Interventions To Help Asthma Clinical Adherence

Asthma in Children Clinical Trial

— ITHACA  

Official title:

Interventions to Help Asthma Clinical Adherence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02999789
• Other study ID #: 15-16445
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: November 2019

Study information

• Verified date: March 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

Inclusion Criteria:

1. 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.

2. The investigators will recruit only participants who have received or receive care at San Francisco General Hospital's 6M Children's Health Center.

3. 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.

4. 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:

1. 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.

2. 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.

3. 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.

4. The Investigators will exclude participants with chronic lung disease.

5. 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.

6. 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.

7. The Investigators will exclude participants who are using an inhaled long acting beta-agonist (LABA) as part of their asthma management plan.

Related Conditions & MeSH terms

• Asthma
• Asthma in Children
• Child
• Hispanic Americans
• Humans

Intervention

Device:
• SmartInhaler with reminder function turned on
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
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.

Locations

Country	Name	City	State
United States	Zuckerberg San Francisco General Hospital	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Academic Pediatric Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Type of Non-adherence	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)	Six weeks
Primary	Change in Percentage of Doses Received	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.	Baseline and 6 weeks post intervention
Secondary	Asthma Symptom Control Score Change	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.	Baseline and 6 weeks post intervention