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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
No Placebo-Only Group
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ at therapy completion (end of week 4, with 7 days to complete)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at therapy completion (end of week 4, with 7 days to complete)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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Who is running the clinical trial?
MallinckrodtIndustry Sponsor
201 Previous Clinical Trials
15,826 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,802 Previous Clinical Trials
2,822,072 Total Patients Enrolled
Jennifer D Coffman, BSNPrincipal InvestigatorChildren's Hospital Colorado
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Babies who have had repeated episodes of Infantile Spasms and have been treated with ACTH, along with their main caregiver (parent or guardian).
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Group
- Group 2: Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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