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Completed

NCT Number: NCT01941667

Transitional Telehealth Home Care: REACH

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.

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Key information

Age range

2 week–5 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Daily Messages, Virtual Home Visits

Behavioral

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.

Usual Care

Other

Usual care as defined by by the Cardiology Department.

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Children's Hospital Medical Center, Cincinnati
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Sep 13, 2013
Registry last updated
Oct 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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