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OpenTrials
Completed

NCT Number: NCT02490566

Enhanced Primary Care and Technology for Children With Chronic Disease

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.

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Key information

Conditions

Overweight Asthma Behavior Body Weight Bronchial Diseases Chronic Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases Signs and Symptoms

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Borinquen Health Care Center

Miami, Florida, 33161, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telehealth

Other

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 outcomes

  1. Number of participants compliant with supportive care visits

    Time frame: month 6

    Measure supportive care visits attended by participants

Secondary outcomes

  1. Effect of telehealth on participants knowledge of their chronic condition

    Time frame: month 6

    Change in knowledge surveys given pre- and post-intervention.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Verizon Wireless

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 7, 2015
Registry last updated
Jul 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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