Transitional Telehealth Home Care: REACH

Congenital Heart Disease Clinical Trial

Official title:

Transitional Telehealth Home Care: REACH

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01941667
• Other study ID #: 11-008246
• Status: Completed
• Phase: N/A
• First received: February 28, 2013
• Last updated: September 29, 2017
• Start date: July 2012
• Est. completion date: July 2017

Study information

• Verified date: September 2017
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: July 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Months

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Post Cardiac Surgery

Intervention

Behavioral:
• 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.

Other:
• Usual Care
Usual care as defined by by the Cardiology Department.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Children's Hospital of PHiladelphia	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Children's Hospital Medical Center, Cincinnati, National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health Care Resource Utilization	Health Care Utilization will be measured by per patient costs based on number of re-hospitalizations, Length of Stay of re-hospitalization, number of emergency department visits and number of acute care visits within 5 months of infant's life.	Within 5 month's of infants life.
Primary	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	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
Secondary	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.
Secondary	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
Secondary	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