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A Video Decision Support Tool to Assist Patients in Dialysis Decision-making Versus Conservative Kidney Management

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ClinicalTrials.gov Identifier: NCT02698722
Recruitment Status : Recruiting
First Posted : March 4, 2016
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Nwamaka D. Eneanya, M.D., Massachusetts General Hospital

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 effectiveness of a dialysis modality video decision support tool to inform chronic kidney disease patients of different dialytic and non-dialytic therapies.


Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Decision-making Other: End-stage renal disease treatment options Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official Title: A Video Decision Support Tool to Assist Patients in Dialysis Decision-making Versus Conservative Kidney Management - A Pilot Randomized Control Trial
Study Start Date : February 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
This group will receive verbal education about dialytic and non-dialytic therapies via a standardized script.
Experimental: Intervention
This group will receive the intervention which is a 11.5 minute video about dialysis and non-dialytic therapies.
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.




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698722


Contacts
Contact: Nwamaka D Eneanya, MD, MPH 617-643-4540

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Nwamaka Eneanya, MD, MPH    617-643-4540      
Sponsors and Collaborators
Massachusetts General Hospital

Responsible Party: Nwamaka D. Eneanya, M.D., Nephrologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02698722     History of Changes
Other Study ID Numbers: 2014P002432
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency