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Video Decision Aid for Chronic Kidney Failure (VIDEO-KD Trial)
N/A
Recruiting
Led By Michael Paasche-Orlow, MD, MPH
Research Sponsored by Boston Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients age ≥70 with a diagnosis of CKD and less than a two-year prognosis from any cause, defined by the clinician answering 'NO' to the Surprise Question ('Would you be surprised if this patient died in the next two years?')
Patients age ≥70 with Advanced CKD defined as ONE eGFR value ≤ 30 ml/min/1.73m2 in the past 12 months NOT determined to be a result of AKI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 months
Awards & highlights
VIDEO-KD Trial Summary
This trial will test whether an ACP video intervention can reduce the burden of CKD for older patients.
Who is the study for?
This trial is for older adults with advanced chronic kidney disease (CKD). Eligible participants are those aged 70+ with an eGFR ≤30 ml/min/1.73m2 or a prognosis of less than two years, and those aged 65-69 meeting both criteria. Excluded are new patients, those listed for transplant, on dialysis, visually impaired beyond correction, or cognitively impaired.Check my eligibility
What is being tested?
The study tests whether an advance care planning video can help manage CKD in aging individuals compared to usual care. It's a multi-center randomized trial where some will watch the decision aid video and others will continue with their regular treatment without the video.See study design
What are the potential side effects?
Since this intervention involves educational material rather than medication, traditional side effects aren't expected. However, emotional or psychological discomfort may arise from discussing end-of-life decisions.
VIDEO-KD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 70 or older with CKD and my doctor thinks I may not live more than two years.
Select...
I am 70 or older with advanced kidney disease not due to a sudden injury.
VIDEO-KD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Advance Care Planning (ACP) in Electronic Health Record (EHR) Documentation
Secondary outcome measures
Acceptability of video intervention
Change in ACP Conversations
Change in ACP Engagement
+6 moreVIDEO-KD Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Video Decision AidExperimental Treatment1 Intervention
The video intervention consists of a video decision aid along with a video declaration (ViDec), which is recorded by the patient. The video decision aid explores ACP options for medical care for end-stage renal disease (ESRD) and reviews hemodialysis, peritoneal dialysis, as well as medical management without dialysis; it also reviews cardiopulmonary resuscitation (CPR). Patients will also audio- or video-record their preferences using a tablet.
Group II: Usual CareActive Control1 Intervention
Usual clinical care
Find a Location
Who is running the clinical trial?
Boston Medical CenterLead Sponsor
383 Previous Clinical Trials
870,550 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,325 Total Patients Enrolled
Tufts Medical CenterLead Sponsor
255 Previous Clinical Trials
254,687 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My vision is worse than 20/200 even with glasses or contacts.I am 70 or older with CKD and my doctor thinks I may not live more than two years.I am on the kidney transplant list or have received a kidney transplant.I am 70 or older with advanced kidney disease not due to a sudden injury.I am currently on or have been on dialysis.I am 65-69, have advanced CKD not due to AKI, and my doctor thinks I may not live more than 2 years.I have difficulty with memory or thinking clearly.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care
- Group 2: Video Decision Aid
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can you provide an estimate of the number of research facilities running this project in North America?
"8 medical centres are participating in the trial, including Boston Medical Center, Brigham & Women's Hospital and Massachusetts General Hospital. Additional sites can be found across America as well."
Answered by AI
Is there currently an opportunity for enrolment in this experiment?
"Data on clinicaltrials.gov affirms that this medical experiment is presently seeking suitable applicants. The trial was initially listed on June 21st 2021 and has been recently modified as of October 18th 2022."
Answered by AI
What is the current recruitment rate for this clinical investigation?
"In order to adequately conclude this research, 600 suitable participants must be recruited. These patients can join the study from sites such as Boston Medical Center in Massachusetts and Brigham & Women's Hospital in Seattle, Washington."
Answered by AI
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