- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02490566
Enhanced Primary Care and Technology for Children With Chronic Disease
Piloting Enhanced Pediatric Care for Children With Chronic Condition/Technology Trial
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Florida
-
Miami, Florida, Förenta staterna, 33161
- Borinquen Health Care Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of participants compliant with supportive care visits
Tidsram: month 6
|
Measure supportive care visits attended by participants
|
month 6
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Effect of telehealth on participants knowledge of their chronic condition
Tidsram: month 6
|
Change in knowledge surveys given pre- and post-intervention.
|
month 6
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Judy Schaechter, M.D., M.B.A., University of Miami
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 20140732
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