Decreasing Parental Stress of Caregivers of Infants With Infantile Spasms by Using Telemedicine Technology
NCT ID: NCT04086992
Last Updated: 2022-05-04
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
40 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-10-10
Study Completion Date
2023-10-30
Brief Summary
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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.
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.
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Detailed Description
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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:
1. 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.
2. 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.
3. 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:
1. 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.
2. 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.
3. EEG follow-up at 2 weeks of therapy - results are sent to primary neurologist.
4. 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:
1. 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.
2. 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.
3. 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.
4. EEG follow-up at 2 weeks of therapy - results are sent to primary neurologist.
5. Neurology appointment at 2 weeks of therapy
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:
1. 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.
2. 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.
3. 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:
1. 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.
2. 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.
3. EEG follow-up at 2 weeks of therapy - results are sent to primary neurologist.
4. 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:
1. 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.
2. 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.
3. 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.
4. EEG follow-up at 2 weeks of therapy - results are sent to primary neurologist.
5. Neurology appointment at 2 weeks of therapy
Conditions
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Infantile Spasms, Non-Intractable
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Study Groups
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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.
Group Type
NO_INTERVENTION
No interventions assigned to this group
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.
Group Type
EXPERIMENTAL
Remote monitoring
Intervention Type
OTHER
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.
Interventions
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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.
Intervention Type
OTHER
Eligibility Criteria
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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).
* 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).
Minimum Eligible Age
31 Days
Maximum Eligible Age
30 Months
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Mallinckrodt
INDUSTRY
Sponsor Role
collaborator
University of Colorado, Denver
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Jennifer D Coffman, BSN
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Colorado
Locations
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Children's Hospital Colorado
Aurora, Colorado, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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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.
Reference Type
BACKGROUND
DeAlleaume L, Parnes B, Zittleman L, Sutter C, Chavez R, Bernstein J, LeBlanc W, Dickinson M, Westfall JM. Success in the Achieving CARdiovascular Excellence in Colorado (A CARE) Home Blood Pressure Monitoring Program: A Report from the Shared Networks of Colorado Ambulatory Practices and Partners (SNOCAP). J Am Board Fam Med. 2015 Sep-Oct;28(5):548-55. doi: 10.3122/jabfm.2015.05.150024.
Reference Type
BACKGROUND
Siehr SL, Norris JK, Bushnell JA, Ramamoorthy C, Reddy VM, Hanley FL, Wright GE. Home monitoring program reduces interstage mortality after the modified Norwood procedure. J Thorac Cardiovasc Surg. 2014 Feb;147(2):718-23.e1. doi: 10.1016/j.jtcvs.2013.04.006. Epub 2013 May 8.
Reference Type
BACKGROUND
Ladapo JA, Turakhia MP, Ryan MP, Mollenkopf SA, Reynolds MR. Health Care Utilization and Expenditures Associated With Remote Monitoring in Patients With Implantable Cardiac Devices. Am J Cardiol. 2016 May 1;117(9):1455-62. doi: 10.1016/j.amjcard.2016.02.015. Epub 2016 Feb 17.
Reference Type
BACKGROUND
Robinson JD, Prochaska JD, Yngve DA. Pre-surgery evaluations by telephone decrease travel and cost for families of children with cerebral palsy. SAGE Open Med. 2017 Jul 23;5:2050312117720046. doi: 10.1177/2050312117720046. eCollection 2017.
Reference Type
BACKGROUND
Gevers M, van Genderingen HR, Lafeber HN, Hack WW. Accuracy of oscillometric blood pressure measurement in critically ill neonates with reference to the arterial pressure wave shape. Intensive Care Med. 1996 Mar;22(3):242-8. doi: 10.1007/BF01712244.
Reference Type
BACKGROUND
Park MK, Menard SM. Accuracy of blood pressure measurement by the Dinamap monitor in infants and children. Pediatrics. 1987 Jun;79(6):907-14.
Reference Type
BACKGROUND
Friesen RH, Lichtor JL. Indirect measurement of blood pressure in neonates and infants utilizing an automatic noninvasive oscillometric monitor. Anesth Analg. 1981 Oct;60(10):742-5.
