NCT00938795

Brief Summary

The goal of this study is to improve symptoms and quality of life for end-stage liver disease patients awaiting a liver transplant and their caregivers by providing them with the resources and tools to self-manage their complex concerns.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 14, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

February 7, 2014

Status Verified

February 1, 2014

Enrollment Period

3.6 years

First QC Date

July 10, 2009

Last Update Submit

February 6, 2014

Conditions

Liver Diseases

Keywords

liver diseaseuncertaintyself management

Outcome Measures

Primary Outcomes (1)

  • Uncertainty Management

    Five months

Secondary Outcomes (3)

  • Symptom control

    Five months

  • Quality of life

    Five months

  • Psychological distress

    Five months

Study Arms (2)

Uncertainty Management Intervention

OTHER

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.

Other: Uncertainty Management Intervention

Comparison Conditions for Liver Disease

OTHER

Six 30-minute telephone calls that provide structured education about liver disease.

Other: Comparison Conditions for Liver Transplant

Interventions

Uncertainty Management InterventionOTHER

Six 30-minute telephone calls with a nurse to discuss emotional and physical aspects of liver disease and awaiting liver transplant

Uncertainty Management Intervention
Comparison Conditions for Liver TransplantOTHER

Six 30-minute telephone calls that provide structured education about liver disease.

Comparison Conditions for Liver Disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of ESLD and on the liver transplant waiting list
  • Receiving care at a Liver Clinic in the United States
  • 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
  • years of age or older
  • Able to read and speak English
  • Provides care to a patient meeting the above criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

The University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

University of North Carolina-Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

The University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

MeSH Terms

Conditions

Liver Diseases

Interventions

Liver Transplantation

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsDigestive System Surgical ProceduresSurgical Procedures, OperativeOrgan TransplantationTransplantation

Study Officials

  • James Tulsky, MD

    Duke University School of Nursing

    PRINCIPAL INVESTIGATOR

  • Donald Bailey, PhD

    Duke University School of Nursing

    PRINCIPAL INVESTIGATOR

  • Annette Devito Dabbs, PhD, RN

    The University of Pittsburgh

    PRINCIPAL INVESTIGATOR

  • Paul H. Hayashi, MD, MPH

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

  • Laurel Williams-Salonen, RN,MSN,CCTC

    The University of Nebraska Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2009

First Posted

July 14, 2009

Study Start

February 1, 2010

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

February 7, 2014

Record last verified: 2014-02

Locations

US(4)