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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02698722
Other study ID # 2014P002432
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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