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Decision Aid for Infant Hydronephrosis

N/A
Waitlist Available
Led By Vijaya Vemulakonda, MD, JD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial will test a tool to help parents decide if early surgery or observation is best for infants with UPJO, to minimize risk of kidney damage and address potential risks of early surgery.

Who is the study for?
This trial is for parents aged 18-89 with infants (30 days to 2 years old) diagnosed with severe hydronephrosis due to UPJO, who are consulting at Children's Hospital Colorado. The child must have undergone or be scheduled for a MAG 3 test.Check my eligibility
What is being tested?
The study is testing a Parent Decision Aid tool designed to help parents understand and engage in decision-making about early surgery versus observation for their infant's kidney obstruction.See study design
What are the potential side effects?
Since this trial involves the use of a decision aid rather than a medical treatment, there are no direct physical side effects. However, the information provided could influence treatment decisions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Differences in the SDM-Q9 scores between arms
Secondary outcome measures
Assess differences in treatment decisions

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention Arm - Receipt of PtDAExperimental Treatment1 Intervention
Parents in the intervention arm will receive a paper decision aid prior to meeting with their health care professional about their child's treatment options for UPJO.
Group II: Control - Usual CareActive Control1 Intervention
Parents in the control arm will not receive a paper decision aid and instead will just receive usual care about their child's treatment options for UPJO.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,732 Previous Clinical Trials
2,143,483 Total Patients Enrolled
Children's Hospital ColoradoOTHER
115 Previous Clinical Trials
5,127,515 Total Patients Enrolled
Vijaya Vemulakonda, MD, JDPrincipal InvestigatorChildren's Hospital Colorado

Media Library

Intervention Arm - Receipt of PtDA Clinical Trial Eligibility Overview. Trial Name: NCT05900375 — N/A
Obstruction of the Pelviureteric Junction Research Study Groups: Control - Usual Care, Intervention Arm - Receipt of PtDA
Obstruction of the Pelviureteric Junction Clinical Trial 2023: Intervention Arm - Receipt of PtDA Highlights & Side Effects. Trial Name: NCT05900375 — N/A
Intervention Arm - Receipt of PtDA 2023 Treatment Timeline for Medical Study. Trial Name: NCT05900375 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who fulfills the qualifications to participate in this trial?

"Those hoping to enrol in this clinical trial must have obstructions of the pelviureteric junction and be between eighteen and eighty-nine years old. There are slots available for approximately 100 volunteers."

Answered by AI

Are there currently opportunities for enrolment in this experiment?

"According to the information provided on clinicaltrials.gov, this particular trial has already reached its recruitment goal and is no longer seeking participants at this present time. Initially posted on June 15th 2023 with a last update occurring 8 days prior, there are presently 12 alternative trials recruiting patients."

Answered by AI

Is the age requirement for this medical study restricted to individuals over 35 years old?

"Based on the eligibility requirements of this trial, individuals must be over 18 and under 89 in order to qualify."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Decision Aid for Parents of Infants With UPJO
2023. "Decision Aid for Parents of Infants With UPJO". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05900375.
~44 spots leftby Dec 2024
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