Status:
ACTIVE_NOT_RECRUITING
Pregnancy and Contraception Education in Chronic Kidney Disease (PACE-CKD)
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
CKD
Chronic Kidney Diseases
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
This pilot study will assess the efficacy of a pregnancy and contraception education decision aid (DA) for patients with chronic kidney disease to support decisions about reproductive health, and will...
Detailed Description
60 patient participants will receive either a novel DA about pregnancy and contraception in chronic kidney disease delivered by patient's nephrologist or will receive currently available educational m...
Eligibility Criteria
Inclusion
- Any Chronic Kidney Disease (CKD) diagnosis
- CKD defined as abnormality in kidney structure or function for \>3 months and may be manifested by having any one of the following:
- i. Glomerular filtration rate (GFR)\<60 milliliter/Minute (ml/min)/1.73m2, or
- ii. A marker of kidney damage (albuminuria \>30 milligrams per gram (mg/g), abnormal kidney histology by biopsy, hematuria, structural abnormalities by imaging (e.g. polycystic kidney disease, horseshoe kidney) or electrolyte abnormalities due to tubular disorders)
- \- Able to speak and read English
Exclusion
- Patients receiving dialysis
- Patients who have a kidney transplant
- Patients that are surgically sterile (tubal ligation or hysterectomy) or currently pregnant
- Patients that have significant cognitive or visual impairment that limits interaction with the decision aid (DA)
Key Trial Info
Start Date :
February 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 25 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06189807
Start Date
February 14 2024
End Date
September 25 2026
Last Update
November 12 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Michigan
Ann Arbor, Michigan, United States, 48109