NCT02490566

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 26, 2016

Status Verified

July 1, 2016

Enrollment Period

11 months

First QC Date

June 29, 2015

Last Update Submit

July 23, 2016

Conditions

Keywords

chronic conditiontelehealthnutritionexercise

Outcome Measures

Primary Outcomes (1)

  • Number of participants compliant with supportive care visits

    Measure supportive care visits attended by participants

    month 6

Secondary Outcomes (1)

  • Effect of telehealth on participants knowledge of their chronic condition

    month 6

Study Arms (1)

Technology Arm

EXPERIMENTAL

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

Interventions

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.

Technology Arm

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Borinquen Health Care Center

Miami, Florida, 33161, United States

Location

MeSH Terms

Conditions

OverweightObesityAsthmaChronic DiseaseMotor Activity

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesDisease AttributesPathologic ProcessesBehavior

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Judy Schaechter, M.D., M.B.A.

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of the Department of Pediatrics

Study Record Dates

First Submitted

June 29, 2015

First Posted

July 7, 2015

Study Start

July 1, 2015

Primary Completion

June 1, 2016

Study Completion

July 1, 2016

Last Updated

July 26, 2016

Record last verified: 2016-07

Locations