Recruiting

Observational Study

Sponsor:

Children's Hospitals and Clinics of Minnesota

Code:

NCT02436070

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 4 - 17

Healthy Volunteers: Not accepted

Interventions

Targeted text messages

General text messages

Study Details

Brief 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.)

Conditions

Asthma

Study ID

NCT02436070

Start date

Oct, 2014

Status verified date

Nov, 2017

Completion date

Dec, 2018

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 17

Healthy Volunteers: Not accepted

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

Enrollment

195 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Control

Subjects receive general, health-related text messages applicable for children with asthma.

experimental: Test group

Subjects receive specific, targeted text messages for post-emergency department discharge asthma care.

Interventions

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

Primary outcome measure

  • Follow-up care with primary care provider [ Time Frame: 1 week after emergency department discharge ]

Central Contacts and Locations

Central contacts

Locations

Children's Hospitals and Clinics of Minnesota - Emergency Department

Recruiting

Minneapolis, Minnesota, United States, 55404

Children's Minnesota

Recruiting

Saint Paul, Minnesota, United States

More Information

Sponsor

Children's Hospitals and Clinics of Minnesota

Last update posted

Nov 22, 2017

Last verified

Nov, 2017

Keywords

  • Pediatrics
  • Emergency Medicine
  • Text messaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospitals and Clinics of Minnesota on 2017-11-22.