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Clinical Trials/NCT01941667
NCT01941667
Completed
N/A

Transitional Telehealth Home Care: REACH

Children's Hospital of Philadelphia2 sites in 1 country218 target enrollmentJuly 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Congenital Heart Disease
Sponsor
Children's Hospital of Philadelphia
Enrollment
218
Locations
2
Primary Endpoint
Parental Stress Score
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
July 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Parental Stress Score

Time Frame: 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 Outcomes

  • Parental Quality of life Score(Within 5 months of infant's life)
  • Parental Social Isolation Score(Within 5 months of Infant's life.)
  • Weight Gain at 5 months.(Within 5 months of life)
  • Post Traumatic Stress Disorder Symptoms(Within 5 month's of Infant's Life)

Study Sites (2)

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