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Transitional Telehealth Home Care: REACH

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01941667
First Posted: September 13, 2013
Last Update Posted: October 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Children's Hospital Medical Center, Cincinnati
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
  Purpose
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.

Condition Intervention
Congenital Heart Disease Post Cardiac Surgery Behavioral: Daily Messages, Virtual Home Visits Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Transitional Telehealth Home Care: REACH

Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Parental Quality of life Score [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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.


Other Outcome Measures:
  • Health Care Resource Utilization [ Time Frame: Within 5 month's of infants life. ]
    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.


Enrollment: 218
Study Start Date: July 2012
Study Completion Date: July 2017
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

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.

Placebo Comparator: Usual Care
Infants will have usual care as defined by cardiology.
Other: Usual Care
Usual care as defined by by the Cardiology Department.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 5 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941667


Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Children's Hospital of PHiladelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Children's Hospital Medical Center, Cincinnati
National Institutes of Health (NIH)
Investigators
Principal Investigator: Barbara Medoff-Cooper, PhD Children's Hospital of Philadelphia
  More Information

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01941667     History of Changes
Other Study ID Numbers: 11-008246
First Submitted: February 28, 2013
First Posted: September 13, 2013
Last Update Posted: October 3, 2017
Last Verified: September 2017

Keywords provided by Children's Hospital of Philadelphia:
Congenital Heart Disease
Neonates and infants
Telehealth
Virtual Home Visits

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities