NCT02698722

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 4, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

July 19, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2019

Completed
Last Updated

October 7, 2019

Status Verified

October 1, 2019

Enrollment Period

2.7 years

First QC Date

February 22, 2016

Last Update Submit

October 3, 2019

Conditions

Chronic Kidney DiseaseDecision-making

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

Control

NO INTERVENTION

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

Intervention

EXPERIMENTAL

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

Interventions

End-stage renal disease treatment optionsOTHER

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

Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Known history of dementia
  • Legally blind
  • Listed for kidney transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

    PMID: 32791499DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Internist

Study Record Dates

First Submitted

February 22, 2016

First Posted

March 4, 2016

Study Start

July 19, 2016

Primary Completion

March 22, 2019

Study Completion

March 22, 2019

Last Updated

October 7, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)