Enhanced Primary Care and Technology for Children With Chronic Disease

Sponsor

University of Miami (Other)

Overall Status

Completed

CT.gov ID

NCT02490566

Collaborator

Verizon Wireless (Industry)

Enrollment

Location

Arm

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Overweight Obesity Asthma	Other: Telehealth	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Technology Arm Tablet computer with chronic disease apps will be given to patients. This tablet will also be used for follow-up visits done via video conferencing. Intervention: Telehealth.	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.

Arm

Intervention/Treatment

Experimental: Technology Arm

Tablet computer with chronic disease apps will be given to patients. This tablet will also be used for follow-up visits done via video conferencing. Intervention: Telehealth.

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.

Outcome Measures

Primary Outcome Measures

Number of participants compliant with supportive care visits [month 6]
Measure supportive care visits attended by participants

Secondary Outcome Measures

Effect of telehealth on participants knowledge of their chronic condition [month 6]
Change in knowledge surveys given pre- and post-intervention.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

None.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Borinquen Health Care Center	Miami	Florida	United States	33161

Sponsors and Collaborators

University of Miami
Verizon Wireless

Investigators

Principal Investigator: Judy Schaechter, M.D., M.B.A., University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Judy Schaechter, M.D., M.B.A., Chair of the Department of Pediatrics, University of Miami

ClinicalTrials.gov Identifier:

NCT02490566

Other Study ID Numbers:

20140732

First Posted:

Jul 7, 2015

Last Update Posted:

Jul 26, 2016

Last Verified:

Jul 1, 2016

Keywords provided by Judy Schaechter, M.D., M.B.A., Chair of the Department of Pediatrics, University of Miami

Additional relevant MeSH terms:

Overweight

Study Results

No Results Posted as of Jul 26, 2016