Back to resultsA Video Decision Support Tool to Assist Elderly Patients in ESRD Treatment Decision-making
Primary Purpose
Chronic Kidney Disease, Decision-making
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
End-stage renal disease treatment options
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Kidney Disease
Eligibility Criteria
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
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
This group will receive verbal education about dialytic and non-dialytic therapies via a standardized script.
This group will receive the intervention which is a 11.5 minute video about dialysis and non-dialytic therapies.
Outcomes
Primary Outcome Measures
Change in knowledge of end-stage renal disease treatments (hemodialysis vs. peritoneal dialysis vs. supportive care) via survey
Secondary Outcome Measures
Change in preference for end-stage renal disease treatment (hemodialysis vs. peritoneal dialysis vs. supportive care) via survey
Full Information
NCT ID
NCT02698722
First Posted
February 22, 2016
Last Updated
October 3, 2019
Sponsor
Massachusetts General Hospital
Collaborators
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT02698722
Brief Title
A Video Decision Support Tool to Assist Elderly Patients in ESRD Treatment Decision-making
Official Title
A Video Decision Support Tool to Assist Elderly Patients in ESRD Treatment Decision-making - A Pilot Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
July 19, 2016 (Actual)
Primary Completion Date
March 22, 2019 (Actual)
Study Completion Date
March 22, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
University of Pennsylvania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Decision-making
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
This group will receive verbal education about dialytic and non-dialytic therapies via a standardized script.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
This group will receive the intervention which is a 11.5 minute video about dialysis and non-dialytic therapies.
Intervention Type
Other
Intervention Name(s)
End-stage renal disease treatment options
Intervention Description
This group will receive the intervention which is a 11.5 minute video about dialysis and non-dialytic therapies.
Primary Outcome Measure Information:
Title
Change in knowledge of end-stage renal disease treatments (hemodialysis vs. peritoneal dialysis vs. supportive care) via survey
Time Frame
Change in knowledge immediately pre and post intervention and at 12 weeks
Secondary Outcome Measure Information:
Title
Change in preference for end-stage renal disease treatment (hemodialysis vs. peritoneal dialysis vs. supportive care) via survey
Time Frame
Change in preferences Immediately pre and post intervention and at 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32791499
Citation
Eneanya ND, Percy SG, Stallings TL, Wang W, Steele DJR, Germain MJ, Schell JO, Paasche-Orlow MK, Volandes AE. Use of a Supportive Kidney Care Video Decision Aid in Older Patients: A Randomized Controlled Trial. Am J Nephrol. 2020;51(9):736-744. doi: 10.1159/000509711. Epub 2020 Aug 13.
Results Reference
derived
Learn more about this trial
A Video Decision Support Tool to Assist Elderly Patients in ESRD Treatment Decision-making
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