Congenital Heart DiseaseNCT01941667
Transitional Telehealth Home Care: REACH
A study testing Daily Messages, Virtual Home Visits in people with Congenital Heart Disease and Post Cardiac Surgery, run by Children's Hospital of Philadelphia at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 2 weeks to 5 months
- Conditions the study is for
- Congenital Heart Disease, Post Cardiac Surgery
- What is being tested?
- Daily Messages, Virtual Home Visits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 218 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2012to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 weeks to 5 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Cardiomyopathy,
- Diagnosis of Genetic syndrome
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Children's Hospital of PHiladelphia
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the 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.
- Conditions
- Congenital Heart Disease, Post Cardiac Surgery
- Being tested
- Daily Messages, Virtual Home Visits, Usual Care
- Keywords
- Congenital Heart Disease, Neonates and infants, Telehealth, Virtual Home Visits
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily Messages, Virtual Home VisitsBehavioural
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 CareOther
Usual care as defined by by the Cardiology Department.
| Study group | Role | What they receive |
|---|---|---|
| Daily Messages, virtual home visits | Experimental | 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. Receives: Behavioral: Daily Messages, Virtual Home Visits |
| Usual Care | Placebo comparator | Infants will have usual care as defined by cardiology. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 5 months of infant's life
Secondary outcomes (4)
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.
Measured: Within 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.
Measured: Within 5 months of 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.
Measured: Within 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.
Measured: Within 5 month's of Infant's Life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startJul 2012
- Primary completionNov 2016
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati, National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Barbara Medoff-Cooper, PhD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941667
- Sponsor's protocol ID
- 11-008246
- Status last verified
- Sep 2017
- First submitted
- 28 Feb 2013
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lisanti AJ, Golfenshtein N, Min J, Medoff-Cooper B. Early growth trajectory is associated with psychological stress in parents of infants with congenital heart disease, but moderated by quality of partner relationship. J Pediatr Nurs. 2023 Mar-Apr;69:93-100. doi: 10.1016/j.pedn.2022.12.016. Epub 2023 Jan 23.
PubMed 36696826Golfenshtein 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.
PubMed 34839196Medoff 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.
PubMed 32817266
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transitional Telehealth Home Care: REACH
- ClinicalTrials.gov ID
- NCT01941667
- Acronym / sponsor ID
- 11-008246
- Conditions
- Congenital Heart Disease, Post Cardiac Surgery
- Keywords
- Congenital Heart Disease, Neonates and infants, Telehealth, Virtual Home Visits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati, National Institutes of Health (NIH)
- Study start
- Jul 2012
- Primary completion
- Nov 2016 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 13 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily Messages, virtual home visits | Experimental | Behavioral: Daily Messages, Virtual Home VisitsIntervention 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 | Placebo comparator | Other: Usual CareInfants will have usual care as defined by cardiology. |
Who may qualify
- Ages
- 2 weeks to 5 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (2 listed)
- Cardiomyopathy,
- Diagnosis of Genetic syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily Messages, Virtual Home VisitsIntervention 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. | Behavioural | Daily Messages, virtual home visits |
| Usual CareUsual care as defined by by the Cardiology Department. | Other | Usual Care |
Primary outcome
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.
4 secondary outcomes
Parental Quality of life Score
Time frame: Within 5 months of infant's life
Parental Social Isolation Score
Time frame: Within 5 months of Infant's life.
Weight Gain at 5 months.
Time frame: Within 5 months of life
Post Traumatic Stress Disorder Symptoms
Time frame: Within 5 month's of Infant's Life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
- Derived from this study: PubMed 36696826Lisanti AJ, Golfenshtein N, Min J, Medoff-Cooper B. Early growth trajectory is associated with psychological stress in parents of infants with congenital heart disease, but moderated by quality of partner relationship. J Pediatr Nurs. 2023 Mar-Apr;69:93-100. doi: 10.1016/j.pedn.2022.12.016. Epub 2023 Jan 23.
- Derived from this study: PubMed 34839196Golfenshtein 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.
- Derived from this study: PubMed 32817266Medoff 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Medoff-Cooper, PhD principal investigator
Children's Hospital of Philadelphia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily Messages, Virtual Home Visits in people with Congenital Heart Disease and Post Cardiac Surgery, run by Children's Hospital of Philadelphia at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Stress Score (time frame: Within 5 months of infant's life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01941667, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2017.