Uncertainty Management Intervention
Uncertainty Management Intervention for Patients Awaiting Liver Transplant
調査の概要
状態
条件
詳細な説明
Hepatitis C Virus is the most common blood-borne infection in the U.S., affecting at least 4 million individuals, with more than 19,000 new cases occurring each year. Further, the CDC has projected a fourfold increase in the number of chronic hepatitis C patients between 1990 and 2015, and these patients are at risk for developing end stage liver disease (ESLD). By 2015 an estimated 375,000 chronic hepatitis C patients will develop cirrhosis and progress to ESLD, representing the majority of individuals who need liver transplants. ESLD is a life-limiting illness, and patients are told that, without a liver transplant, they may die.
This 5 year randomized controlled trial will test the efficacy of an Uncertainty Management Intervention delivered via telephone by a nurse to the patient and caregiver. An attention control group of patients and caregivers will receive phone calls to discuss their experience of awaiting a liver transplant. Based on the problems and concerns of patients waiting for a liver transplant and the prior success of the Intervention for patients dealing with serious chronic illness, we believe the Uncertainty Management Intervention adapted specifically for ESLD patients will lead to significant improvements in patients' and caregivers' abilities to manage the symptoms and distress associated with ESLD and the process of awaiting liver transplant.
The specific aims are to: 1) examine the effects of the Uncertainty Management Intervention on patient outcomes of psychological distress, uncertainty management, symptom control, self efficacy for symptom management, and QOL compared to an attention control group receiving calls to discuss their disease experience; 2) explore the effects of the Intervention on caregiver outcomes of uncertainty management, self-efficacy for helping the patient manage symptoms, and better QOL compared to an attention control group; 3) identify characteristics of individuals for whom the intervention is particularly effective.
Waiting for a liver transplant under conditions of uncertainty is a harrowing experience for patients and caregivers, yet there have been few attempts to test nursing interventions for ESLD patients. The overall goal of this project is to provide these patients and their caregivers the tools to self-manage their complex concerns. The anticipated outcome is ESLD patients awaiting liver transplant benefit from the Uncertainty Management Intervention, thus providing new knowledge for practitioners and policy makers.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Nebraska
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Omaha、Nebraska、アメリカ、68198
- The University of Nebraska Medical Center
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North Carolina
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Chapel Hill、North Carolina、アメリカ、27599
- University of North Carolina-Chapel Hill
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Durham、North Carolina、アメリカ、27705
- Duke University
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15261
- The University of Pittsburgh
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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 (patient):
- Diagnosis of ESLD and on the liver transplant waiting list
- Receiving care at a Liver Clinic in the United States
- 18 years of age or older
- MELD greater than or equal to 11
- Able to read and speak English
- No major cognitive impairment
- Not a recipient of a prior transplant (any organ)
- Has a caregiver willing to participate
Inclusion Criteria (caregiver):
- 18 years of age or older
- Able to read and speak English
- Provides care to a patient meeting the above criteria
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: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: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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他の:Uncertainty Management Intervention
The Uncertainty Management Intervention will consist of six 30-minute phone calls with a study educator to discuss issues of psychological distress, uncertainty management, symptom control, self efficacy for symptom management, and quality of life.
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Six 30-minute telephone calls with a nurse to discuss emotional and physical aspects of liver disease and awaiting liver transplant
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他の:Comparison Conditions for Liver Disease
Six 30-minute telephone calls that provide structured education about liver disease.
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Six 30-minute telephone calls that provide structured education about liver disease.
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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 |
時間枠 |
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Uncertainty Management
時間枠:Five months
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Five months
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二次結果の測定
結果測定 |
時間枠 |
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Symptom control
時間枠:Five months
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Five months
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Quality of life
時間枠:Five months
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Five months
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Psychological distress
時間枠:Five months
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Five months
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協力者と研究者
スポンサー
捜査官
- 主任研究者:James Tulsky, MD、Duke University School of Nursing
- 主任研究者:Donald Bailey, PhD、Duke University School of Nursing
- 主任研究者:Annette Devito Dabbs, PhD, RN、The University of Pittsburgh
- 主任研究者:Paul H. Hayashi, MD, MPH、University of North Carolina, Chapel Hill
- 主任研究者:Laurel Williams-Salonen, RN,MSN,CCTC、The University of Nebraska Medical Center
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
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。
Uncertainty Management Interventionの臨床試験
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University of MichiganNational Institute on Drug Abuse (NIDA)募集
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University of PittsburghCenters for Disease Control and Preventionまだ募集していません暴力, ドメスティック | 思春期の暴力 | 暴力、性的 | 暴力、身体的 | 暴力, 偶然ではない | 社会的結束 | 暴力、構造 | コミュニティ内暴力アメリカ
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Medstar Health Research InstituteAmenity Health, Inc.終了しました
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University of California, San FranciscoSan Francisco Veterans Affairs Medical Center; Tobacco Related Disease Research Program完了
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University of Southern CaliforniaNational Institutes of Health (NIH)積極的、募集していない
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Massachusetts General HospitalNational Institutes of Health (NIH); Samaritans of Bostonまだ募集していません自殺念慮 | 自殺未遂 | 自殺
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George Washington UniversityTranscultural Psychosocial Organization Nepal完了