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Interventions To Help Asthma Clinical Adherence (ITHACA)

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ClinicalTrials.gov Identifier: NCT02999789
Recruitment Status : Recruiting
First Posted : December 21, 2016
Last Update Posted : May 17, 2018
Sponsor:
Collaborator:
Academic Pediatric Association
Information provided by (Responsible Party):
Edward Cruz, University of California, San Francisco

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).

Condition or disease Intervention/treatment Phase
Asthma in Children Humans Hispanic Americans Child Device: SmartInhaler with reminder function turned on Device: SmartInhaler Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
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
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
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.
Device: SmartInhaler
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  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)



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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: Edward S Cruz, MD, MPH 415-206-2837 edward.cruz@ucsf.edu

Locations
United States, California
Zuckerberg San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
Contact: Edward S Cruz, MD, MPH    415-206-2837    edward.cruz@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Academic Pediatric Association
Investigators
Principal Investigator: Edward S Cruz, MD, MPH University of California, San Francisco

Responsible Party: Edward Cruz, Edward Cruz, MD, MPH, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02999789     History of Changes
Other Study ID Numbers: 15-16445
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Edward Cruz, University of California, San Francisco:
Asthma/drug therapy
Medication Adherence/statistics & numerical data
Reminder Systems
Communication Barriers

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases