Persistent AsthmaACT MeNCT02176694

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

A study testing Text Messaging in people with Persistent Asthma, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 12 to 21 years
Conditions the study is for: Persistent Asthma
What is being tested?: Text Messaging
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 1 siteUnited States
Study dates: Jun 2014to Dec 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 21 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Persistent Asthma
Being tested: Text Messaging
Keywords: persistent asthma, adherence, text message reminders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Text MessagingBehavioural
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.

Study groups in NCT02176694
Study group	Role	What they receive
Standard Care	No intervention	Aside from the asthma education provided at enrollment and placement of the SmartInhaler (i.e.,electronic monitoring device), adolescents will continue to receive usual care through their primary care providers.
Text Messaging	Experimental	A technology based system which allows adolescents to compose, schedule and send one-time or recurring text messages to their own cell phones. Receives: Behavioral: Text Messaging

What is being measured

The primary outcome is the main question the study is designed to answer.

Objective Adherence to ICS
Electronic monitor logs
Measured: Baseline
Change in objective adherence to ICS
Electronic Monitor Logs
Measured: Change from baseline in objective adherence to ICS at 1 month
Change in objective adherence to ICS
Electronic Monitor Logs
Measured: Continuous change over time from baseline in objective adherence to ICS at 2 months in intervention compared to control
Change in objective adherence to ICS
Electronic Monitor Logs
Measured: Continuous change over time from baseline in objective adherence to ICS at 3 months in intervention compared to control
Change in objective adherence to ICS
Electronic Monitor Logs
Measured: Continuous change over time from baseline in objective adherence to ICS at 4 months in intervention compared to control
Change in objective adherence to ICS
Electronic Monitor Logs
Measured: Continuous change over time from baseline in objective adherence to ICS at 5 months in intervention compared to control
Feasibility, Acceptability and Usability of the Text Messaging Website
The 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.
Measured: At time of text messaging intervention
Feasibility, Acceptability and Usability of the Text Messaging Website
The 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.
Measured: up to 1 month after receiving text messages
Feasibility, Acceptability and Usability of the Text Messaging Website
The 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.
Measured: up to 2 months after receiving text messages
Feasibility, Acceptability and Usability of the Text Messaging Website
The 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.
Measured: up to 3 months after receiving text messages

Secondary outcomes (12)

Asthma Control
The 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.
Measured: Baseline
Change in Asthma Control
The 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.
Measured: Change from Baseline at 1 month
Change in Asthma Control
The 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.
Measured: Continuous change over time from baseline at 2 months in intervention compared to control
Change in Asthma Control
The 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.
Measured: Continuous change over time from baseline at 3 months in intervention compared to control
Change in Asthma Control
The 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.
Measured: Continuous change over time from baseline at 4 months in intervention compared to control
Change in Asthma Control
The 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.
Measured: Continuous change over time from baseline at 5 months in intervention compared to control
Asthma Symptoms, Quality of Life, Treatment Barriers
The 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.
Measured: Baseline
Change in Asthma Symptoms, Quality of Life, Treatment Barriers
The 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.
Measured: Change from Baseline at month 1
Change in Asthma Symptoms, Quality of Life, Treatment Barriers
The 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.
Measured: Continuous change over time from baseline at 2 months in intervention compared to control
Change in Asthma Symptoms, Quality of Life, Treatment Barriers
The 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.
Measured: Continuous change over time from baseline at 3 months in intervention compared to control
Change in Asthma Symptoms, Quality of Life, Treatment Barriers
The 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.
Measured: Continuous change over time from baseline at 4 months in intervention compared to control
Change in Asthma Symptoms, Quality of Life, Treatment Barriers
The 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.
Measured: Continuous change over time from baseline at 5 months in intervention compared to control

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Dec 2015

First posted27 Jun 2014 (estimated)
Study startJun 2014
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Persistent AsthmaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02176694
Sponsor's protocol ID: 2013-1184
Other IDs: 1R21HL119826-01
Acronym: ACT Me
Status last verified: Jun 2016
First submitted: 9 Jun 2014
Last updated: 10 Jun 2016
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 29432968

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Persistent Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Adolescent Controlled Text Messaging to Improve Asthma Medication Adherence in Primary Care.
ClinicalTrials.gov ID: NCT02176694
Acronym / sponsor ID: ACT Me / 2013-1184
Conditions: Persistent Asthma
Keywords: persistent asthma, adherence, text message reminders
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: Jun 2014
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 27 Jun 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Standard Care	No intervention	–Aside from the asthma education provided at enrollment and placement of the SmartInhaler (i.e.,electronic monitoring device), adolescents will continue to receive usual care through their primary care providers.
Text Messaging	Experimental	Behavioral: Text MessagingA technology based system which allows adolescents to compose, schedule and send one-time or recurring text messages to their own cell phones.

