Transitional Telehealth Home Care: REACH
Primary Purpose
Congenital Heart Disease, Post Cardiac Surgery
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Daily Messages, Virtual Home Visits
Usual Care
Sponsored by
About this trial
This is an interventional supportive care trial for Congenital Heart Disease focused on measuring Congenital Heart Disease, Neonates and infants, Telehealth, Virtual Home Visits
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
Sites / Locations
- Cincinnati Children's Hospital Medical Center
- Children's Hospital of PHiladelphia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Daily Messages, virtual home visits
Usual Care
Arm Description
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.
Infants will have usual care as defined by cardiology.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT01941667
First Posted
February 28, 2013
Last Updated
September 29, 2017
Sponsor
Children's Hospital of Philadelphia
Collaborators
Children's Hospital Medical Center, Cincinnati, National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT01941667
Brief Title
Transitional Telehealth Home Care: REACH
Official Title
Transitional Telehealth Home Care: REACH
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
Children's Hospital Medical Center, Cincinnati, National Institutes of Health (NIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease, Post Cardiac Surgery
Keywords
Congenital Heart Disease, Neonates and infants, Telehealth, Virtual Home Visits
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
218 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Daily Messages, virtual home visits
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Placebo Comparator
Arm Description
Infants will have usual care as defined by cardiology.
Intervention Type
Behavioral
Intervention Name(s)
Daily Messages, Virtual Home Visits
Intervention Description
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 Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Usual care as defined by by the Cardiology Department.
Primary Outcome Measure Information:
Title
Parental Stress Score
Description
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.
Time Frame
Within 5 months of infant's life
Secondary Outcome Measure Information:
Title
Parental Quality of life Score
Description
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.
Time Frame
Within 5 months of infant's life
Title
Parental Social Isolation Score
Description
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.
Time Frame
Within 5 months of Infant's life.
Title
Weight Gain at 5 months.
Description
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.
Time Frame
Within 5 months of life
Title
Post Traumatic Stress Disorder Symptoms
Description
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.
Time Frame
Within 5 month's of Infant's Life
Other Pre-specified Outcome Measures:
Title
Health Care Resource Utilization
Description
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.
Time Frame
Within 5 month's of infants life.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Weeks
Maximum Age & Unit of Time
5 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Medoff-Cooper, PhD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Children's Hospital of PHiladelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34839196
Citation
Golfenshtein N, Lisanti AJ, Cui N, Cooper BM. Predictors of Post-traumatic stress symptomology in parents of infants with Congenital Heart Disease post-surgery and after four months. J Pediatr Nurs. 2022 Jan-Feb;62:17-22. doi: 10.1016/j.pedn.2021.11.013. Epub 2021 Nov 25.
Results Reference
derived
PubMed Identifier
32817266
Citation
Medoff Cooper B, Marino BS, Fleck DA, Lisanti AJ, Golfenshtein N, Ravishankar C, Costello JM, Huang L, Hanlon AL, Curley MAQ. Telehealth Home Monitoring and Postcardiac Surgery for Congenital Heart Disease. Pediatrics. 2020 Sep;146(3):e20200531. doi: 10.1542/peds.2020-0531.
Results Reference
derived
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Transitional Telehealth Home Care: REACH
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