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Shared Decision Making for Chronic Kidney Disease (DIAL-SDM Trial)
N/A
Waitlist Available
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 12 months
Awards & highlights
DIAL-SDM Trial Summary
This trial is testing a dialysis shared decision-making (DIAL-SDM) intervention for nephrologists and their patients ≥65 years old with an estimated glomerular filtration rate (eGFR) of ≤ 20 ml/min/ /1.73 m2. The intervention includes communication training and coaching sessions for patients (and caregivers, if available) to explore each patient's relevant contextual information (values, preferences, and goals), and help them identify and practice important questions for their nephrologist. The study outcomes will be assessed during two nephrology office visits and at 6 months.
Who is the study for?
This trial is for patients aged 65 or older with advanced chronic kidney disease (stages 4 or 5) who haven't yet decided on dialysis and speak English. Their nephrologist must be part of the study and working at Strong Memorial Hospital. Caregivers involved in patient care can also participate.Check my eligibility
What is being tested?
The trial tests a shared decision-making program (DIAL-SDM) against usual care for kidney disease treatment choices. Nephrologists will get communication training, while patients receive coaching to help them discuss their treatment preferences effectively.See study design
What are the potential side effects?
Since this intervention involves education and communication rather than medication, there are no direct medical side effects; however, participants may experience emotional or psychological impacts from discussing sensitive health decisions.
DIAL-SDM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
acceptability of DIAL-SDM intervention
feasibility of DIAL-SDM intervention
Interventional procedure
DIAL-SDM Trial Design
2Treatment groups
Experimental Treatment
Group I: interventionExperimental Treatment1 Intervention
Group II: controlExperimental Treatment1 Intervention
Usual care
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Who is running the clinical trial?
University of RochesterLead Sponsor
845 Previous Clinical Trials
534,957 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,720 Previous Clinical Trials
7,494,167 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,376 Previous Clinical Trials
4,315,707 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are 65 years or older, have severe kidney disease, have seen a kidney doctor, speak English, have not attended a class about dialysis, and have not decided about starting dialysis.You have already met with a palliative care doctor or are in hospice care, are currently receiving dialysis, are in the hospital, have trouble thinking clearly, or do not speak English.I am a caregiver, 21 or older, helping someone with their health care.I am a caregiver by profession and have cognitive impairment.
Research Study Groups:
This trial has the following groups:- Group 1: intervention
- Group 2: control
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.
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