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

NCT06189807 | Active Not Recruiting

• 2 other identifiers: HUM002337871K23DK123413-01A1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

CKD; Chronic Kidney Diseases

Keywords

Pregnancy and Contraception education

Outcome Measures

Primary Outcomes (1)

• Preparation for Decision Making (PrepDM) score at post-intervention

  This is a 10-item survey that participants answer not at all (1) to a great deal (5). PrepDM is scored on a 0-100 scale, where higher score indicates better preparation for decision making. A score of \>75 is a clinically significant cut off that indicates participants being well prepared to make decisions after reviewing a DA.The PrepDM scale was adapted slightly to meet the needs of the target population and the developed novel decision aid.

  Day 1- 7 (post appointment with provider)

Secondary Outcomes (5)

• Feasibility of delivering a reproductive health decision aid in an academic nephrology clinic measured by proportion of approached patients that consent during screening period

  12 months (after recruitment starts)

• Feasibility of delivering a reproductive health decision aid in an academic nephrology clinic measured by the percentage of enrolled patients in the intervention clinics that providers reviewed contraception or pregnancy planning with participants during

  Day 1 (Visit at the clinic)

• Acceptability of delivering a reproductive health decision aid in a nephrology clinic -participants

  Day 1- 7 (post appointment with provider)

• Acceptability of delivering a reproductive health decision aid in a nephrology clinic- nephrologists

  12 months

• Feasibility of delivering a reproductive health decision aid in a nephrology clinic - nephrologists

  12 months

Study Arms (2)

Control Group -

OTHER

Other: Standard handout

Intervention Group - Decision aid

EXPERIMENTAL

Behavioral: Decision aid

Interventions

Decision aid BEHAVIORAL

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.

Intervention Group - Decision aid

Standard handout OTHER

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.

Control Group -

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Andrea Oliverio, MD, MSc

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Group assignment will be randomized at the clinic level to intervention decision aid (N=2 clinics) or control (N=2 clinics). Nephrologists will be trained to deliver the intervention.

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 5, 2024
• Study Start: February 14, 2024
• Primary Completion: September 24, 2025
• Study Completion (Estimated): September 25, 2026
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)