An interventional study of Daily Messages, Virtual Home Visits and Usual Care in Congenital Heart Disease and Post Cardiac Surgery, sponsored by Children's Hospital of Philadelphia. Completed at 2 sites in United States. Open to participants aged 2 Weeks to 5 Months. Per ClinicalTrials.gov, last updated 2017-10-03.
Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Supportive care
The investigators want to determine if additional, increased contact with infants and families discharged to home after cardiac surgery improves infant and parent outcomes as compared to usual care.
The investigators want to compare videoconferencing (SKYPE or FACTIME) and a monitoring system called Buddy Check is helpful. Buddy Check is a web-based tool using speech and internet technology to maintain contact with the health care team.
Infants are randomized to usual care or the intervention which uses automated daily phone calls and 2 virtual home visits each week. Weights, oxygen levels, and amount of food taken are obtained by the primary caregiver (parent) daily and sent via automated phone call, text message or email messages based on primary caregiver's desired.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 218 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →Children's Hospital of Philadelphia is the lead sponsor of 480 studies on the registry; 85 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intervention includes: Measuring daily weights, 24 hour intake, heart rate, oxygen level Daily messages requesting weight, intake, pulse ox and pulse are automated Virtual home visits occur twice weekly where the investigators see the infant and families.
Behavioral: Daily Messages, Virtual Home Visits
Infants will have usual care as defined by cardiology.
Other: Usual Care
Intervention includes: Measuring daily weights, 24 hour intake, heart rate, oxygen level Daily messages requesting weight, intake, pulse ox and pulse are automated Virtual home visits occur twice weekly where the investigators see the infant and families.
Usual care as defined by by the Cardiology Department.
Parental Stress Score
Parental Stress will be measured through the use of the total score of Parental Stress Index collected at the completion of the study period for the infant and family, approximately 5 months of infant's life.
Time frame: Within 5 months of infant's life
Parental Quality of life Score
Parental Quality of life will be measured by total score of "QOL, The Ulm Quality of Life Inventory for Parents (ULQIE)" collected at the completion of the study period for the infant and family, approximately 5 months of infant's life.
Time frame: Within 5 months of infant's life
Parental Social Isolation Score
Parental social isolation will be measured by the total score on the Enriched SocialSupport Index with higher scores indicating more support which is collected within 5 months of the infant's life.
Time frame: Within 5 months of Infant's life.
Weight Gain at 5 months.
Weight gain will be measured by change in z scores of infant's weight (measured in grams)which will be obtained at discharge from the hospital and at the end of the study period, approximately 5 months of life.
Time frame: Within 5 months of life
Post Traumatic Stress Disorder Symptoms
Post Traumatic Stress Disorder Symptoms will be measured by the number of symptoms on the Post Traumatic Stress Disorder Scale at the end of the study period, within 5 months of the infant's life.
Time frame: Within 5 month's of Infant's Life
Health Care Resource Utilization
Health Care Utilization will be measured by per patient costs based on number of re-hospitalizations, Length of Stay of re-hospitalization, number of emergency department visits and number of acute care visits within 5 months of infant's life.
Time frame: Within 5 month's of infants life.
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Children's Hospital of Philadelphia