Education on pregnancy and contraception for patients with chronic kidney disease
Pregnancy and Contraception Education in Chronic Kidney Disease (PACE-CKD): A Pilot Study
This study is testing a new educational tool to help patients with chronic kidney disease learn about pregnancy and contraception options to see if it’s more helpful than regular information.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06189807 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the effectiveness of a decision aid designed to educate patients with chronic kidney disease (CKD) about pregnancy and contraception options. Sixty participants will be randomly assigned to receive either the novel decision aid delivered by their nephrologist or standard educational materials. The study aims to assess the feasibility and acceptability of this intervention, with participants completing surveys regarding their decision-making process and the educational materials provided. Nephrologists involved in the intervention will also provide feedback on the acceptability and feasibility of the decision aid after patient interactions.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with chronic kidney disease who are able to read and speak English.
Not a fit: Patients receiving dialysis, those who have had a kidney transplant, or individuals who are currently pregnant or surgically sterile will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could empower patients with CKD to make informed reproductive health decisions.
How similar studies have performed: While this approach is innovative, similar studies focusing on patient education in chronic conditions have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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)
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Andrea Oliverio, MD, MSc — University of Michigan
- Study coordinator: Kelcie Brophy
- Email: kelcieb@umich.edu
- Phone: 734-615-0531
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.