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OpenTrials
Completed

NCT Number: NCT02999789

Interventions To Help Asthma Clinical Adherence

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).

Completed

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Key information

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The investigators will recruit 30 participants 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.
  • The investigators will recruit only participants who have received or receive care at San Francisco General Hospital's 6M Children's Health Center.
  • The investigators will recruit participants whose daily inhaled corticosteroid are metered dose inhalers (MDI) of either Flovent (fluticasone propionate) HFA (Hydrofluoroalkane) or Qvar (beclamethasone dipropionate) HFA.
  • The Investigators will recruit only participants whose guardian responsible for administering their daily asthma medication has Limited English Proficiency (LEP) and whose primary language is Spanish.

Exclusion criteria

  • The Investigators will exclude participants whose guardian responsible for administering their daily asthma medication does not have a Bluetooth enabled cell phone capable of receiving text messages.
  • The Investigators will exclude participants 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.
  • The Investigators will exclude participants whose guardian responsible for administering their daily asthma medication is unable to demonstrate correct medication technique based on standard evaluation (Press, 2011) after completion of a standard teaching protocol.
  • The Investigators will exclude participants with chronic lung disease.
  • The Investigators will exclude participants 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.
  • The Investigators will exclude participants 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.
  • The Investigators will exclude participants who are using an inhaled long acting beta-agonist (LABA) as part of their asthma management plan.

Treatment and study plan

SmartInhaler with reminder function turned on

Device

The SmartInhaler is a medication monitoring system that functions as a patient reminder device. It monitors asthma medication adherence and also functions by providing an audiovisual reminder.

SmartInhaler

Device

The SmartInhaler is a medication monitoring system manufactured by Adherium that also functions as a patient reminder device. It monitors asthma medication adherence and also functions by providing an audiovisual reminder.

Primary outcomes

  1. Change in Percentage of Doses Received

    Time frame: Baseline and 6 weeks post intervention

    Medication adherence for each medication was calculated as a percentage of the total number of doses received during the study period divided by the total number of doses prescribed. As a result, this percentage ranged from 0 to 100. Medication adherence percentages during both the run-in and intervention periods were measured and the differences between doses received between the two time periods was calculated for each patient.

Secondary outcomes

  1. Asthma Symptom Control Score Change

    Time frame: Baseline and 6 weeks post intervention

    The secondary hypothesis is to determine whether the patient reminder system can improve asthma symptom control during the same six-week intervention period. Asthma control will be measured by the Childhood asthma control test (C-ACT). The C-ACT is a 7 item scale, with scores ranging from 0 (poor asthma control) to 27 (complete asthma control). In general, a C-ACT score >19 indicates well-controlled asthma. Asthma symptom control scores during both the run-in and intervention periods were measured and the differences between scores between the two time periods was calculated for each patient.

Other outcomes

  1. Type of Non-adherence

    Time frame: Six weeks

    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. This will be assessed by the Reported Adherence to Medication survey (RAM)

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Academic Pediatric Association

Registry information

Acronym: ITHACA

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 21, 2016
Registry last updated
Apr 18, 2023

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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