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House Calls and Decision Support: Improving Access to Live Donor Transplantation

This study is not yet open for participant recruitment.
Verified February 2013 by Beth Israel Deaconess Medical Center
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
James Rodrigue, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01786525
First received: February 6, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  Purpose

The main purpose of this research program is to reduce the burden of end-stage organ disease on individuals, families, healthcare systems, and society by increasing the availability of donor organs for transplantation. Consistent with this aim, the project further examines strategies to increase access to and reduce disparities - racial, economic, gender - in live donor kidney transplantation (LDKT). Specifically, we expand the research and intensity of an innovative House Calls intervention developed by the principal investigator by including other minorities and socioeconomically disadvantaged patients and by adding a novel Patient-Centered Decision Support component. The main study hypothesis is that participants receiving the novel intervention (House Calls + Patient-Centered Decision Support) will have a higher proportion of LDKT's by the 2-year study endpoint.


Condition Intervention
Chronic Kidney Disease
End-Stage Renal Disease
 Behavioral: House Calls
Behavioral: Web-Based Patient-Centered Decision Support Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: House Calls and Web-based Decision Support: Improving Access to Live Donor Kidney Transplantation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • The primary outcome for this study is the proportion of enrolled patients with live donor kidney transplants [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Higher proportion of enrolled patients with live donor inquires and evaluations; higher proportion of patients will be in LDKT Readiness stages 4/5 by the 12-week assessment. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Improvement in LDKT knowledge and LKDT readiness, reduced LDKT concerns and health care mistrust, greater amount of time spent discussing LDKT and higher quality interactions, and improvement in self-efficacy discussing LDKT. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: June 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: House Calls only
60-minute educational intervention in patient's home which will be delivered by a health educator.
 Behavioral: House Calls
60-minute home based educational intervention which will be administered by a health educator
Active Comparator: House Calls + Web-Based Decision Support
Home based intervention plus web-based patient-centered decision support program that will be offered to participants following the home based intervention.
 Behavioral: House Calls
60-minute home based educational intervention which will be administered by a health educator
Behavioral: Web-Based Patient-Centered Decision Support Intervention
Patients will be provided with access to the study website which will allow them to learn and receive LDKT support in a way the best meets their personal values and preferences
No Intervention: Control
100 patients on the Organ Transplant Tracking Record who are not receiving the study intervention

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • non-White race/Hispanic ethnicity/low-income (250% below federal poverty guidelines)
  • CKD/ESRD
  • meets eligibility criteria for kidney transplant waiting list
  • 21 years old or older
  • self-reports being in LDKT Readiness Stage I, II, or III
  • Resides within 3 hours driving time from transplant center

Exclusion Criteria:

  • Awaiting combined kidney-liver transplant
  • Awaiting simultaneous pancreas-kidney transplant
  • Know or suspected cognitive impairment
  • Prior participation in House Calls intervention study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01786525

Contacts
Contact: James R Rodrigue, PhD 617-632-9700

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: James R Rodrigue, PhD            
Sub-Investigator: Didier Mandelbrot, MD            
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: James R Rodrigue, PhD Beth Israel Deaconess Medical Center
Study Chair: Didier Mandelbrot, MD Beth Israel Deaconess Medical Center
Study Chair: Martha Pavlakis, MS Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: James Rodrigue, Associate Professor, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01786525     History of Changes
Other Study ID Numbers: 2012P-000332, R01DK098727
Study First Received: February 6, 2013
Last Updated: February 6, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
Live Donor Kidney Transplantation
LDKT
African American
 Disparity
Education
Patient Support

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on May 16, 2013