Reference Type
BACKGROUND
Cullen PM, Dye J, Hughes DG. Clinical assessment of the neonatal Dinamap 847 during anesthesia in neonates and infants. J Clin Monit. 1987 Oct;3(4):229-34. doi: 10.1007/BF03337376.
Reference Type
BACKGROUND
Chia F, Ang AT, Wong TW, Tan KW, Fung KP, Lee J, Khin K. Reliability of the Dinamap non-invasive monitor in the measurement of blood pressure of ill Asian newborns. Clin Pediatr (Phila). 1990 May;29(5):262-7. doi: 10.1177/000992289002900502.
Reference Type
BACKGROUND
Colan SD, Fujii A, Borow KM, MacPherson D, Sanders SP. Noninvasive determination of systolic, diastolic and end-systolic blood pressure in neonates, infants and young children: comparison with central aortic pressure measurements. Am J Cardiol. 1983 Oct 1;52(7):867-70. doi: 10.1016/0002-9149(83)90430-7.
Reference Type
BACKGROUND
Nelson RM, Stebor AD, Groh CM, Timoney PM, Theobald KS, Friedman BA. Determination of accuracy in neonates for non-invasive blood pressure device using an improved algorithm. Blood Press Monit. 2002 Apr;7(2):123-9. doi: 10.1097/00126097-200204000-00006.
Reference Type
BACKGROUND
Stergiou GS, Nasothimiou E, Giovas P, Kapoyiannis A, Vazeou A. Diagnosis of hypertension in children and adolescents based on home versus ambulatory blood pressure monitoring. J Hypertens. 2008 Aug;26(8):1556-62. doi: 10.1097/HJH.0b013e328301c411.
Reference Type
BACKGROUND
Knupp KG, Coryell J, Nickels KC, Ryan N, Leister E, Loddenkemper T, Grinspan Z, Hartman AL, Kossoff EH, Gaillard WD, Mytinger JR, Joshi S, Shellhaas RA, Sullivan J, Dlugos D, Hamikawa L, Berg AT, Millichap J, Nordli DR Jr, Wirrell E; Pediatric Epilepsy Research Consortium. Response to treatment in a prospective national infantile spasms cohort. Ann Neurol. 2016 Mar;79(3):475-84. doi: 10.1002/ana.24594. Epub 2016 Feb 13.
Reference Type
BACKGROUND
Osborne JP, Lux AL, Edwards SW, Hancock E, Johnson AL, Kennedy CR, Newton RW, Verity CM, O'Callaghan FJ. The underlying etiology of infantile spasms (West syndrome): information from the United Kingdom Infantile Spasms Study (UKISS) on contemporary causes and their classification. Epilepsia. 2010 Oct;51(10):2168-74. doi: 10.1111/j.1528-1167.2010.02695.x. Epub 2010 Aug 17.
Reference Type
BACKGROUND
Iype M, Saradakutty G, Kunju PA, Mohan D, Nair MK, George B, Ahamed SM. Infantile spasms: A prognostic evaluation. Ann Indian Acad Neurol. 2016 Apr-Jun;19(2):228-35. doi: 10.4103/0972-2327.173314.
Reference Type
BACKGROUND
Widjaja E, Go C, McCoy B, Snead OC. Neurodevelopmental outcome of infantile spasms: A systematic review and meta-analysis. Epilepsy Res. 2015 Jan;109:155-62. doi: 10.1016/j.eplepsyres.2014.11.012. Epub 2014 Nov 22.
Reference Type
BACKGROUND
Kossoff EH, Hartman AL, Rubenstein JE, Vining EP. High-dose oral prednisolone for infantile spasms: an effective and less expensive alternative to ACTH. Epilepsy Behav. 2009 Apr;14(4):674-6. doi: 10.1016/j.yebeh.2009.01.023. Epub 2009 Feb 4.
Reference Type
BACKGROUND
Lux AL, Edwards SW, Hancock E, Johnson AL, Kennedy CR, Newton RW, O'Callaghan FJ, Verity CM, Osborne JP; United Kingdom Infantile Spasms Study. The United Kingdom Infantile Spasms Study (UKISS) comparing hormone treatment with vigabatrin on developmental and epilepsy outcomes to age 14 months: a multicentre randomised trial. Lancet Neurol. 2005 Nov;4(11):712-7. doi: 10.1016/S1474-4422(05)70199-X.
