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DART trial


Title Decision Aid for Renal Therapy: Promoting Knowledge and Autonomy in Chronic Kidney Disease Patients and Their Care-Partners
Therapeutic Area Kidney Diseases
Principal Investigator Daniel Weiner, MD MS
Min Age 70 Years
Gender Any
Contact Eamon Fleming
617-636-5895
More Information https://clinicaltrials.gov/ct2/show/NCT03522740

Overview

Good communication among patients, their families and loved ones, and their medical care providers is important when figuring out how to treat chronic diseases like kidney disease. A lot of people may not know their choices for how to treat kidney disease, and this can lead to rushed decisions or even a sense that there weren't any choices to make. In this study, we are trying to find out if a decision-aid program on a computer can help people with kidney disease have more confidence in their decisions and have better agreement about their decisions with their families and loved ones.

Study Details

Inclusion Criteria

  • Stage 4 or 5 chronic kidney disease
  • Age 70 years or older
  • English speaking

Exclusion Criteria

  • Currently on dialysis
  • Planning to start dialysis within the next three months
  • Transplant procedure schedules within the next three months 

Study Requirements

If you agree to participate in this study, you will be randomly assigned (meaning you have a 50% chance) to one or two study groups one group will receive usual care, including standard education methods, and the other group will receive usual care and standard education methods, plus DART. In both groups, you will see your doctors like you usually do. 

People in both the usual care group and the DART group will complete six or seven research visits. We will try do do these visits at the same time when you see your kidney doctor. The baseline visit will be completed at the clinic, while the remaining visits wan be completed at the clinic, if needed, by phone. 

Initial visit (15-30 minutes). A research team member or study doctor will discuss the study with you. You will be asked to pick a loved one or someone who is close to your to participate in the study with you. This person is your care-partner. If your care-partner is with you, they will also discuss the study with a research team member. If not, we can call them by phone or send them materials for the study by email. If you do not have a care-provider, you can still join the DART study. 

Baseline visit (1 hour). The baseline visit will happen a the clinic. A research team member will ask you questions about making decisions related to your kidney disease and treatment. You will be placed in either the usual care group or the DART group at the visit. This will be decided by random 50/50 chance. People in the usual care group will receive an educational handout, "Choose a Treatment for Kidney Failure," made by the National Kidney Foundation. People in the DART group will receive the same educational handout, and will also learn how to use the DART program on the computer.

DART visit (1 hour). This visit will only happen for people in the DART group. It will happen at some point after the baseline visit and before the first follow up visit, whenever you want to do it. A research assistant will help you access and learn how to use DART on a tablet or desktop computer in the clinic. You and your care-partner can complete DART together, or separately if you have to. You may complete DART at home if you want to, in which case a research team member will call you at a scheduled time to help you access it from your computer while you are at home.

4 Follow-up Visits (45-60 minutes each). Both groups, the usual care group and the DART group, will be asked to complete four follow-up visits with their care-partners. These visits will take place at 3 months, 6 months, 12 months and 18 months after the baseline visit. You and your care-partner will be asked questions about your experiences making decisions regarding kidney disease treatment, your goals of medical care, and views about your health. These visits can be completed over the phone if necessary. You can bring your care-partner with you to these visits, or your care-partner can answer questions by phone at another time. 

People are expected to participate in this study for 18 months.