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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03032159
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : March 20, 2020
Sponsor:
Collaborator:
MultiCare Mary Bridge Children's Hospital & Health Center
Information provided by (Responsible Party):
Tumaini Coker, Seattle Children's Hospital

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).

Condition or disease Intervention/treatment Phase
Asthma Behavioral: Text2Breathe Study Group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 221 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Text2Breathe: Enhance Parent Communication to Reduce Pediatric Asthma Disparities
Study Start Date : August 2015
Actual Primary Completion Date : March 2020
Actual Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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



Primary Outcome Measures :
  1. Number of emergency department visits for asthma care [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Asthma morbidity measured as the number of days (or nights) of impairment. [ Time Frame: 12 months ]

Other Outcome Measures:
  1. Number of scheduled asthma care visits [ Time Frame: 12 months ]
  2. Asthma Self-Management Questionnaire standardized score [ Time Frame: 12 months ]
    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.

  3. Parental expectations for child's asthma treatment average score [ Time Frame: 12 months ]
    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).

  4. Parental self-efficacy for communicating with healthcare providers self-competence scale summary score [ Time Frame: 12 months ]
    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."

  5. Parental asthma management self-efficacy scale summary score [ Time Frame: 12 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032159


Locations
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United States, Washington
Seattle Children's
Seattle, Washington, United States, 98105
Mary Bridge Children's Hospital at Multi Care Health System
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Seattle Children's Hospital
MultiCare Mary Bridge Children's Hospital & Health Center
Investigators
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Principal Investigator: Tumaini Coker, MD, MBA Seattle Children's Hospital and Research Institute
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Responsible Party: Tumaini Coker, Professor, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT03032159    
Other Study ID Numbers: 15488
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: March 20, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases