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

NCT04086992 | Unknown

• 1 other identifier: 18-0579
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Infantile Spasms; parental stress; ACTH; remote monitoring

Outcome Measures

Primary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Control Group

NO INTERVENTION

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.

Intervention Group

EXPERIMENTAL

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.

Other: Remote monitoring

Interventions

Remote monitoring 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.

Intervention Group

Eligibility Criteria

• Age: 31 Days - 30 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Mallinckrodt: collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Related Publications (29)

• 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.

  PMID: 26704170 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.

  PMID: 20726878 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.

  PMID: 27293335 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.

  PMID: 25524855 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.

  PMID: 19435579 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.

  PMID: 16239177 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.

  PMID: 22689735 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.

  PMID: 20691936 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.

  PMID: 28917500 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.

  PMID: 15602179 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.

  PMID: 26195452 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.

  PMID: 18337182 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.

  PMID: 18182646 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.

  PMID: 18977459 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.

  PMID: 26857383 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.

  PMID: 27451860 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.

  PMID: 26355126 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.

  PMID: 23663957 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.

  PMID: 26996767 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.

  PMID: 28839936 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.

  PMID: 8727439 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.

  PMID: 3588145 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.

  PMID: 7197478 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.

  PMID: 3681356 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.

  PMID: 2340688 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.

  PMID: 6624679 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.

  PMID: 12048430 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.

  PMID: 18622232 BACKGROUND

• 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.

  PMID: 29192011 BACKGROUND

MeSH Terms

Conditions

Spasms, Infantile

Interventions

Remote Patient Monitoring

Condition Hierarchy (Ancestors)

Epilepsy, Generalized; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Intervention Hierarchy (Ancestors)

Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Jennifer D Coffman, BSN

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Practice Specialist

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: September 12, 2019
• Study Start: October 10, 2019
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: May 4, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)