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PROMIS depression scale - change at 1 year from baseline
時間枠:at baseline (within 2 weeks of enrollment) and at 1 year after implantment
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changes in depression measured from baseline to 1 year as measured by the PROMIS depression scale
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at baseline (within 2 weeks of enrollment) and at 1 year after implantment
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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。
協力者
捜査官
- 主任研究者:Nathan E. Goldstein, MD、Icahn School of Medicine at Mount Sinai
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
- WRITING GROUP MEMBERS; Lloyd-Jones D, Adams RJ, Brown TM, Carnethon M, Dai S, De Simone G, Ferguson TB, Ford E, Furie K, Gillespie C, Go A, Greenlund K, Haase N, Hailpern S, Ho PM, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott MM, Meigs J, Mozaffarian D, Mussolino M, Nichol G, Roger VL, Rosamond W, Sacco R, Sorlie P, Roger VL, Thom T, Wasserthiel-Smoller S, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2010 update: a report from the American Heart Association. Circulation. 2010 Feb 23;121(7):e46-e215. doi: 10.1161/CIRCULATIONAHA.109.192667. Epub 2009 Dec 17. No abstract available. Erratum In: Circulation. 2010 Mar 30;121(12):e260. Stafford, Randall [corrected to Roger, Veronique L]. Circulation. 2011 Oct 18;124(16):e425.
- Kirklin JK, Naftel DC, Kormos RL, Stevenson LW, Pagani FD, Miller MA, Ulisney KL, Baldwin JT, Young JB. Second INTERMACS annual report: more than 1,000 primary left ventricular assist device implants. J Heart Lung Transplant. 2010 Jan;29(1):1-10. doi: 10.1016/j.healun.2009.10.009. No abstract available.
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7月1日
一次修了 (実際)
2012年7月1日
研究の完了 (実際)
2012年7月1日
試験登録日
最初に提出
2011年8月15日
QC基準を満たした最初の提出物
2011年8月31日
最初の投稿 (見積もり)
2011年9月1日
学習記録の更新
投稿された最後の更新 (見積もり)
2013年9月6日
QC基準を満たした最後の更新が送信されました
2013年9月5日
最終確認日
2013年9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。