Text2Breathe: Enhance Parent Communication to Reduce Pediatric Asthma Disparities (T2B)

Text2Breathe (T2B) is a randomized controlled trial aimed at improving communication between parents and their children's' primary care providers about asthma. The overarching goal of this study is to reduce disparities among a population with high rates of pediatric asthma morbidity. The investigators are testing the efficacy of a short message service (SMS)-enhanced health communication (HC) intervention ("Text2Breathe") designed to equip urban, low-income parents with tools for communicating effectively with their children's primary care provider (PCP).

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Behavioral: Text2Breathe Study Group

Detailed Description

Potentially eligible participants are approached and screened in person during an admission of their child to the emergency department for asthma care. Those participants randomized to the intervention will receive additional education on effective communication with their child's primary care provider (PCP). These participants will also receive educational text messages for three months after their initial visit. Text messages will include education on effectively communicating with their child's provider and general asthma information. Both the control group and intervention group will receive text message reminders to schedule regular follow up visits with their PCP and get an annual flu shot. Both groups will be contacted for follow up phone interviews at 3, 6, 12, 18 and 24 months.

• Study Type: Interventional
• Enrollment (Actual): 221
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's
    • Tacoma, Washington, United States, 98405
      • Mary Bridge Children's Hospital at Multi Care Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Unlimited text messaging

Is the parent of child who is:

• Receiving asthma related care in the emergency department
• 2-12 years old inclusive
• Medicaid insured (no Private insurance)
• Physician diagnosed asthma for at least 12 months

Exclusion Criteria:

Is the parent of child who:

• Has seen a pulmonary or allergy sub-specialist more than once in the last 6 months
• Has seen a sub-specialist (not pulmonary or allergy) more than once in the last 12 months
• Has been hospitalized for more than 30 days
• Is currently enrolled in another asthma program or study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Participants randomized to the control group will receive their usual asthma care from their provider. Additionally, participants in the control group will receive reminder texts to schedule with their child's PCP and to get an annual flu shot. Participants will be surveyed over the phone for 20-30 minutes 3, 6, 12, 18, and 24 months after enrollment.
Experimental: Text2Breathe Study Group; The "study" group spends about 10-20 minutes learning about ways to have better communication with their child's primary care provider about his/her asthma. Additionally this group is enrolled in the Text2Breathe messaging program which sends asthma related educational text messages 2 times a week for 3 months. Participants randomized to the study group will also receive reminder texts to schedule with their child's PCP and to get an annual flu shot. Participants will be surveyed over the phone for 20-30 minutes 3, 6, 12, 18, and 24 months after enrollment.	Behavioral: Text2Breathe Study Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergency Department Visits for Asthma Care	Number of emergency department visits for asthma care	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma Morbidity	Asthma morbidity measured as the number of days (or nights) of impairment.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Scheduled Asthma Care Visits	Number of visits with PCP for preventative asthma care in past 12 months	12 months
Asthma Self-Management Questionnaire Standardized Score	The Asthma Self-Management Questionnaire, recommended by experts convened for the Asthma Outcomes workshop, includes 16 multiple-choice questions regarding knowledge of preventive strategies and controller medication use. Standardized scores (0-100) are generated, with higher scores indicating more knowledge of self-management. Cronbach's alpha was 0.71. Wording of questions has been revised (e.g., "you" = "your child") to be appropriate for parents of children with asthma.	12 months
Parental Expectations for Child's Asthma Treatment Average Score	In accordance with other research of pediatric asthma interventions, to assess parents' beliefs about possible asthma quality of life for their child we will administer an 8-item measure of parental expectations for asthma treatment. Parents respond to statements about their expectations (e.g., "I believe that my child can be symptom free most of the time.") using a 5-point Likert scale (1=strongly disagree to 5=strongly agree). Total scores are calculated by averaging across responses, and higher scores reflect more optimistic asthma outcome expectations (Cronbach's alpha = 0.70).	12 months
Parental Self-efficacy for Communicating With Healthcare Providers Self-competence Scale Summary Score	The Medical Competence Communication Scale (MCCS) measures patient's perceptions of their own communication during their most recent medical visits. The patient version of the measure is used to assess information giving, seeking and verifying, as well as socio-emotional communication. The MCCS, patient version, consists of 23 items rated on a 5-point Likert scale (1= unimportant to 5= important) with a higher score indicating greater perception of communication competence (range 16-80). Cronbach's alpha ranges from 0.76-0.92 on the various subscales. Only the 16 self-competence items will be administered in this study. Wording of questions will be modified to state "my child's medical problem" rather than "my medical problem."	12 months
Parental Asthma Management Self-efficacy Scale Summary Score	The Parent Asthma Management Self-Efficacy Scale (PAMSES) is a valid and reliable instrument designed to measure parent self-efficacy in preventing and managing children's asthma attacks. The PAMSES consists of 13 items rated on a 5-point Likert scale (1=not at all sure to 5=completely sure) with a total possible score range of 13 to 65; higher scores indicate greater self-efficacy. Cronbach's alpha in a sample of primarily White mothers was 0.87.	12 months

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Collaborators: MultiCare Mary Bridge Children's Hospital & Health Center
• Investigators: Principal Investigator: Tumaini Coker, MD, MBA, Seattle Children's Hospital and Research Institute

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: April 20, 2016
• First Submitted That Met QC Criteria: January 23, 2017
• First Posted (Estimated): January 26, 2017

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 9, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: 15488

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO