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| Name | Class |
|---|---|
| Children's Hospital Medical Center, Cincinnati | OTHER |
| National Institutes of Health (NIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily Messages, virtual home visits | Experimental | 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 | Placebo Comparator | Infants will have usual care as defined by cardiology. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daily Messages, Virtual Home Visits | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 5 months of infant's life |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 5 months of infant's life |
| Parental Social Isolation Score |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 5 month's of infants life. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Medoff-Cooper, PhD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States | ||
| Children's Hospital of PHiladelphia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36696826 | Derived | Lisanti AJ, Golfenshtein N, Min J, Medoff-Cooper B. Early growth trajectory is associated with psychological stress in parents of infants with congenital heart disease, but moderated by quality of partner relationship. J Pediatr Nurs. 2023 Mar-Apr;69:93-100. doi: 10.1016/j.pedn.2022.12.016. Epub 2023 Jan 23. | |
| 34839196 | Derived |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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|
| Usual Care | Other | Usual care as defined by by the Cardiology Department. |
|
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. |
| 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. | 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. | Within 5 month's of Infant's Life |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Golfenshtein N, Lisanti AJ, Cui N, Cooper BM. Predictors of Post-traumatic stress symptomology in parents of infants with Congenital Heart Disease post-surgery and after four months. J Pediatr Nurs. 2022 Jan-Feb;62:17-22. doi: 10.1016/j.pedn.2021.11.013. Epub 2021 Nov 25. |
| 32817266 | Derived | Medoff Cooper B, Marino BS, Fleck DA, Lisanti AJ, Golfenshtein N, Ravishankar C, Costello JM, Huang L, Hanlon AL, Curley MAQ. Telehealth Home Monitoring and Postcardiac Surgery for Congenital Heart Disease. Pediatrics. 2020 Sep;146(3):e20200531. doi: 10.1542/peds.2020-0531. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |