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Active, Not Recruiting

NCT Number: NCT06189807

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: Day 1- 7 (post appointment with provider)

    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.

Secondary outcomes

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

    Time frame: 12 months (after recruitment starts)

  2. 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

    Time frame: Day 1 (Visit at the clinic)

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

    Time frame: Day 1- 7 (post appointment with provider)

    Acceptability of using the shared decision aid will be assessed by 8 questions and analyzed descriptively.

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

    Time frame: 12 months

    Acceptability of using the shared decision aid will be assessed by 2 questions and analyzed descriptively.

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

    Time frame: 12 months

    Feasibility of using the shared decision aid will be assessed by 2 questions and analyzed descriptively.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

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

Registry information

Official study title

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

Acronym: PACE-CKD

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 5, 2024
Registry last updated
Nov 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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