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

Chronic Kidney Diseases Clinical Trial

— PACE-CKD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06189807
• Other study ID #: HUM00233787
• Secondary ID: 1K23DK123413-01A
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2024
• Est. completion date: February 2026

Study information

• Verified date: May 2024
• Source: University of Michigan
• Contact: Kelcie Brophy
• Phone: 734-615-0531
• Email: kelcieb[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: February 2026
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• CKD
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	Acceptability of delivering a reproductive health decision aid in a nephrology clinic -participants	Acceptability of using the shared decision aid will be assessed by 8 questions and analyzed descriptively.	Day 1- 7 (post appointment with provider)
Secondary	Acceptability of delivering a reproductive health decision aid in a nephrology clinic- nephrologists	Acceptability of using the shared decision aid will be assessed by 2 questions and analyzed descriptively.	12 months
Secondary	Feasibility of delivering a reproductive health decision aid in a nephrology clinic - nephrologists	Feasibility of using the shared decision aid will be assessed by 2 questions and analyzed descriptively.	12 months