N/A
N=136
Parent-Reported Symptom Assessments in Children Taking Multiple Medications
Neurologic Disorder · Chronic Disease · Pediatric Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03849066 ↗Enrolled (actual)
136
Serious AEs
—
Results posted
Feb 2023
Primary outcome: Primary: Global Symptom Score — 12.1 score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Parent-Reported Symptom Assessment (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Global Symptom Score |
12.1 | — |
| SECONDARY Medication Count |
25; 44; 54 | — |
| SECONDARY Medication Regimen Complexity Index Score (MRCI) |
46 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Neurological impairment
- 5 or more scheduled medications
- English- or Spanish-speaking
Exclusion Criteria
- Receives primary care outside outside of the Children's Hospital Colorado Network of Care
Data sourced from ClinicalTrials.gov (NCT03849066). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.