Reference Type
BACKGROUND
Go CY, Mackay MT, Weiss SK, Stephens D, Adams-Webber T, Ashwal S, Snead OC 3rd; Child Neurology Society; American Academy of Neurology. Evidence-based guideline update: medical treatment of infantile spasms [RETIRED]. Report of the Guideline Development Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society. Neurology. 2012 Jun 12;78(24):1974-80. doi: 10.1212/WNL.0b013e318259e2cf.
Reference Type
BACKGROUND
Wray CD, Benke TA. Effect of price increase of adrenocorticotropic hormone on treatment practices of infantile spasms. Pediatr Neurol. 2010 Sep;43(3):163-6. doi: 10.1016/j.pediatrneurol.2010.04.005.
Reference Type
BACKGROUND
Ibrahim A, Umar UI, Usman UM, Owolabi LF. Economic evaluation of childhood epilepsy in a resource-challenged setting: A preliminary survey. Epilepsy Behav. 2017 Nov;76:84-88. doi: 10.1016/j.yebeh.2017.08.023. Epub 2017 Sep 13.
Reference Type
BACKGROUND
Burton WN, Chen CY, Conti DJ, Pransky G, Edington DW. Caregiving for ill dependents and its association with employee health risks and productivity. J Occup Environ Med. 2004 Oct;46(10):1048-56. doi: 10.1097/01.jom.0000141830.72507.32.
Reference Type
BACKGROUND
Bator EX, Gleason JM, Lorenzo AJ, Kanaroglou N, Farhat WA, Bagli DJ, Koyle MA. The burden of attending a pediatric surgical clinic and family preferences toward telemedicine. J Pediatr Surg. 2015 Oct;50(10):1776-82. doi: 10.1016/j.jpedsurg.2015.06.005. Epub 2015 Jun 20.
Reference Type
BACKGROUND
Wirrell EC, Wood L, Hamiwka LD, Sherman EM. Parenting stress in mothers of children with intractable epilepsy. Epilepsy Behav. 2008 Jul;13(1):169-73. doi: 10.1016/j.yebeh.2008.02.011. Epub 2008 Mar 11.
Reference Type
BACKGROUND
Chiou HH, Hsieh LP. Parenting stress in parents of children with epilepsy and asthma. J Child Neurol. 2008 Mar;23(3):301-6. doi: 10.1177/0883073807308712. Epub 2008 Jan 8.
Reference Type
BACKGROUND
Modi AC. The impact of a new pediatric epilepsy diagnosis on parents: parenting stress and activity patterns. Epilepsy Behav. 2009 Jan;14(1):237-42. doi: 10.1016/j.yebeh.2008.10.009. Epub 2008 Nov 26.
Reference Type
BACKGROUND
Ong MK, Romano PS, Edgington S, Aronow HU, Auerbach AD, Black JT, De Marco T, Escarce JJ, Evangelista LS, Hanna B, Ganiats TG, Greenberg BH, Greenfield S, Kaplan SH, Kimchi A, Liu H, Lombardo D, Mangione CM, Sadeghi B, Sadeghi B, Sarrafzadeh M, Tong K, Fonarow GC; Better Effectiveness After Transition-Heart Failure (BEAT-HF) Research Group. Effectiveness of Remote Patient Monitoring After Discharge of Hospitalized Patients With Heart Failure: The Better Effectiveness After Transition -- Heart Failure (BEAT-HF) Randomized Clinical Trial. JAMA Intern Med. 2016 Mar;176(3):310-8. doi: 10.1001/jamainternmed.2015.7712.
Reference Type
BACKGROUND
McElroy I, Sareh S, Zhu A, Miranda G, Wu H, Nguyen M, Shemin R, Benharash P. Use of digital health kits to reduce readmission after cardiac surgery. J Surg Res. 2016 Jul;204(1):1-7. doi: 10.1016/j.jss.2016.04.028. Epub 2016 Apr 23.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
18-0579
Identifier Type: -
Identifier Source: org_study_id
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