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

Primary Purpose

Infantile Spasms, Non-Intractable

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Remote monitoring
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infantile Spasms, Non-Intractable focused on measuring Infantile Spasms, parental stress, ACTH, remote monitoring

Eligibility Criteria

31 Days - 30 Months (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Children's Hospital ColoradoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Intervention Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 27, 2019
Last Updated
May 2, 2022
Sponsor
University of Colorado, Denver
Collaborators
Mallinckrodt
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1. Study Identification

Unique Protocol Identification Number
NCT04086992
Brief Title
Decreasing Parental Stress of Caregivers of Infants With Infantile Spasms by Using Telemedicine Technology
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Mallinckrodt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Infantile Spasms, historically call West Syndrome, is an infantile epileptic encephalopathy, typically occurring within the first two years of life. Infantile Spasms is often characterized by hypsarrhythmia on encephalogram (EEG) and developmental plateau or regression. It is estimated that Infantile Spasms affects 2 to 5 per 10,000 live births. The etiology of Infantile Spasms is varied and often unclear at the time of diagnosis. In almost half of cases it is linked to hypoxic-ischemic encephalopathy, chromosomal abnormalities, perinatal stroke, tuberous sclerosis complex, or periventricular leukomalacia or hemorrhage. While historically treatment options have been widely variable, over the past several years three pharmacologic therapies have been adopted, including ACTH, oral corticosteroids (OCS), and vigabatrin. ACTH was approved for use for multiple neurologic conditions in 1952 and specifically for Infantile Spasms in 2010. Unfortunately, as a hormone therapy, ACTH carries several potentially severe side effects including adrenal insufficiency, immunosuppression, electrolyte imbalances, and more commonly elevated blood pressure thought to lead to serious cardiac changes. Complexity of ACTH therapy requires close monitoring. ACTH is administered intramuscularly twice a day for the initial two weeks with a complicated weaning schedule over the subsequent 2 weeks. Between the required monitoring and complicated administration regimen, ACTH therapy is often overwhelming and confusing for caregivers, and can lead to medication errors. Unfortunately, primary care (PCP) monitoring for ACTH has proved to be inconsistent. Barriers for families have included: families without an identified PCP, families without the means to get to their PCP at the recommended intervals (rural location or inadequate transportation), PCP's without the correct equipment to monitor infants, limited office hours, and PCP with little comfort in managing side-effects when they present. This has resulted in disjointed care, and last-minute attempts to obtain needed monitoring in less-than-ideal settings (e.g., urgent care, hospital, neurology clinic) - all with additional expense to families. Treatment with ACTH is associated with high direct and indirect costs. Treatment of Infantile Spasms with ACTH carries a significant financial burden for families. In August 2007, the cost for one vial of ACTH, then manufactured by Questcor Pharmaceuticals and now by Mallinckrodt Pharmaceuticals, increased from $1650 to $23,000. Current, non-discounted pricing is $34,400 per vial. The average therapy calls for 3-4 vials, with a total price tag between $103,200 and $137,600. Any potential for medication error further exacerbates costs of therapy. Consumer-incurred costs of ACTH therapy have not previously been reported. Direct costs of ACTH therapy for caregivers include, at a minimum, the out-of-pocket expense for the drug as well as required PCP, neurology, and EEG follow-up. It is not uncommon, due to complications of monitoring, that caregivers sustain additional direct costs seeking monitoring in unplanned ways (e.g., urgent care/ED visits). In addition, prophylactic treatment with antibiotics and H2 blockers to combat potential side effects is necessary and adds to caregiver expense. Indirect costs include loss of productivity due to work absences and non-paid loss of productivity (e.g., homemaker). Expense of transportation and travel can also be significant. Considering the potential severe side-effects of ACTH, the complicated medication regime, the rigorous required follow-up, the costs inherent in the therapy alone and those due to complications, it is hypothesized that parenting stress for parents of babies with IS is high. Support for these families is critical to successful ACTH therapy. Historically at Children's Hospital Colorado, there has been no structured support outside of the initial admission for diagnosis/start of therapy and follow-up neurology appointments. This study is intended to explore and compare parenting stress of parents/caregivers caring for babies with IS being treated with ACTH and secondarily, overall treatment satisfaction. Remote biometric monitoring led by highly skilled registered nurses could offer a novel, feasible, cost-effective strategy to support families of infants with IS during treatment with ACTH. Although there is currently no published literature exploring the use of telehealth or remote monitoring in the specific treatment of Infantile Spasms, its successful use in other complex conditions underscores its potential for benefit. In addition to optimization of disease-related outcomes, remote monitoring has high potential to reduce financial burden and parenting stress on parent/caregivers. This proposed study will utilize a prospective randomized clinical trial design. - Infants and caregivers of infants who meet the inclusion criteria will be invited to participate. They will be randomized to the intervention or usual care group in accordance with a random number generator program through the Biostatistics Core at CHCO. Randomization will be stratified by payor source. The study hypotheses include: 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. Compared to those utilizing usual monitoring, parents/caregivers of infants with IS treated with 4 weeks of ACTH utilizing nurse-led remote biometric monitoring will experience a decrease in direct (including travel) and indirect cost of care. Compared to those utilizing usual monitoring, parents/caregivers of infants with IS treated with ACTH utilizing nurse-led remote biometric monitoring will experience greater overall satisfaction with treatment. All caregivers will be given the standard education on Infantile Spasms, ACTH and ACTH administration. The control group will continue to receive standard care for ACTH monitoring and follow-up, which includes: Blood pressure monitoring by PCP recommended to occur a minimum of two times per week. Depending on the results and PCP's comfort in managing any aberrant results, the PCP may or may not share them with the patient's primary neurologist. Nurse follow-up phone call at 1 week of therapy to assess spasm frequency, monitoring and medication adherence, side-effects, complications of therapy, validate the dosing schedule, confirm required follow-up appointments (Neurology and EEG), answer any questions, and provide support. Data collected during these calls is routed to the patient's primary neurologist for review. EEG follow-up at 2 weeks of therapy - results are sent to primary neurologist. Neurology appointment at 2 weeks of therapy The intervention group will receive and be instructed on the use of a re-useable digital health kit that will include an electronic tablet with integrated monitoring and telehealth software and manual or automatic blood pressure machine with appropriate sized cuff. The software utilized is web-based and has the capability to integrate into an organization's electronic health record. It allows for the real-time monitoring by healthcare professionals and the establishment of alerts. Appropriate research personnel will be responsible for this monitoring. In addition to biometric monitoring, the software allows for individualized health and other surveys to gain immediate patient feedback. Finally, the tablet and software support video telemedicine visits in the patient home. The following interventions will be utilized in the intervention group: Caregivers will take blood pressure three times per week (ideally, Monday, Wednesday, Friday) and will uploaded into the monitoring software/tablet. A neurology nurse will monitor these results, transcribe them into the patient's medical record, and route them to the patient's primary neurologist for review and potential follow-up. Caregivers will complete a twice-a-week side-effect and adherence survey in the software/tablet. The results of this survey will be transcribed into the patient's medical record and routed to the patient's primary neurologist for review and potential follow-up. A neurology nurse will conduct a video telehealth visit with the caregiver to assess spasm frequency, monitoring and medication adherence, side-effects, complications of therapy, validate the dosing schedule, confirm required follow-up appointments (Neurology and EEG), answer any questions, and provide support between days 7-10 and again between days 21-24 of therapy. This will be documented as a telehealth nurse-visit and routed to the patient's primary neurologist for review and potential follow-up. EEG follow-up at 2 weeks of therapy - results are sent to primary neurologist. Neurology appointment at 2 weeks of therapy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infantile Spasms, Non-Intractable
Keywords
Infantile Spasms, parental stress, ACTH, remote monitoring

