Enhanced Primary Care and Technology for Children With Chronic Disease

Obesity Clinical Trial

Official title:

Piloting Enhanced Pediatric Care for Children With Chronic Condition/Technology Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02490566
• Other study ID #: 20140732
• Status: Completed
• Phase: N/A
• First received: June 29, 2015
• Last updated: July 23, 2016
• Start date: July 2015
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Using technology alongside a pediatric chronic disease specialist and behavior specialist, the investigators are planning to help care for and coordinate the healthcare of children with chronic diseases, particularly childhood obesity, diabetes and asthma in Miami's most vulnerable communities. The University of (UM) Miller School of Medicine (MSOM) Pediatrics and TeleHealth departments propose to leverage information and communications technologies (ICT) in an innovative approach to improve the quality, access and efficiency of pediatric services for children and their families.

Description:

Participants will be recruited from an outpatient clinic site with diagnoses of overweight, obesity or asthma.

There will be a total of 6 visits during the study at approximately 1 month intervals. During the first and last visits, pre- and post-intervention assessment points, quality of life, adherence to medical regimen, physical activity and dietary habits will be gathered. During the follow-up visits, only quality of life will be surveyed. At the initial visit, for overweight children, the patients will be assessed for their behaviors and attitudes regarding eating, physical activity, sedentary time and motivation. If the patient has asthma, the pediatrician will assess understanding of the disease.

Throughout the course of the study the chronic condition pediatrician and behavior specialist will see patients in a consult capacity for their chronic condition, but the patient will continue to see their regular pediatrician for primary care needs. At every visit the pediatrician will review changes since the last visit, and then provide education directed at overweight/obesity and/or asthma. The behavior health specialists will then work with the patients to develop a plan on how to follow their treatment plan and achieve healthy behaviors.

All of the participants will receive access to technology in the form of a tablet computer for the duration of the study. The tablets will be installed with software to help educate patients and their families about asthma and overweight/obesity and track progress in managing them. In addition, all follow-up visits except for the final one will be done using the tablets and a video-conferencing app.

For the first and last visits, all patients will be seen in-person in the clinic. All of the follow-up visits will be done via a video-conferencing app on the tablet computers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

Inclusion Criteria:

• Patients who receive care at the Borinquen Clinic

• Aged five through 18, inclusive

• Diagnosis of asthma (requiring medication) or overweight (greater than or equal to 85% for age).

• Fluent in English or Spanish.

• Parents/Guardians must be fluent in English or Spanish.

Exclusion Criteria:

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Asthma
• Obesity
• Overweight

Intervention

Other:
• Telehealth
Tablet with chronic disease apps will be given to this group, apps will be focused on patient's condition. Follow-up visits will be conducted through video-conferencing.

Locations

Country	Name	City	State
United States	Borinquen Health Care Center	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Verizon Wireless

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants compliant with supportive care visits	Measure supportive care visits attended by participants	month 6	No
Secondary	Effect of telehealth on participants knowledge of their chronic condition	Change in knowledge surveys given pre- and post-intervention.	month 6	No