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Summary

for people ages 5–17 (full criteria)
healthy people welcome
study started
estimated completion:
Edward S Cruz

Description

Summary

To conduct a pilot test to estimate the effect of a novel reminder system in improving daily asthma controller medication adherence rates in children with monolingual Spanish-speaking guardians who have limited English Proficiency (LEP).

Official Title

Interventions to Help Asthma Clinical Adherence

Details

The primary hypothesis is to conduct a pilot test to estimate the effect of the SmartInhaler device in improving daily asthma controller medication adherence rates in children with monolingual Spanish- speaking guardians who have LEP during a six-week intervention period when compared to baseline medication adherence rates in a preceding six-week run-in period. The secondary hypothesis is to determine whether the patient reminder system can improve asthma symptom control during the same six-week intervention period. The third hypothesis is to assess if there are specific, patient behavior characteristics which are associated with the success of a novel asthma medication reminder system.

Keywords

Asthma/Drug Therapy Medication Adherence/Statistics & Numerical Data Reminder Systems Humans Hispanic Americans Communication Barriers Child

Eligibility

You can join if…

Open to people ages 5–17

    1. We will recruit 30 children ages 5 to 17 years with a diagnosis of persistent asthma who require a daily inhaled corticosteroid metered dose inhaler and whose guardian is the person responsible for administering their daily asthma medication.
    2. We wil recruit only patients who have received or receive care at San Francisco General Hospital's 6M Children's Health Center.
    3. We will recruit patients whose daily inhaled corticosteroid are metered dose inhalers (MDI) of either Flovent (fluticasone propionate) HFA (Hydrofluoroalkane) or Qvar (beclamethasone dipropionate) HFA.
    4. We will also recruit only patients whose guardian responsible for administering their daily asthma medication has Limited English Proficiency (LEP) and whose primary language is Spanish.

You CAN'T join if...

    1. We will exclude patients whose guardian responsible for administering their daily asthma medication does not have a Bluetooth enabled cell phone capable of receiving text messages.
    2. We will exclude patients whose guardian responsible for administering their daily asthma medication does not have an available reliable power outlet where they can recharge the battery of their SmartInhaler.
    3. We will exclude patients whose guardian responsible for administering their daily asthma edication is unable to demonstrate correct medication technique based on standard evaluation (Press, 2011) after completion of a standard teaching protocol.
    4. We will exclude patients with chronic lung disease. 6. We will exclude patients who do not have an operating system of iOS or Android on their cell phone and who have no data plan with their cellular phone plan.
    5. We will exclude patients whose asthma medication regimen is being managed by an asthma subspecialist or health provider outside of the 6M Children's Health Center at San Francisco General Hospital.
    6. We will exclude patients who are using an inhaled long acting beta-agonist (LABA)as part of their asthma management plan.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02999789
Phase
Phase 4
Lead Scientist
Edward S Cruz
Study Type
Interventional
Last Updated
December 1, 2016
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