CKDPACE-CKDNCT06189807
Pregnancy and Contraception Education in Chronic Kidney Disease (PACE-CKD)
A study testing Decision aid and Standard handout in people with CKD and Chronic Kidney Diseases, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- CKD, Chronic Kidney Diseases
- What is being tested?
- Decision aid and Standard handout
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2024to 25 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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:
- Glomerular filtration rate (GFR)<60 milliliter/Minute (ml/min)/1.73m2, or
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pregnancy and Contraception Education in Chronic Kidney Disease (PACE-CKD): A Pilot Study
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.
Read the detailed 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.
- Conditions
- CKD, Chronic Kidney Diseases
- Being tested
- Decision aid, Standard handout
- Keywords
- Pregnancy and Contraception education
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision aidBehavioural
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 handoutOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group - | Other | Not described Receives: Other: Standard handout |
| Intervention Group - Decision aid | Experimental | Not described Receives: Behavioral: Decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: Day 1 (Visit at the clinic)
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.
Measured: Day 1- 7 (post appointment with provider)
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start14 Feb 2024
- Primary completion24 Sep 2025
- Study completion25 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKDStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Oliverio, University of Michigan
- Investigators
- Andrea Oliverio, MD, MSc, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189807
- Sponsor's protocol ID
- HUM00233787
- Other IDs
- 1K23DK123413-01A1
- Acronym
- PACE-CKD
- Status last verified
- Nov 2025
- First submitted
- 18 Dec 2023
- Last updated
- 12 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy and Contraception Education in Chronic Kidney Disease (PACE-CKD): A Pilot Study
- ClinicalTrials.gov ID
- NCT06189807
- Acronym / sponsor ID
- PACE-CKD / HUM00233787
- Conditions
- CKD, Chronic Kidney Diseases
- Keywords
- Pregnancy and Contraception education
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 24 Sep 2025 (actual)
- Study completion
- 25 Sep 2026 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group - | Other | Other: Standard handout |
| Intervention Group - Decision aid | Experimental | Behavioral: Decision aid |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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:
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision aidEnrolled 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. | Behavioural | Intervention Group - Decision aid |
| Standard handoutEnrolled 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. | Other | Control Group - |
Primary outcome
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.
5 secondary outcomes
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)
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)
Acceptability of delivering a reproductive health decision aid in a nephrology clinic -participants
Time frame: Day 1- 7 (post appointment with provider)
Acceptability of delivering a reproductive health decision aid in a nephrology clinic- nephrologists
Time frame: 12 months
Feasibility of delivering a reproductive health decision aid in a nephrology clinic - nephrologists
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Oliverio, MD, MSc principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision aid and Standard handout in people with CKD and Chronic Kidney Diseases, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preparation for Decision Making (PrepDM) score at post-intervention (time frame: Day 1- 7 (post appointment with provider)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.