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

NCT ID: NCT02698722

Last Updated: 2019-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-19

Study Completion Date

2019-03-22

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Kidney Disease Decision-making

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control

This group will receive verbal education about dialytic and non-dialytic therapies via a standardized script.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

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

Group Type EXPERIMENTAL

End-stage renal disease treatment options

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Angelo E. Volandes, MD

Internist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32791499 (View on PubMed)

Other Identifiers

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2014P002432

Identifier Type: -

Identifier Source: org_study_id

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