CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 136 enrolled
Drug / intervention
Parent-Reported Symptom Assessmentother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03849066
NCT03849066N/ACompleted

Enhancing Medication Safety in Children With Polypharmacy Using Parent- Reported Symptom Assessments

University of Colorado, Denver·observational·Posted Feb 21, 2019·Updated Feb 21, 2023

In Brief

An observational study evaluating Parent-Reported Symptom Assessment for Neurologic Disorder and 2 related conditions. Completed, enrolled 136 participants across 1 site.

Detailed Summary

This study plans to learn about how to measure symptoms (like tiredness or rash) in children with special healthcare needs who take 5 or more medications. Sometimes symptoms change in severity over time or new symptoms develop. This can happen after a new medication is started. This can also happen after the dose of an existing medication is changed. The Investigators believe that parents will be able to provide the best assessment of any symptoms that their child might be experiencing. This study asks parents to report any symptoms their child is currently experiencing.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedFeb 21, 2019
Enrollment StartApr 1, 2019
Primary CompletionAug 1, 2022
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 7.4 years ago

Interventions

Parent-Reported Symptom Assessmentother

As the basis for PRSA, the investigator will use the PediQuest Memorial Symptom Assessment Scale (PQ-MSAS), which is an adapted pediatric-specific version of the validated adult MSAS that assesses 28 physical and psychological symptoms over the past week. The study instrument is designed to be completed by a full-proxy parent, and 2 versions tailored for specific age groups are available (0-3, 3-18 years-old). Spanish versions are available for both instruments. The PQ-MSAS contains 28 symptom items, each with 4-point scores for domains of frequency, severity, and extent of bother. Based on these components, a global symptom score and individual symptom scores can be calculated (0-100 scale, with 100 being the worst).