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

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.

Conditions

• CKD
• Chronic Kidney Diseases

Interventions

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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• University of Michigan

  lead OTHER

Principal Investigators

• Andrea Oliverio, MD, MSc · University of Michigan

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-14

Primary Completion

2025-09-24

Completion

2026-09-25

Countries

• United States

Study Locations