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

Recruiting
18 - 45 years of age
Female
Phase N/A

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Overview

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.

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.

Eligibility

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)
          -  New patient (NP) visit appointment type

Study details

CKD, Chronic Kidney Diseases

NCT06189807

University of Michigan

8 June 2024

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