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Interventions To Help Asthma Clinical Adherence (ITHACA)

This study is not yet open for participant recruitment.
Verified December 2016 by Edward Cruz, University of California, San Francisco
Sponsor:
ClinicalTrials.gov Identifier:
NCT02999789
First Posted: December 21, 2016
Last Update Posted: December 21, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Academic Pediatric Association
Information provided by (Responsible Party):
Edward Cruz, University of California, San Francisco
  Purpose
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 Intervention Phase
Asthma/Drug Therapy Medication Adherence/Statistics & Numerical Data Reminder Systems Humans Hispanic Americans Communication Barriers Child Device: SmartInhaler with reminder function turned on Device: SmartInhaler Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Interventions to Help Asthma Clinical Adherence

Resource links provided by NLM:


Further study details as provided by Edward Cruz, University of California, San Francisco:

Primary Outcome Measures:
  • 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:
  • 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:
  • 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)


Estimated Enrollment: 30
Study Start Date: January 2017
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 reminding 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.

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.
  Eligibility

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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. We will recruit 30 children 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. We wil recruit only patients who have received or receive care at San Francisco General Hospital's 6M Children's Health Center.

    3. We will recruit patients whose daily inhaled corticosteroid are metered dose inhalers (MDI) of either Flovent (fluticasone propionate) HFA (Hydrofluoroalkane) or Qvar (beclamethasone dipropionate) HFA.

    4. We will also recruit only patients whose guardian responsible for administering their daily asthma medication has Limited English Proficiency (LEP) and whose primary language is Spanish.

Exclusion Criteria:

  • 1. We will exclude patients whose guardian responsible for administering their daily asthma medication does not have a Bluetooth enabled cell phone capable of receiving text messages.

    2. We will exclude patients 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. We will exclude patients whose guardian responsible for administering their daily asthma edication is unable to demonstrate correct medication technique based on standard evaluation (Press, 2011) after completion of a standard teaching protocol.

    5. We will exclude patients with chronic lung disease. 6. We will exclude patients 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.

    7. We will exclude patients 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.

    8. We will exclude patients who are using an inhaled long acting beta-agonist (LABA) as part of their asthma management plan.

  Contacts and Locations
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

Sponsors and Collaborators
University of California, San Francisco
Academic Pediatric Association
Investigators
Principal Investigator: Edward S Cruz, MD, MPH University of California, San Francisco
  More Information

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 Submitted: December 16, 2016
First Posted: December 21, 2016
Last Update Posted: December 21, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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