NCT02436070

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.)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
195

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

November 22, 2017

Status Verified

November 1, 2017

Enrollment Period

4.2 years

First QC Date

May 1, 2015

Last Update Submit

November 20, 2017

Conditions

Keywords

PediatricsEmergency MedicineText messaging

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Influenza vaccine

    30 days after emergency department discharge

  • Return visit to the emergency department

    30 days after the inaugural emergency department visit

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Behavioral: General text messages

Test group

EXPERIMENTAL

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

Behavioral: Targeted text messages

Interventions

Subjects received text messages specific to post ED asthma follow-up

Test group

Subjects received text messages generalized to children with asthma

Control

Eligibility Criteria

Age4 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Pulmonary hypertension
  • Other chronic lung disease
  • Current cancer diagnosis
  • Previous cardiovascular surgery
  • Inflammatory bowel disease
  • Sickle Cell disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hospitals and Clinics of Minnesota - Emergency Department

Minneapolis, Minnesota, 55404, United States

RECRUITING

Children's Minnesota

Saint Paul, Minnesota, United States

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2015

First Posted

May 6, 2015

Study Start

October 1, 2014

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

November 22, 2017

Record last verified: 2017-11

Locations