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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02436070
Other study ID # 1409-082
Secondary ID
Status Recruiting
Phase N/A
First received May 1, 2015
Last updated November 20, 2017
Start date October 2014
Est. completion date December 2018

Study information

Verified date November 2017
Source Children's Hospitals and Clinics of Minnesota
Contact Heidi Vander Velden
Phone 6128137892
Email heidi.vandervelden@childrensmn.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.)


Recruitment information / eligibility

Status Recruiting
Enrollment 195
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 4 Years to 17 Years
Eligibility Inclusion Criteria:

- Caregivers of patients aged 4 - 17 years (inclusive) will be eligible for study participation if they meet the following criteria:

1. Presentation to the ED with a chief complaint related to an asthma exacerbation such as shortness of breath, respiratory distress, wheezing, etc…

2. Receive an albuterol treatment in the ED

3. Previous history of asthma as represented in the medical record or by parental report

4. Have a cell phone that is able to receive text messages

5. Able to communicate and provide consent in English or Spanish

Exclusion Criteria:

- Caregivers of patients will be excluded from this study for the following reasons:

1. First episode of wheezing

2. Admitted to the hospital

3. Co-morbid respiratory disease:

1. Cystic fibrosis

2. Bronchiectasis

3. Pulmonary hypertension

4. Other chronic lung disease

4. Current cancer diagnosis

5. Previous cardiovascular surgery

6. Inflammatory bowel disease

7. Sickle Cell disease

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Targeted text messages
Subjects received text messages specific to post ED asthma follow-up
General text messages
Subjects received text messages generalized to children with asthma

Locations

Country Name City State
United States Children's Hospitals and Clinics of Minnesota - Emergency Department Minneapolis Minnesota
United States Children's Minnesota Saint Paul Minnesota

Sponsors (2)

Lead Sponsor Collaborator
Children's Hospitals and Clinics of Minnesota HealthPartners Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Follow-up care with primary care provider Assessed via text and follow-up call if no response to text message 1 week after emergency department discharge
Secondary Influenza vaccine Assessed via text and follow-up call if no response to text message 30 days after emergency department discharge
Secondary 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 30 days after the inaugural emergency department visit
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