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Behavioural Intervention
Education Programs for Chronic Kidney Disease (ExPAND Trial)
N/A
Waitlist Available
Research Sponsored by George Washington University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Person with CKD, cared for at participating clinic:
Age 65 years or older
Must not have
The patient is a candidate for kidney transplant
Insufficient decision making capacity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up starts after consent to participate in longitudinal interviews. repeats every 4 months until first of project completion or patient death, assessed up to 40 months.
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to compare two different approaches in how kidney failure treatment options are presented to older patients. The first approach focuses on educating patients about all available treatment choices, including alternative options, and engaging them
Who is the study for?
This trial is for older patients with kidney failure who are exploring treatment options. Participants should be willing to engage in educational programs about kidney disease, use decision aids, and participate in shared decision-making processes.
What is being tested?
The study compares two approaches: 'Educate and Engage' which involves education and shared decision-making support, versus 'Educate and Engage Plus Kidney Supportive Care Program' that adds palliative care support for those choosing alternative treatments.
What are the potential side effects?
Since this trial focuses on educational interventions and supportive care rather than medications or invasive procedures, traditional side effects are not a concern. However, emotional or psychological impacts may arise from discussing end-of-life choices.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have chronic kidney disease and am treated at a participating clinic.
Select...
I am 65 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am eligible for a kidney transplant.
Select...
I am unable to make my own medical decisions.
Select...
I do not speak English or Spanish.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ starts after consent to participate in longitudinal interviews. repeats every 4 months until first of project completion or patient death, assessed up to 40 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~starts after consent to participate in longitudinal interviews. repeats every 4 months until first of project completion or patient death, assessed up to 40 months.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Decisional Conflict Scale score
Proportion of patients choosing Alternative Treatment Plans (ATP)
Secondary study objectives
AMCWD & DND patients who initiate dialysis in the last month of life
Advance care planning (ACP) documentation
CollaboRATE score
+11 moreOther study objectives
ATP patient reports of experience of ATP care (qualitative)
Acceptability (Organizational)
Appropriateness (Organizational)
+12 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Educate and Engage Plus Kidney Supportive Care ProgramExperimental Treatment1 Intervention
Patients accrued and making treatment decisions while the clinic treating them is implementing Approach 2.
Group II: Educate and EngageExperimental Treatment1 Intervention
Patients accrued and making treatment decisions while the clinic treating them is implementing Approach 1.
Find a Location
Who is running the clinical trial?
George Washington UniversityLead Sponsor
252 Previous Clinical Trials
458,150 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
574 Previous Clinical Trials
27,076,132 Total Patients Enrolled
West Virginia University Research CorporationUNKNOWN
1 Previous Clinical Trials
476 Total Patients Enrolled
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