Infantile Spasms, Non-Intractable Clinical Trial
Official title:
Decreasing Parental Stress and Costs While Improving Overall Satisfaction of Caregivers of Infants With Infantile Spasms on ACTH Therapy Utilizing Innovative Telemedicine Technology: A Randomized Study
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | October 30, 2023 |
Est. primary completion date | October 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 31 Days to 30 Months |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Colorado | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | Mallinckrodt |
United States,
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* Note: There are 29 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compare parental stress between intervention group and control group | Parental stress will be measures by the Pediatric Inventory for Parents (PIP), a previously validated survey. The PIP is scored separately for each of the 4 domains (Communication, Emotional Distress, Medical Care, Role Function), across 2 scales: Frequency (F) and Difficulty (D). The range for each of the scales is 42-210, with a higher score on either scale indicating more stress. | At study enrollment (prior to hospital discharge) | |
Primary | Compare parental stress between intervention group and control group | Parental stress will be measures by the Pediatric Inventory for Parents (PIP), a previously validated survey. The PIP is scored separately for each of the 4 domains (Communication, Emotional Distress, Medical Care, Role Function), across 2 scales: Frequency (F) and Difficulty (D). The range for each of the scales is 42-210, with a higher score on either scale indicating more stress. | Mid-therapy (between week 2 and 3 of therapy) | |
Primary | Compare parental stress between intervention group and control group | Parental stress will be measures by the Pediatric Inventory for Parents (PIP), a previously validated survey. The PIP is scored separately for each of the 4 domains (Communication, Emotional Distress, Medical Care, Role Function), across 2 scales: Frequency (F) and Difficulty (D). The range for each of the scales is 42-210, with a higher score on either scale indicating more stress. | At therapy completion (end of week 4, with 7 days to complete) | |
Primary | Compare overall satisfaction with treatment between intervention group and control group | Overall treatment satisfaction will be measured by the Treatment Satisfaction Questionnaire for Medications, version 9 (TSQM v9) survey. This is a previously validated survey. The scores for the TSQM v9 can range from 1-100, with a higher score indicating greater satisfaction. | At therapy completion (end of week 4, with 7 days to complete) | |
Primary | Compare expenses between intervention group and control group | Caregivers will be asked to provide details on both direct and indirect costs incurred during therapy. This will be measured by collecting both healthcare utilizations rates, actual out-of-pocket expenses, and lost productivity measures. Combined direct and indirect expenses will be combined and compared. | At mid-therapy (between week 2 and 3 of therapy) | |
Primary | Compare expenses between intervention group and control group | Caregivers will be asked to provide details on both direct and indirect costs incurred during therapy. This will be measured by collecting both healthcare utilizations rates, actual out-of-pocket expenses, and lost productivity measures. Combined direct and indirect expenses will be combined and compared. | At therapy completion (end of week 4, with 7 days to complete) |