NCT06189807

Pregnancy and Contraception Education in Chronic Kidney Disease (PACE-CKD)

Pregnancy and Contraception Education in Chronic Kidney Disease (PACE-CKD): A Pilot Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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 assess feasibility and acceptability of the intervention to inform future Research Project Grant (R01) level studies.

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 materials based on clinic-level randomization. Nephrologists will be trained to deliver the novel decision aid or will provide usual care. Patients will complete a survey about pregnancy and contraception decision making and the acceptability and feasibility of the educational materials after the clinical visit. Intervention nephrologists will be anonymously surveyed after all patients have completed measures, to assess acceptability and feasibility.

Conditions

• CKD
• Chronic Kidney Diseases

Interventions

Type	Name	Description
BEHAVIORAL	Decision aid	Enrolled participants will be sent the novel educational decision aid about pregnancy, birth control, and kidney disease and asked to read that information prior to a standard of care appointment with participants nephrologist. Prior to the appointment, study staff will provide participants with a paper version of the materials that had previously been sent. During the appointment participant's nephrologist may review the materials with the participant and answer any questions. Following the appointment, participants will be asked to complete a short survey about: the experience using the materials, experience about being counseled about pregnancy and birth control during visit, willingness to use such materials in the future, and information about participants kidney disease diagnosis.
OTHER	Standard handout	Enrolled participants will be sent the standard information about pregnancy, birth control, and kidney disease and asked to read that information prior to a standard of care appointment with participants nephrologist. Prior to the appointment study staff will provide participants with a paper version of the materials that had previously been sent. During the appointment, the participant's nephrologist may review the materials with the participant and answer any questions. Following the appointment, participants will be asked to complete a short survey about: the experience using the materials, experience about being counseled about pregnancy and birth control during visit, willingness to use such materials in the future, and information about participants kidney disease diagnosis.

Timeline

• Start date: 2024-02-14
• Primary completion: 2025-09-24
• Completion: 2026-09-25
• First posted: 2024-01-05
• Last updated: 2025-11-12

Locations

1 site across 1 country: United States