Enhanced Primary Care and Technology for Children With Chronic Disease
Primary Purpose
Overweight, Obesity, Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telehealth
Sponsored by
About this trial
This is an interventional supportive care trial for Overweight focused on measuring chronic condition, telehealth, nutrition, exercise
Eligibility Criteria
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.
Sites / Locations
- Borinquen Health Care Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Technology Arm
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of participants compliant with supportive care visits
Measure supportive care visits attended by participants
Secondary Outcome Measures
Effect of telehealth on participants knowledge of their chronic condition
Change in knowledge surveys given pre- and post-intervention.
Full Information
NCT ID
NCT02490566
First Posted
June 29, 2015
Last Updated
July 23, 2016
Sponsor
University of Miami
Collaborators
Verizon Wireless
1. Study Identification
Unique Protocol Identification Number
NCT02490566
Brief Title
Enhanced Primary Care and Technology for Children With Chronic Disease
Official Title
Piloting Enhanced Pediatric Care for Children With Chronic Condition/Technology Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Verizon Wireless
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity, Asthma
Keywords
chronic condition, telehealth, nutrition, exercise
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Technology Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Telehealth
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants compliant with supportive care visits
Description
Measure supportive care visits attended by participants
Time Frame
month 6
Secondary Outcome Measure Information:
Title
Effect of telehealth on participants knowledge of their chronic condition
Description
Change in knowledge surveys given pre- and post-intervention.
Time Frame
month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judy Schaechter, M.D., M.B.A.
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Borinquen Health Care Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
12. IPD Sharing Statement
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Enhanced Primary Care and Technology for Children With Chronic Disease
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