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Adolescent Controlled Text Messaging to Improve Asthma Medication Adherence in Primary Care

Adolescent Controlled Text Messaging to Improve Asthma Medication Adherence in Primary Care.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02176694
Acronym
ACT Me
Enrollment
29
Registered
2014-06-27
Start date
2014-06-30
Completion date
2015-12-31
Last updated
2016-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent Asthma

Keywords

persistent asthma, adherence, text message reminders

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.

Interventions

BEHAVIORALText Messaging

Website that allows adolescents to create, schedule and send one-time or recurring text messages that will serve as a reminder to take asthma medication or follow up with another health-related matter.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Children's Hospital Medical Center, Cincinnati
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
12 Years to 21 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Objective Adherence to ICSBaselineElectronic monitor logs
Change in objective adherence to ICSChange from baseline in objective adherence to ICS at 1 monthElectronic Monitor Logs
Feasibility, Acceptability and Usability of the Text Messaging WebsiteAt time of text messaging interventionThe Computer System Usability Questionnaire is a self-reported measure that captures quantitative data about the usability of the computer system. The Cincinnati Bell Usability questionnaire is a self-reported measure that captures quantitative and qualitative data about how easy the system is to use, whether they like using it, as well as likes and dislikes. Use of the computer system is determined through CMSText website login and message logs.

Secondary

MeasureTime frameDescription
Asthma ControlBaselineThe Asthma Control Test (ACT) are questions that ask about frequency of day and night symptoms, frequency of fast acting inhaler use, environmental triggers, limitations of activities, perception of asthma control, and confidence in ability to manage asthma.
Change in Asthma Symptoms, Quality of Life, Treatment BarriersChange from Baseline at month 1The Pediatric Quality of Life (PEDSQL) Asthma Symptom Scale, the generic core scale and the treatment barriers scale are questions that assess how much asthma has been a problem for them in the last month.
Change in Asthma ControlChange from Baseline at 1 monthThe Asthma Control Test (ACT) are questions that ask about frequency of day and night symptoms, frequency of fast acting inhaler use, environmental triggers, limitations of activities, perception of asthma control, and confidence in ability to manage asthma.
Asthma Symptoms, Quality of Life, Treatment BarriersBaselineThe Pediatric Quality of Life (PEDSQL) Asthma Symptom Scale, the generic core scale and the treatment barriers scale are questions that assess how much asthma has been a problem for them in the last month.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026