Interventions To Help Asthma Clinical Adherence (ITHACA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02999789|
Recruitment Status : Completed
First Posted : December 21, 2016
Last Update Posted : April 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Asthma in Children Humans Hispanic Americans Child||Device: SmartInhaler with reminder function turned on Device: SmartInhaler||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Interventions to Help Asthma Clinical Adherence|
|Study Start Date :||January 2017|
|Actual Primary Completion Date :||November 2019|
|Actual Study Completion Date :||November 2019|
Active Comparator: Intervention group
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.
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.
Placebo Comparator: Placebo
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.
The SmartInhaler is a medication monitoring system manufactored by Adherium that also functions as a patient reminder device. It monitors asthma medication adherence and also functions by providing an audiovisual reminder.
- Adherence rate [ Time Frame: Six weeks ]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 during a six-week intervention period when compared to baseline medication adherence rates in a preceding six-week run-in period.
- Asthma symptom control [ Time Frame: Six weeks ]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.
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02999789
|United States, California|
|Zuckerberg San Francisco General Hospital|
|San Francisco, California, United States, 94110|
|Principal Investigator:||Edward S Cruz, MD, MPH||University of California, San Francisco|