NCT03032159

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
221

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2016

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 26, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

November 1, 2024

Completed
Last Updated

December 3, 2024

Status Verified

November 1, 2024

Enrollment Period

4.6 years

First QC Date

April 20, 2016

Results QC Date

January 23, 2024

Last Update Submit

November 9, 2024

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Emergency Department Visits for Asthma Care

    Number of emergency department visits for asthma care

    12 months

Secondary Outcomes (1)

  • Asthma Morbidity

    12 months

Other Outcomes (5)

  • Number of Scheduled Asthma Care Visits

    12 months

  • Asthma Self-Management Questionnaire Standardized Score

    12 months

  • Parental Expectations for Child's Asthma Treatment Average Score

    12 months

  • +2 more other outcomes

Study Arms (2)

Control Group

NO INTERVENTION

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.

Text2Breathe Study Group

EXPERIMENTAL

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

Interventions

Text2Breathe Study GroupBEHAVIORAL
Text2Breathe Study Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unlimited text messaging
  • Is the parent of child who is:
  • Receiving asthma related care in the emergency department
  • years old inclusive
  • Medicaid insured (no Private insurance)
  • Physician diagnosed asthma for at least 12 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seattle Children's

Seattle, Washington, 98105, United States

Location

Mary Bridge Children's Hospital at Multi Care Health System

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Tumaini R. Coker, MD, MBA
Organization
Seattle Children's
Tumaini.Coker@seattlechildrens.org
206-884-0559

Study Officials

  • Tumaini Coker, MD, MBA

    Seattle Children's Hospital and Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 20, 2016

First Posted

January 26, 2017

Study Start

August 1, 2015

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

December 3, 2024

Results First Posted

November 1, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(2)