A Video Decision Support Tool to Assist Elderly Patients in ESRD Treatment Decision-making

Chronic Kidney Disease Clinical Trial

Official title:

A Video Decision Support Tool to Assist Elderly Patients in ESRD Treatment Decision-making - A Pilot Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02698722
• Other study ID #: 2014P002432
• Status: Completed
• Phase: N/A
• Start date: July 19, 2016
• Est. completion date: March 22, 2019

Study information

• Verified date: October 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the United States, it is estimated that there are approximately 630,000 patients who have ESRD with two-thirds of those patients subsequently receiving maintenance dialysis. Studies have demonstrated that the initiation and timing of dialysis for those with ESRD seem to vary widely regionally - confirming the uncertainty of the benefits of chronic dialysis in this population

Pre-dialysis education programs inform patients of all of their options allowing them to choose renal replacement therapy that is most consistent with their wishes. Recent evidence has supported using different methods of delivering education including videos to complement standard clinical care practices to promote informed decision making. This proposed study will serve to examine the efficacy of a dialysis modality video decision support tool to inform chronic kidney disease patients of different dialytic and non-dialytic therapies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 22, 2019
• Est. primary completion date: March 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• English-speaking during clinical encounters

• Stage 4 or 5 CKD (defined by the Chronic Kidney Disease Epidemiology Collaboration for estimation of GFR < 30 ml/min/1.73m2)

Exclusion Criteria:

• Known history of dementia

• Legally blind

• Listed for kidney transplant

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Decision-making
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• End-stage renal disease treatment options
This group will receive the intervention which is a 11.5 minute video about dialysis and non-dialytic therapies.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in knowledge of end-stage renal disease treatments (hemodialysis vs. peritoneal dialysis vs. supportive care) via survey		Change in knowledge immediately pre and post intervention and at 12 weeks
Secondary	Change in preference for end-stage renal disease treatment (hemodialysis vs. peritoneal dialysis vs. supportive care) via survey		Change in preferences Immediately pre and post intervention and at 12 weeks