NCT01048437

Brief Summary

This study is a group-randomized controlled trial to explore whether improved community transplant education for renal patients not yet on dialysis could increase patients' willingness to pursue preemptive living donor transplant (PLDT) and PLDT rates.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
370

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Typical duration for not_applicable

Geographic Reach
1 country

5 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

Study Start

First participant enrolled

September 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2009

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 13, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

September 15, 2011

Status Verified

September 1, 2011

Enrollment Period

2.9 years

First QC Date

July 20, 2009

Last Update Submit

September 13, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • Willingness to pursue preemptive living donor transplant

    pre and post-class

Secondary Outcomes (1)

  • Preemptive living donor transplant rates

    1-2 years

Study Arms (3)

Standard transplant education

NO INTERVENTION

Missouri Kidney Program's standard Patient Education Program (PEP) transplant module.

Transplant education with video

EXPERIMENTAL

Explore Transplant transplant module featuring video

Behavioral: Transplant education with video

Transplant education with speakers

EXPERIMENTAL

Explore Transplant transplant module featuring live guest speakers.

Behavioral: Transplant education with speakers

Interventions

1 hour standard transplant module is replaced with the Explore Transplant presentation and 20 minute video featuring transplant patients and donors

Transplant education with video

1 hour standard transplant module is replaced with the Explore Transplant presentation and 3 live speakers: 1 deceased donor recipient, 1 living donor recipient and 1 living donor

Transplant education with speakers

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic kidney disease
  • Attend all 6 education modules
  • + years of age
  • Have given consent by signing informed consent
  • Speak and understand English
  • Can read and understand questionnaires

You may not qualify if:

  • Patients who do not speak and understand English (material is presented orally)
  • Patients who cannot read and understand the questionnaires
  • Patients who are 17 years of age or younger

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Missouri Kidney Program

Overland Park, Kansas, 66212, United States

Location

Missouri Kidney Program

Springfield, Missouri, 65807, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Missouri Kidney Program

St Louis, Missouri, 63122, United States

Location

Missouri Kidney Program

Warrensburg, Missouri, 64093, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicKidney Failure, Chronic

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Officials

  • Amy D Waterman, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

July 20, 2009

First Posted

January 13, 2010

Study Start

September 1, 2008

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

September 15, 2011

Record last verified: 2011-09

Locations