Empowering Patients On Choices for Renal Replacement Therapy (Aim 3) (EPOCH-RRT)

Chronic Kidney Disease Clinical Trial

— EPOCH-RRT  

Official title:

Empowering Patients On Choices for Renal Replacement Therapy (Aim 3)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02488317
• Other study ID #: 1109201303123
• Status: Completed
• Phase: N/A
• First received: June 15, 2015
• Last updated: January 13, 2016
• Start date: May 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Arbor Research Collaborative for Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Empowering Patients On Choices for Renal Replacement Therapy (EPOCH-RRT) study seeks to identify factors that matter the most to patients with kidney disease and study how they are impacted by different types of dialysis. The inclusion of patients, caregivers, and patient advocacy organizations as research partners will assure that the study addresses questions of greatest relevance to patients facing the need for dialysis.

For Aim 3, the investigators are going to compare measures related to the decision-making process between patients receiving and not receiving a decision aid focusing on Peritoneal Dialysis and Hemodialysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years and older

• Speaks English

• Has access to the internet

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Decision Aid
Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.

Locations

Country	Name	City	State
United States	Arbor Research Collaborative for Health	Ann Arbor	Michigan

Sponsors (6)

Lead Sponsor	Collaborator
Arbor Research Collaborative for Health	American Association of Kidney Patients, Henry Ford Health System, National Kidney Foundation, Patient-Centered Outcomes Research Institute, University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preference for shared decision making	Measured using the scale from Degner, L. F., Sloan, J. A., & Venkatesh, P. (1996). The Control Preferences Scale. The Canadian journal of nursing research= Revue canadienne de recherche en sciences infirmieres, 29(3), 21-43	6 months	No
Primary	Decisional conflict	Measured using the scale from O'Connor, Annette M. "Validation of a Decisional Conflict Scale." Medical Decision Making 15, no. 1 (February 1, 1995): 25-30	6 months	No
Primary	Decision self-efficacy	Measured through the scale found in Decision Self-Efficacy Ottawa: Ottawa Hospital Research Institute; © 1995 Available from: http://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decision_SelfEfficacy.pdf O'Connor 1995	6 months	No
Primary	Knowledge	Measured using scale from Cavanaugh K"Patient Dialysis Knowledge Is Associated with Permanent Arteriovenous Access Use in Chronic Hemodialysis." Clinical Journal of the American Society of Nephrology 4, no. 5: 950-56)	6 months	No
Primary	Preparation for decision making	Measured using Bennett, Carol, "Validation of a Preparation for Decision Making Scale." Patient Education and Counseling 78, no. 1: 130-33	6 months	No