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients with infantile spasms will be randomized into either the control group that will receive traditional follow-up or the intervention group that will receive remote monitoring for follow-up. Both groups will complete surveys to collect data on parental stress, direct and indirect costs, and overall satisfaction with therapy.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Remote monitoring
Intervention Description
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 Information:
Title
Compare parental stress between intervention group and control group
Description
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.
Time Frame
At study enrollment (prior to hospital discharge)
Title
Compare parental stress between intervention group and control group
Description
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.
Time Frame
Mid-therapy (between week 2 and 3 of therapy)
Title
Compare parental stress between intervention group and control group
Description
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.
Time Frame
At therapy completion (end of week 4, with 7 days to complete)
Title
Compare overall satisfaction with treatment between intervention group and control group
Description
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.
Time Frame
At therapy completion (end of week 4, with 7 days to complete)
Title
Compare expenses between intervention group and control group
Description
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.
Time Frame
At mid-therapy (between week 2 and 3 of therapy)
Title
Compare expenses between intervention group and control group
Description
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.
Time Frame
At therapy completion (end of week 4, with 7 days to complete)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
31 Days
Maximum Age & Unit of Time
30 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Practice Specialist
Phone
720-777-6915
Email
jennifer.coffman@childrenscolorado.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer D Coffman, BSN
Organizational Affiliation
Children's Hospital Colorado
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer D Coffman, BSN
Phone
720-777-6915
Email
jennifer.coffman@childrenscolorado.org
First Name & Middle Initial & Last Name & Degree
Jennifer D Coffman, BSN

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share IPD.
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Flynn JT, Kaelber DC, Baker-Smith CM, et al; SUBCOMMITTEE ON SCREENING AND MANAGEMENT OF HIGH BLOOD PRESSURE IN CHILDREN. Clinical Practice Guideline for Screening and Management of High Blood Pressure in Children and Adolescents. Pediatrics. 2017; 140(3):e20171904. Pediatrics. 2017 Dec;140(6):e20173035. doi: 10.1542/peds.2017-3035. No abstract available.
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Decreasing Parental Stress of Caregivers of Infants With Infantile Spasms by Using Telemedicine Technology

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