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

This study is currently recruiting participants.
Verified July 2017 by James Rodrigue, Beth Israel Deaconess Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01786525
First Posted: February 8, 2013
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
James Rodrigue, Beth Israel Deaconess Medical Center
  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 (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:


Further study details as provided by James Rodrigue, 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 ]

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 ]

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 ]

Estimated Enrollment: 150
Study Start Date: June 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: November 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01786525


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

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center 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

Responsible Party: James Rodrigue, Associate Professor, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01786525     History of Changes
Other Study ID Numbers: 2012P000332
R01DK098727 ( U.S. NIH Grant/Contract )
First Submitted: February 6, 2013
First Posted: February 8, 2013
Last Update Posted: July 13, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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