Transitional Telehealth Home Care: REACH

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Transitional Telehealth Home Care: REACH

Conditions
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Congenital Heart Disease, Post Cardiac Surgery

Intervention / Treatment
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* Behavioral: Daily Messages, Virtual Home Visits
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Weeks
Maximum Age: 5 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daily Messages, virtual home visits<br>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<br>* 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.<br>|
| Placebo Comparator: Usual Care<br>Infants will have usual care as defined by cardiology. | Other: Usual Care<br>* Usual care as defined by by the Cardiology Department.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congenital Heart Disease, Neonates and infants, Telehealth, Virtual Home Visits