An interventional study of PREPARED Decision Support in Chronic Kidney Disease, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-27.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
This study evaluates the effectiveness of patient educational materials (a book and DVD) to help patients with chronic kidney disease make early, shared, and informed decisions about kidney replacement therapy. Half of the participants will receive the educational materials and half will receive usual care from their doctors.
The investigators will study the effectiveness of patient educational materials (a book and DVD, called the PREPARED materials) to help patients with chronic kidney disease make early, shared, and informed decisions about kidney replacement therapy. Half of the participants will receive the PREPARED materials and half will receive usual care from their doctors. PREPARED materials feature patients and their families discussing the pros and cons of different treatment options for kidney failure. The investigators will randomly assign patients already under the care of a nephrologist to receive the video and book or to receive their usual nephrology care. They will measure the degree to which patients in either study arm are prepared for kidney failure treatment at follow up.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 24 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants randomized to this arm of the study will receive usual care from their physician.
Participants randomized to this arm of the study will receive the PREPARED educational book and video.
Behavioral: PREPARED Decision Support
The PREPARED DVD presents patient and health care provider testimonials that characterize the pros and cons of different kidney replacement treatment options, including in-center hemodialysis, home hemodialysis, peritoneal dialysis, kidney transplant, and conservative management (i.e., no dialysis or transplant). The PREPARED book reinforces differences between the treatments by showing (in lay language) summaries of scientific evidence on treatment outcomes associated with each kidney replacement option.
Initiation of self-care dialysis or receipt of transplant
Among the participants initiating renal replacement therapy (RRT) during follow up, the proportion who initiate self-care dialysis (peritoneal dialysis or home hemodialysis) or receive a transplant.
Time frame: 90 days after randomization
Use of permanent vascular access
Proportion of patients achieving initiation of RRT with a permanent vascular access.
Time frame: 90 days after randomization
Emergent dialysis initiation
Proportion of patients initiating dialysis urgently in the Emergency Room (versus planned initiation).
Time frame: 90 days after randomization
Transplant evaluations, waiting list placement
Proportion of patients achieving receipt of transplant evaluations, or placement on the kidney transplant waiting list prior to initiation.
Time frame: 90 days after randomization
Blood pressure control at RRT initiation
Proportion of patients achieving blood pressure control (systolic blood pressure \<130mmHg and diastolic blood pressure \<80mmHg) at each visit prior to RRT initiation or completion of study follow up.
Time frame: 90 days after randomization
Anemia management
Proportion of patients with anemia treated to recommended levels (hemoglobin 10g/dl to 12g/dl) at each visit prior to RRT initiation or completion of study follow up.
Time frame: 90 days after randomization
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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