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Remote monitoring for Infantile Spasms

N/A
Waitlist Available
Led By Jennifer D Coffman, BSN
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 younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at therapy completion (end of week 4, with 7 days to complete)
Awards & highlights

Study Summary

This trial is studying whether a new telemedicine technology can help with parental stress, costs, and overall satisfaction in care for families who have children with a specific seizure type called infantile spasms.

Eligible Conditions
  • Infantile Spasms, Non-Intractable

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at therapy completion (end of week 4, with 7 days to complete)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at therapy completion (end of week 4, with 7 days to complete) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Compare expenses between intervention group and control group
Compare overall satisfaction with treatment between intervention group and control group
Compare parental stress between intervention group and control group

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
This group will be provided remote monitoring technology where they will be able to monitor blood pressure at home. In addition, they will receive a nurse-led telemedicine visit at one week and three weeks of therapy. Like the control group, they will still receive a two-week EEG and Neurology appointment.
Group II: Control GroupActive Control1 Intervention
This group will continue to receive standard care for ACTH monitoring and follow-up with includes blood pressure by the patient's PCP while on therapy, a one week nursing follow-up phone call, and a two-week EEG and Neurology appointment.

Find a Location

Who is running the clinical trial?

MallinckrodtIndustry Sponsor
201 Previous Clinical Trials
16,188 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,749 Previous Clinical Trials
2,164,020 Total Patients Enrolled
Jennifer D Coffman, BSNPrincipal InvestigatorChildren's Hospital Colorado

Media Library

Remote monitoring Clinical Trial Eligibility Overview. Trial Name: NCT04086992 — N/A
Infantile Spasms Research Study Groups: Intervention Group, Control Group
Infantile Spasms Clinical Trial 2023: Remote monitoring Highlights & Side Effects. Trial Name: NCT04086992 — N/A
Remote monitoring 2023 Treatment Timeline for Medical Study. Trial Name: NCT04086992 — N/A
~7 spots leftby May 2025
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