UnknownNot Applicable

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

United States40 participantsStarted 2019-10-10

Plain-language 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.

Who can participate

Age range

31 Days – 30 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Compare parental stress between intervention group and control group

Timeframe: At study enrollment (prior to hospital discharge)

Compare parental stress between intervention group and control group

Timeframe: Mid-therapy (between week 2 and 3 of therapy)

Compare parental stress between intervention group and control group

Timeframe: At therapy completion (end of week 4, with 7 days to complete)

Compare overall satisfaction with treatment between intervention group and control group

Timeframe: At therapy completion (end of week 4, with 7 days to complete)

Compare expenses between intervention group and control group

Timeframe: At mid-therapy (between week 2 and 3 of therapy)

Compare expenses between intervention group and control group

Timeframe: At therapy completion (end of week 4, with 7 days to complete)

Trial details

NCT IDNCT04086992

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-30

Contact for this trial

Clinical Practice Specialist

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

View on ClinicalTrials.gov More Infantile Spasms, Non-Intractable trials

Plain-language summary

Who can participate

Age range

31 Days – 30 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Compare parental stress between intervention group and control group

Timeframe: At study enrollment (prior to hospital discharge)

Compare parental stress between intervention group and control group

Timeframe: Mid-therapy (between week 2 and 3 of therapy)

Compare parental stress between intervention group and control group

Timeframe: At therapy completion (end of week 4, with 7 days to complete)

Compare overall satisfaction with treatment between intervention group and control group

Timeframe: At therapy completion (end of week 4, with 7 days to complete)

Compare expenses between intervention group and control group

Timeframe: At mid-therapy (between week 2 and 3 of therapy)

Compare expenses between intervention group and control group

Timeframe: At therapy completion (end of week 4, with 7 days to complete)