Back to resultsInterventions To Help Asthma Clinical Adherence (ITHACA)
Primary Purpose
Asthma in Children, Humans, Hispanic Americans
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SmartInhaler with reminder function turned on
SmartInhaler
Sponsored by
About this trial
This is an interventional health services research trial for Asthma in Children focused on measuring Asthma/drug therapy, Medication Adherence/statistics & numerical data, Reminder Systems, Communication Barriers
Eligibility Criteria
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.
Sites / Locations
- Zuckerberg San Francisco General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intervention: Reminder System
Placebo: Delayed Reminder System
Arm Description
After an initial six week run-in period, participants will be randomized to either the intervention group or placebo group. The intervention group will have SMS reminder and audiovisual reminder functions turned on. SMS reminders will be sent twice daily to child's caregiver's cell phone reminding them to administer daily asthma medication. SmartInhaler with reminder function turned on that is attached to Inhaler medication will remind child's caregiver twice daily to administer daily asthma medication.
After an initial six week run-in period, participants will be randomized to either the intervention group or placebo group. The placebo group will have SMS reminder and audiovisual reminder functions turned off. The SmartInhaler will only function to measure daily adherence. Once intervention group has finished their 6 week period, this group will have intervention turned on.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02999789
First Posted
December 16, 2016
Last Updated
March 23, 2023
Sponsor
University of California, San Francisco
Collaborators
Academic Pediatric Association
1. Study Identification
Unique Protocol Identification Number
NCT02999789
Brief Title
Interventions To Help Asthma Clinical Adherence
Acronym
ITHACA
Official Title
Interventions to Help Asthma Clinical Adherence
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 2017 (undefined)
Primary Completion Date
November 2019 (Actual)
Study Completion Date
November 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Academic Pediatric Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children, Humans, Hispanic Americans, Child
Keywords
Asthma/drug therapy, Medication Adherence/statistics & numerical data, Reminder Systems, Communication Barriers
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention: Reminder System
Arm Type
Active Comparator
Arm Description
After an initial six week run-in period, participants will be randomized to either the intervention group or placebo group. The intervention group will have SMS reminder and audiovisual reminder functions turned on. SMS reminders will be sent twice daily to child's caregiver's cell phone reminding them to administer daily asthma medication. SmartInhaler with reminder function turned on that is attached to Inhaler medication will remind child's caregiver twice daily to administer daily asthma medication.
Arm Title
Placebo: Delayed Reminder System
Arm Type
Placebo Comparator
Arm Description
After an initial six week run-in period, participants will be randomized to either the intervention group or placebo group. The placebo group will have SMS reminder and audiovisual reminder functions turned off. The SmartInhaler will only function to measure daily adherence. Once intervention group has finished their 6 week period, this group will have intervention turned on.
Intervention Type
Device
Intervention Name(s)
SmartInhaler with reminder function turned on
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
SmartInhaler
Intervention Description
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 Outcome Measure Information:
Title
Change in Percentage of Doses Received
Description
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.
Time Frame
Baseline and 6 weeks post intervention
Secondary Outcome Measure Information:
Title
Asthma Symptom Control Score Change
Description
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.
Time Frame
Baseline and 6 weeks post intervention
Other Pre-specified Outcome Measures:
Title
Type of Non-adherence
Description
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)
Time Frame
Six weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward S Cruz, MD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zuckerberg San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Interventions To Help Asthma Clinical Adherence
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