Asthma in Children, Child, Hispanic Americans, Humans
Conditions
Keywords
Asthma/drug therapy, Medication Adherence/statistics & numerical data, Reminder Systems, Communication Barriers
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.
Interventions
DEVICESmartInhaler 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.
DEVICESmartInhaler
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.
Sponsors
Academic Pediatric Association
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Percentage of Doses Received | 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
| Measure | Time frame | Description |
|---|---|---|
| Asthma Symptom Control Score Change | 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
| Measure | Time frame | Description |
|---|---|---|
| Type of Non-adherence | 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) |
Countries
United States
Participant flow
Pre-assignment details
13 participants were enrolled in total, 6 participants dropped out pre-randomization, and 4 participants were randomized to the intervention (reminder system) arm and 3 participants were randomized to the placebo (delayed reminder system) arm.
Participants by arm
| Arm | Count |
|---|---|
| Reminder System Arm Participants 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.
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. | 4 |
| Delayed Reminder System Arm Participants 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.
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. | 3 |
| Enrolled But Not Randomized Participants were enrolled but not randomized. | 6 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Became ineligible | 1 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Reminder System Arm Participants | Delayed Reminder System Arm Participants | Enrolled But Not Randomized | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 4 Participants | 3 Participants | 6 Participants | 13 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 3 Participants | 6 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 4 Participants | 3 Participants | 6 Participants | 13 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 2 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 4 | 0 / 3 |
| other Total, other adverse events | 0 / 13 | 0 / 4 | 0 / 3 |
| serious Total, serious adverse events | 0 / 13 | 0 / 4 | 0 / 3 |
Outcome results
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.
Time frame: Baseline and 6 weeks post intervention
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention: Reminder System | Change in Percentage of Doses Received | 22.0 Percentage of doses received |
| Placebo: Delayed Reminder System | Change in Percentage of Doses Received | 12.4 Percentage of doses received |
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.
Time frame: Baseline and 6 weeks post intervention
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention: Reminder System | Asthma Symptom Control Score Change | 3.0 Score on a scale |
| Placebo: Delayed Reminder System | Asthma Symptom Control Score Change | 0 Score on a scale |
Other Pre-specified
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)
Time frame: Six weeks