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

University of Michigan

Status

Enrolling

Conditions

Chronic Kidney Diseases

CKD

Treatments

Other: Standard handout

Behavioral: Decision aid

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06189807

1K23DK123413-01A1 (U.S. NIH Grant/Contract)

HUM00233787

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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)