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Completed

NCT Number: NCT02698722

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

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Decision-Making Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

End-stage renal disease treatment options

Other

This group will receive the intervention which is a 11.5 minute video about dialysis and non-dialytic therapies.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • University of Pennsylvania

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 4, 2016
Registry last updated
Oct 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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