Who may qualify

Ages: 12 to 21 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Text MessagingWebsite 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.	Behavioural	Text Messaging

Primary outcome

Objective Adherence to ICS
Time frame: Baseline
Electronic monitor logs
Change in objective adherence to ICS
Time frame: Change from baseline in objective adherence to ICS at 1 month
Electronic Monitor Logs
Change in objective adherence to ICS
Time frame: Continuous change over time from baseline in objective adherence to ICS at 2 months in intervention compared to control
Electronic Monitor Logs
Change in objective adherence to ICS
Time frame: Continuous change over time from baseline in objective adherence to ICS at 3 months in intervention compared to control
Electronic Monitor Logs
Change in objective adherence to ICS
Time frame: Continuous change over time from baseline in objective adherence to ICS at 4 months in intervention compared to control
Electronic Monitor Logs
Change in objective adherence to ICS
Time frame: Continuous change over time from baseline in objective adherence to ICS at 5 months in intervention compared to control
Electronic Monitor Logs
Feasibility, Acceptability and Usability of the Text Messaging Website
Time frame: At time of text messaging intervention
The 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.
Feasibility, Acceptability and Usability of the Text Messaging Website
Time frame: up to 1 month after receiving text messages
The 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.
Feasibility, Acceptability and Usability of the Text Messaging Website
Time frame: up to 2 months after receiving text messages
The 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.
Feasibility, Acceptability and Usability of the Text Messaging Website
Time frame: up to 3 months after receiving text messages
The 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.

12 secondary outcomes

Asthma Control
Time frame: Baseline
Change in Asthma Control
Time frame: Change from Baseline at 1 month
Change in Asthma Control
Time frame: Continuous change over time from baseline at 2 months in intervention compared to control
Change in Asthma Control
Time frame: Continuous change over time from baseline at 3 months in intervention compared to control
Change in Asthma Control
Time frame: Continuous change over time from baseline at 4 months in intervention compared to control
Change in Asthma Control
Time frame: Continuous change over time from baseline at 5 months in intervention compared to control
Asthma Symptoms, Quality of Life, Treatment Barriers
Time frame: Baseline
Change in Asthma Symptoms, Quality of Life, Treatment Barriers
Time frame: Change from Baseline at month 1
Change in Asthma Symptoms, Quality of Life, Treatment Barriers
Time frame: Continuous change over time from baseline at 2 months in intervention compared to control
Change in Asthma Symptoms, Quality of Life, Treatment Barriers
Time frame: Continuous change over time from baseline at 3 months in intervention compared to control
Change in Asthma Symptoms, Quality of Life, Treatment Barriers
Time frame: Continuous change over time from baseline at 4 months in intervention compared to control
Change in Asthma Symptoms, Quality of Life, Treatment Barriers
Time frame: Continuous change over time from baseline at 5 months in intervention compared to control

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2016.
Derived from this study: PubMed 29432968Dodds 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.

Related trials for Persistent Asthma

RecruitingObservational study
Expression of TSLP Isoforms in Asthma
Asthma Atopic, Asthma Severe Persistent Uncontrolled
Not yet recruitingPhase 1
Anakinra Rescue Treatment for Moderate Asthma Attacks (ARTMA)
Asthma (Diagnosis), Persistent Asthma
Not yet recruiting
THERMotherapy Against Persistent Bacterial LUNG Infections
Lung Diseases, Obstructive, Bronchiectasis
Not yet recruiting
Improving the Quality of Care for Asthma Patients at Risk of Exacerbations
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RecruitingPhase 2
Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma Patients
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Maria T. Britto, M.D., M.P.H. principal investigator

Professor of Pediatrics

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Text Messaging in people with Persistent Asthma, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Adherence to ICS (time frame: Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02176694, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2016.