Clinical trial NCT01941667: Transitional Telehealth Home Care: REACH
Official title: Transitional Telehealth Home Care: REACH
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Post Cardiac Surgery
Keywords: Congenital Heart Disease
Neonates and infants
Telehealth
Virtual Home Visits
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Children's Hospital Medical Center, Cincinnati
name: National Institutes of Health (NIH)
First posted: 2013-09-13
Enrollment: 218
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Parental Stress Score
timeFrame: Within 5 months of infant's life
Secondary outcomes:
measure: Parental Quality of life Score
timeFrame: Within 5 months of infant's life
measure: Parental Social Isolation Score
timeFrame: Within 5 months of Infant's life.
measure: Weight Gain at 5 months.
timeFrame: Within 5 months of life
measure: Post Traumatic Stress Disorder Symptoms
timeFrame: Within 5 month's of Infant's Life
Other outcomes:
measure: Health Care Resource Utilization
timeFrame: Within 5 month's of infants life.
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of PHiladelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Barbara Medoff-Cooper, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.