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Decreasing Parental Stress of Caregivers of Infants With Infantile Spasms by Using Telemedicine Technology

NCT04086992 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-05-04

No results posted yet for this study

Summary

This study plans to learn more about how the use of new telemedicine technology can help with parental stress, costs, and overall satisfaction in care. Investigators are studying this in families who have children with a specific seizure type called infantile spasms and being treated with a medication called ACTH (adrenocorticotropic hormone). Infantile spasms is a rare epileptic encephalopathy that occurs within the first two years of life. It is associated with complicated and expensive treatment and poor developmental outcomes. Participants will be randomly placed in one of two groups. The first group will continue with the traditional monitoring practices primarily performed by their pediatrician. The second group will use telemedicine technology to be monitored. Investigators will then compare the two groups to see if there are any differences in parental stress, costs of care, and/or overall satisfaction with care.

The primary hypothesis is that compared to those utilizing usual monitoring, parents/caregivers of infants with IS treated with ACTH utilizing nurse-led remote biometric monitoring will report less parenting stress at 2 and 4 weeks of treatment.

Conditions

  • Infantile Spasms, Non-Intractable

Interventions

OTHER

Remote monitoring

Caregivers will be able to monitor blood pressure from home and upload in a cloud-based application on a hand-held tablet. In addition, this technology will administer surveys to the caregiver to assess for therapy side effects and adherence. Nurse-led telemedicine visits will also be utilized. The healthcare team will be able to monitor these parameters remotely.

Sponsors & Collaborators

  • Mallinckrodt

    collaborator INDUSTRY

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Jennifer D Coffman, BSN · Children's Hospital Colorado

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
31 Days
Max Age
30 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-10
Primary Completion
2023-10-30
Completion
2023-10-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04086992 on ClinicalTrials.gov