Transitional Telehealth Home Care: REACH

Not Applicable

Completed

• Conditions: Congenital Heart Disease; Post Cardiac Surgery
• Interventions: Other: Usual Care; Behavioral: Daily Messages, Virtual Home Visits

• Registration Number: NCT01941667
• Lead Sponsor: Children's Hospital of Philadelphia

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2013-02-28
• Study First Submitted QC: 2013-09-12
• Study First Posted: 2013-09-13
• Primary Completion: 2016-11
• Study Completion: 2017-07
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-29
• Last Update Posted: 2017-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	Infants will have usual care as defined by cardiology.
Daily Messages, virtual home visits	Daily 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Children's Hospital of PHiladelphia; 🇺🇸 Philadelphia, Pennsylvania, United States