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

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text2Breathe Study Group
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seattle Children's
  • Mary Bridge Children's Hospital at Multi Care Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Text2Breathe Study Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of emergency department visits for asthma care

Secondary Outcome Measures

Asthma morbidity measured as the number of days (or nights) of impairment.

Full Information

First Posted
April 20, 2016
Last Updated
March 19, 2020
Sponsor
Seattle Children's Hospital
Collaborators
MultiCare Mary Bridge Children's Hospital & Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT03032159
Brief Title
Text2Breathe: Enhance Parent Communication to Reduce Pediatric Asthma Disparities
Acronym
T2B
Official Title
Text2Breathe: Enhance Parent Communication to Reduce Pediatric Asthma Disparities
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
March 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital
Collaborators
MultiCare Mary Bridge Children's Hospital & Health Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
221 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Text2Breathe Study Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Text2Breathe Study Group
Primary Outcome Measure Information:
Title
Number of emergency department visits for asthma care
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Asthma morbidity measured as the number of days (or nights) of impairment.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Number of scheduled asthma care visits
Time Frame
12 months
Title
Asthma Self-Management Questionnaire standardized score
Description
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.
Time Frame
12 months
Title
Parental expectations for child's asthma treatment average score
Description
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).
Time Frame
12 months
Title
Parental self-efficacy for communicating with healthcare providers self-competence scale summary score
Description
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. 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."
Time Frame
12 months
Title
Parental asthma management self-efficacy scale summary score
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tumaini Coker, MD, MBA
Organizational Affiliation
Seattle Children's Hospital and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle Children's
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Mary Bridge Children's Hospital at Multi Care Health System
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Text2Breathe: Enhance Parent Communication to Reduce Pediatric Asthma Disparities

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