Congenital Heart Disease, Post Cardiac Surgery
Conditions
Keywords
Congenital Heart Disease, Neonates and infants, Telehealth, Virtual Home Visits
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALDaily Messages, Virtual Home Visits
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.
OTHERUsual Care
Usual care as defined by by the Cardiology Department.
Sponsors
Children's Hospital Medical Center, Cincinnati
National Institutes of Health (NIH)
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Weeks to 5 Months
Healthy volunteers
No
Inclusion criteria
* Cardiac surgery within 2.5 weeks of life, * Diagnosis of congenital heart disease, * Post menstrual age 37 weeks and older; * Minimum birth weight 2500 grams, * At least one parent speaks and reads English, * Anticipated discharge by 21 days of life
Exclusion criteria
* Cardiomyopathy, * Diagnosis of Genetic syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parental Stress Score | Within 5 months of infant's life | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parental Quality of life Score | Within 5 months of infant's life | 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. |
| Parental Social Isolation Score | Within 5 months of Infant's life. | 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. |
| Weight Gain at 5 months. | Within 5 months of life | 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. |
| Post Traumatic Stress Disorder Symptoms | Within 5 month's of Infant's Life | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health Care Resource Utilization | Within 5 month's of infants life. | 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. |
Countries
United States
Outcome results
None listed