Tele-Clinic Visits in Pediatric Marfan Patients Using Parental Echo: The Future?

Stanford University

Status: Completed

Conditions: Marfan Syndrome

Treatments: Other: Tele-Clinic Visits Using Parent-Acquired Echos

Study type: Interventional

Funder types: Other

Identifiers

NCT03581682

42159

Details and patient eligibility

About

Marfan syndrome (MFS), a connective tissue disorder seen in 1 in 3,000 individuals, causes progressive aortic root dilation that can result in aortic dissection and sudden death. Clinical care focuses on monitoring the aortic root by serial echocardiography (echo) to guide medical treatment and elective aortic root surgery in a specialized clinic every 6-12 months. This monitoring protocol, coupled with surgical intervention, has doubled the median life expectancy which was previously only 32 years. However, this surveillance carries significant health care costs at >$50 million dollars/year on echos alone (at $3-4K each) in children and adolescents in the US, as well as substantial burden on families residing far from specialized centers. A clinic visit delivered to MFS patients via live-video conferencing at home (tele-visit) could shift this paradigm, if a home echo could be obtained.

Here, the investigator will train parents of Pediatric Marfan patients to take echo images using a hand held device, height, weight, blood pressure, medical history, and listen to the heart of their child. Then, the investigators will ask them to take the equipment home and collect the same data at home during a tele-clinic visit, with further instruction by the study team through secure live-video conferencing.

Full description

In the proposed intervention, every patient (n=60) will have a tele-visit and an on-site clinic visit 1 day apart. Parents will have a 1-hour hands-on training session to acquire basic echo images on their children with the same hand-held device that will be used during the tele-visit. Tele-visit elements will include interim medical history by the parent and patient, and weight, height, vital signs, digital cardiac auscultation, and home echo (transferred via Internet for remote interpretation), all obtained by the parent. Two MFS physicians, following our routine MFS care protocol, will administer either the tele-visit or on-site clinic visit, masked to the findings of the other. Two independent echo readers will analyze home and clinic echos to measure reproducibility.

Enrollment: 15 patients

Sex: All

Ages: 5 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 5-19 years of age (patient)
• seen in at least 2 prior clinic visits
• Marfan syndrome by revised Ghent criteria
• presence of parent at home

Exclusion criteria

• prior aortic surgery
• known cardiomyopathy
• known arrhythmia
• aortic root > 4.5 cm in prior clinic visit
• pregnancy

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Tele-Visit Using Parental Home Echo

Experimental group

Description:

All parents will have hands-on echo training. We will test if a tele-visit using parental home echo is clinically reliable compared to an on-site clinic visit, costs less, and improves parental sense of empowerment.

Treatment:

Other: Tele-Clinic Visits Using Parent-Acquired Echos