Transitional Telehealth Home Care: REACH
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 218
- Locations
- 2
- Primary Endpoint
- Parental Stress Score
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 2 Weeks to 5 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Daily Messages, Virtual Home Visits (Behavioral)
Usual Care
Infants will have usual care as defined by cardiology.
Intervention: Usual Care (Other)
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)