AsthmaNCT02436070
Use of Text Messages to Improve Care For Children Following an ED Visit for Asthma
A study testing Targeted text messages and General text messages in people with Asthma, run by Children's Hospitals and Clinics of Minnesota at 2 sites in United States.
Trial summary
BACKGROUND Asthma is a prevalent and troublesome pediatric condition. In 2013, Emergency Department (ED) providers treated over 3,500 cases of asthma-related complaints at Children's Hospitals and Clinics of Minnesota. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- Targeted text messages and General text messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2014to Dec 2018
- 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Caregivers of patients aged 4 - 17 years (inclusive) will be eligible for study participation if they meet the following criteria:
- Presentation to the ED with a chief complaint related to an asthma exacerbation such as shortness of breath, respiratory distress, wheezing, etc…
- Receive an albuterol treatment in the ED
- Previous history of asthma as represented in the medical record or by parental report
- Have a cell phone that is able to receive text messages
- Able to communicate and provide consent in English or Spanish
Who cannot join
- Caregivers of patients will be excluded from this study for the following reasons:
- First episode of wheezing
- Admitted to the hospital
- Co-morbid respiratory disease:
- Cystic fibrosis
- Bronchiectasis
Show all 12Show fewer
- Pulmonary hypertension
- Other chronic lung disease
- Current cancer diagnosis
- Previous cardiovascular surgery
- Inflammatory bowel disease
- Sickle Cell disease
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Children's Hospitals and Clinics of Minnesota - Emergency Department
Minneapolis, Minnesota, 55404
Anupam B Kharbanda, MD
- Recruiting
Children's Minnesota
Saint Paul, Minnesota
Anupam Kharbanda, MD
About this study
BACKGROUND Asthma is a prevalent and troublesome pediatric condition. In 2013, Emergency Department (ED) providers treated over 3,500 cases of asthma-related complaints at Children's Hospitals and Clinics of Minnesota. Pediatric ED visits for asthma exceeds billions of dollars annually when including direct cost and lost productivity. Many of these visits and resultant costs are avoidable. Patients with well-controlled asthma do not typically exhibit these patterns, while patients with poorly controlled asthma show patterns of increased utilization of healthcare resources and lower quality of life. Evidence suggests that a text message reminder and educational program might positively influence pediatric asthma care practices.
RESEARCH QUESTION Does a targeted ED based text message intervention program improve outpatient follow-up and routine preventive care in pediatric asthma patients?
Read more
METHODS Study subjects will be block randomized based on age and insurance group. The experimental group will receive text messages with guidance towards follow-up care with their PCP and the importance of the flu vaccine for children with asthma. The control group will receive a series of educational self-care and health based text messages unrelated to asthma or the flu vaccine. Some self-report of behaviors will be captured via text message response.
ANALYSIS Primary outcomes for the educational versus targeted text message groups will be compared use Chi-square tests. Additional adjustments may be applied for missing data or if, despite randomization, there is substantial imbalance between group in key covariates (eg race/ethnicity, insurance type or asthma severity.)
- Conditions
- Asthma
- Being tested
- Targeted text messages, General text messages
- Keywords
- Pediatrics, Emergency Medicine, Text messaging
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted text messagesBehavioural
Subjects received text messages specific to post ED asthma follow-up
General text messagesBehavioural
Subjects received text messages generalized to children with asthma
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Subjects receive general, health-related text messages applicable for children with asthma. Receives: Behavioral: General text messages |
| Test group | Experimental | Subjects receive specific, targeted text messages for post-emergency department discharge asthma care. Receives: Behavioral: Targeted text messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follow-up care with primary care provider
Assessed via text and follow-up call if no response to text message
Measured: 1 week after emergency department discharge
Secondary outcomes (2)
Influenza vaccine
Assessed via text and follow-up call if no response to text message
Measured: 30 days after emergency department discharge
Return visit to the emergency department
Assessed via text and follow-up call if no response to text message; Our health record also checked for return visits
Measured: 30 days after the inaugural emergency department visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospitals and Clinics of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- HealthPartners Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436070
- Sponsor's protocol ID
- 1409-082
- Status last verified
- Nov 2017
- First submitted
- 1 May 2015
- Last updated
- 22 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Text Messages to Improve Care For Children Following an ED Visit for Asthma
- ClinicalTrials.gov ID
- NCT02436070
- Acronym / sponsor ID
- 1409-082
- Conditions
- Asthma
- Keywords
- Pediatrics, Emergency Medicine, Text messaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- Children's Hospitals and Clinics of MinnesotaUniversity, hospital or other
- Collaborators
- HealthPartners Institute
- Study start
- Oct 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 6 May 2015 (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.
BACKGROUND Asthma is a prevalent and troublesome pediatric condition. In 2013, Emergency Department (ED) providers treated over 3,500 cases of asthma-related complaints at Children's Hospitals and Clinics of Minnesota. Pediatric ED visits for asthma exceeds billions of dollars annually when including direct cost and lost productivity. Many of these visits and resultant costs are avoidable. Patients with well-controlled asthma do not typically exhibit these patterns, while patients with poorly controlled asthma show patterns of increased utilization of healthcare resources and lower quality of life. Evidence suggests that a text message reminder and educational program might positively influence pediatric asthma care practices.
RESEARCH QUESTION Does a targeted ED based text message intervention program improve outpatient follow-up and routine preventive care in pediatric asthma patients?
METHODS Study subjects will be block randomized based on age and insurance group. The experimental group will receive text messages with guidance towards follow-up care with their PCP and the importance of the flu vaccine for children with asthma. The control group will receive a series of educational self-care and health based text messages unrelated to asthma or the flu vaccine. Some self-report of behaviors will be captured via text message response.
ANALYSIS Primary outcomes for the educational versus targeted text message groups will be compared use Chi-square tests. Additional adjustments may be applied for missing data or if, despite randomization, there is substantial imbalance between group in key covariates (eg race/ethnicity, insurance type or asthma severity.)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: General text messagesSubjects receive general, health-related text messages applicable for children with asthma. |
| Test group | Experimental | Behavioral: Targeted text messagesSubjects receive specific, targeted text messages for post-emergency department discharge asthma care. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Caregivers of patients aged 4 - 17 years (inclusive) will be eligible for study participation if they meet the following criteria:
Key exclusion criteria (12 listed)
- Caregivers of patients will be excluded from this study for the following reasons:
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 |
|---|---|---|
| Targeted text messagesSubjects received text messages specific to post ED asthma follow-up | Behavioural | Test group |
| General text messagesSubjects received text messages generalized to children with asthma | Behavioural | Control |
Primary outcome
Follow-up care with primary care provider
Time frame: 1 week after emergency department discharge
Assessed via text and follow-up call if no response to text message
2 secondary outcomes
Influenza vaccine
Time frame: 30 days after emergency department discharge
Return visit to the emergency department
Time frame: 30 days after the inaugural emergency department visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2017.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted text messages and General text messages in people with Asthma, run by Children's Hospitals and Clinics of Minnesota at 2 sites 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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 22 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heidi Vander Velden (6128137892, heidi.vandervelden@childrensmn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Follow-up care with primary care provider (time frame: 1 week after emergency department discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2017.