Recruiting

Telemedicine Technology

Sponsor:

University of Colorado, Denver

Code:

NCT04086992

Conditions

Infantile Spasms, Non-Intractable

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

Interventions

Remote monitoring

Study Details

Brief 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

Study ID

NCT04086992

Start date

Oct 10, 2019

Status verified date

May, 2022

Completion date

Oct 30, 2023

Anticipated

Primary completion date

Oct 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients admitted to CHCO, Anschutz and Colorado Springs hospitals, under the age of 30 months with a primary diagnosis of Infantile Spasms and started on first-time ACTH and their primary caregiver (parent/guardian).

Exclusion Criteria:

  • Infants with recurrent Infantile Spasms and retreatment with ACTH and their primary caregiver (parent/guardian).
  • Infants with existing home health nursing services and their primary caregiver (parent/guardian).
  • Infants with prolonged inpatient admissions beyond 7 days after initiation on ACTH and their primary caregiver (parent/guardian).
  • Infants whose caregivers do not read, write, and/or speak English with sufficient proficiency to provide informed consent and their primary caregiver (parent/guardian).
  • Neonates less than 31 days old and their primary caregiver (parent/guardian).
  • Infants that have been hospitalized since birth and their primary caregiver (parent/guardian).
  • Infants that are wards of the state and their primary caregiver (guardian).
  • Infants that reside in a geographic location with no major network cell service and their primary caregiver (parent/guardian).

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Control Group

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.

experimental: Intervention Group

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.

Interventions

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.

Primary outcome measure

  • Compare parental stress between intervention group and control group [ Time Frame: At study enrollment (prior to hospital discharge) ]
  • Compare parental stress between intervention group and control group [ Time Frame: Mid-therapy (between week 2 and 3 of therapy) ]
  • Compare parental stress between intervention group and control group [ Time Frame: At therapy completion (end of week 4, with 7 days to complete) ]
  • Compare overall satisfaction with treatment between intervention group and control group [ Time Frame: At therapy completion (end of week 4, with 7 days to complete) ]
  • Compare expenses between intervention group and control group [ Time Frame: At mid-therapy (between week 2 and 3 of therapy) ]
  • Compare expenses between intervention group and control group [ Time Frame: At therapy completion (end of week 4, with 7 days to complete) ]

Central Contacts and Locations

Central contacts

Clinical Practice Specialist

720-777-6915jennifer.coffman@childrenscolorado.org

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Jennifer D Coffman, BSN

720-777-6915jennifer.coffman@childrenscolorado.org

Principal Investigator:

Jennifer D Coffman, BSN

More Information

Sponsor

University of Colorado, Denver

Last update posted

May 4, 2022

Last verified

May, 2022

Keywords

  • Infantile Spasms
  • parental stress
  • ACTH
  • remote monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2022-05-04.