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

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ClinicalTrials.gov Identifier: NCT04086992
Recruitment Status : Not yet recruiting
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
University of Colorado, Denver

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.


Condition or disease Intervention/treatment Phase
Infantile Spasms, Non-Intractable Other: Remote monitoring Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : September 15, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021


Arm Intervention/treatment
No Intervention: Control Group
This group will continue to receive standard care for ACTH monitoring and follow-up with includes blood pressure and blood glucose monitoring by the patient's PCP while on therapy, a one week nursing follow-up phone call, and a two-week EEG and Neurology appointment.
Experimental: Intervention Group
This group will be provided remote monitoring technology where they will be able to monitor blood pressure and blood glucose 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
Caregivers will be able to monitor blood pressure and blood glucose 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 Measures :
  1. Compare parental stress between intervention group and control group [ Time Frame: At study enrollment (prior to hospital discharge) ]
    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.

  2. Compare parental stress between intervention group and control group [ Time Frame: Mid-therapy (between week 2 and 3 of therapy) ]
    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.

  3. Compare parental stress between intervention group and control group [ Time Frame: At therapy completion (end of week 4, with 7 days to complete) ]
    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.

  4. Compare overall satisfaction with treatment between intervention group and control group [ Time Frame: At therapy completion (end of week 4, with 7 days to complete) ]
    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.

  5. Compare expenses between intervention group and control group [ Time Frame: At mid-therapy (between week 2 and 3 of therapy) ]
    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.

  6. Compare expenses between intervention group and control group [ Time Frame: At therapy completion (end of week 4, with 7 days to complete) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   31 Days to 30 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients admitted to CHCO, Anschutz Campus, 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04086992


Contacts
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Contact: Clinical Practice Specialist 720-777-6915 jennifer.coffman@childrenscolorado.org

Locations
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United States, Colorado
Children's Hospital Colorado Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Jennifer D Coffman, BSN    720-777-6915    jennifer.coffman@childrenscolorado.org   
Principal Investigator: Jennifer D Coffman, BSN         
Sponsors and Collaborators
University of Colorado, Denver
Mallinckrodt
Investigators
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Principal Investigator: Jennifer D Coffman, BSN Children's Hospital Colorado

Publications:

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04086992     History of Changes
Other Study ID Numbers: 18-0579
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
Infantile Spasms
parental stress
ACTH
remote monitoring
Additional relevant MeSH terms:
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Muscle Cramp
Spasm
Spasms, Infantile
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Epilepsy, Generalized
Epilepsy
Brain Diseases
Central Nervous System Diseases
Epileptic Syndromes