Clinical trial NCT02176694: Adolescent Controlled Text Messaging to Improve Asthma Medication Adherence in Primary Care
Official title: Adolescent Controlled Text Messaging to Improve Asthma Medication Adherence in Primary Care.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Asthma
Keywords: persistent asthma
adherence
text message reminders
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-06-27
Enrollment: 29
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A randomized controlled trial of a texting intervention to increase adherence to preventative asthma medication in four Cincinnati Children's Hospital Medical Center primary care clinics.

Detailed description: Our first aim is to determine the feasibility, acceptability and use of a low intensity text messaging intervention to improve adherence to inhaled corticosteroid (ICS) therapy among high risk adolescents with persistent asthma. Our second aim is to determine effect sizes of the intervention to improve adherence (As measured by electronic monitoring and self-report); clinical asthma control; and asthma related quality of life among adolescents with persistent asthma. Our third and final aim is to determine the temporal relationship between text message receipt and ICS canister actuation in order to understand mechanisms by which text messaging may increase ICS adherence.

Eligibility criteria: Inclusion Criteria:

* provider-diagnosed persistent asthma
* prescription of an ICS in accordance in NHLBI Expert Panel Report 3 guidelines for at least 30 days prior to enrollment
* Asthma Control Test (ACT) score less than 20 (indicating lack of current control)
* no provider-diagnosed exacerbation in the 30 days prior to enrollment
* possession of a text-enabled cell phone and a plan to keep it throughout the study period
* agreement by parents (or participants over 18 years old) to any charges levied by their cell phone carrier for text messages associated with the study if they do not have an unlimited texting plan
* speak and read English

Exclusion Criteria:

* another chronic lung disease (which would complicate measurement of asthma control)
* cognitive or psychiatric disorder that the treating clinician judges would impair study participation
* use of Advair diskus for their ICS (for which no reliable electronic monitor exists)
* current enrollment in another asthma intervention study

Primary outcomes:
measure: Objective Adherence to ICS
timeFrame: Baseline
measure: Change in objective adherence to ICS
timeFrame: Change from baseline in objective adherence to ICS at 1 month
measure: Change in objective adherence to ICS
timeFrame: Continuous change over time from baseline in objective adherence to ICS at 2 months in intervention compared to control
measure: Change in objective adherence to ICS
timeFrame: Continuous change over time from baseline in objective adherence to ICS at 3 months in intervention compared to control
measure: Change in objective adherence to ICS
timeFrame: Continuous change over time from baseline in objective adherence to ICS at 4 months in intervention compared to control
measure: Change in objective adherence to ICS
timeFrame: Continuous change over time from baseline in objective adherence to ICS at 5 months in intervention compared to control
measure: Feasibility, Acceptability and Usability of the Text Messaging Website
timeFrame: At time of text messaging intervention
measure: Feasibility, Acceptability and Usability of the Text Messaging Website
timeFrame: up to 1 month after receiving text messages
measure: Feasibility, Acceptability and Usability of the Text Messaging Website
timeFrame: up to 2 months after receiving text messages
measure: Feasibility, Acceptability and Usability of the Text Messaging Website
timeFrame: up to 3 months after receiving text messages
Secondary outcomes:
measure: Asthma Control
timeFrame: Baseline
measure: Change in Asthma Control
timeFrame: Change from Baseline at 1 month
measure: Change in Asthma Control
timeFrame: Continuous change over time from baseline at 2 months in intervention compared to control
measure: Change in Asthma Control
timeFrame: Continuous change over time from baseline at 3 months in intervention compared to control
measure: Change in Asthma Control
timeFrame: Continuous change over time from baseline at 4 months in intervention compared to control
measure: Change in Asthma Control
timeFrame: Continuous change over time from baseline at 5 months in intervention compared to control
measure: Asthma Symptoms, Quality of Life, Treatment Barriers
timeFrame: Baseline
measure: Change in Asthma Symptoms, Quality of Life, Treatment Barriers
timeFrame: Change from Baseline at month 1
measure: Change in Asthma Symptoms, Quality of Life, Treatment Barriers
timeFrame: Continuous change over time from baseline at 2 months in intervention compared to control
measure: Change in Asthma Symptoms, Quality of Life, Treatment Barriers
timeFrame: Continuous change over time from baseline at 3 months in intervention compared to control
measure: Change in Asthma Symptoms, Quality of Life, Treatment Barriers
timeFrame: Continuous change over time from baseline at 4 months in intervention compared to control
measure: Change in Asthma Symptoms, Quality of Life, Treatment Barriers
timeFrame: Continuous change over time from baseline at 5 months in intervention compared to control
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Professor of Pediatrics
name: Maria T. Britto, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dodds CM, Britto MT. Learnings from a pragmatic pilot trial of text messaging for high-risk adolescents with asthma. Ann Allergy Asthma Immunol. 2018 May;120(5):546-547. doi: 10.1016/j.anai.2018.02.008. Epub 2018 Feb 9. No abstract available.