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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02488317
Other study ID # 1109201303123
Secondary ID
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


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
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