- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00938795
Uncertainty Management Intervention
Uncertainty Management Intervention for Patients Awaiting Liver Transplant
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Nebraska
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Omaha, Nebraska, 미국, 68198
- The University of Nebraska Medical Center
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599
- University of North Carolina-Chapel Hill
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Durham, North Carolina, 미국, 27705
- Duke University
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15261
- The University of Pittsburgh
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: 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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다른: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Uncertainty Management
기간: Five months
|
Five months
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Symptom control
기간: Five months
|
Five months
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Quality of life
기간: Five months
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Five months
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Psychological distress
기간: Five months
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Five months
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: James Tulsky, MD, Duke University School of Nursing
- 수석 연구원: Donald Bailey, PhD, Duke University School of Nursing
- 수석 연구원: Annette Devito Dabbs, PhD, RN, The University of Pittsburgh
- 수석 연구원: Paul H. Hayashi, MD, MPH, University of North Carolina, Chapel Hill
- 수석 연구원: Laurel Williams-Salonen, RN,MSN,CCTC, The University of Nebraska Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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