NCT Number: NCT03032159
Text2Breathe: Enhance Parent Communication to Reduce Pediatric Asthma Disparities
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).
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Seattle Children's, Seattle, Washington, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Emergency Department Visits for Asthma Care
Time frame: 12 months
Number of emergency department visits for asthma care
Secondary outcomes
-
Asthma Morbidity
Time frame: 12 months
Asthma morbidity measured as the number of days (or nights) of impairment.
Other outcomes
-
Number of Scheduled Asthma Care Visits
Time frame: 12 months
Number of visits with PCP for preventative asthma care in past 12 months
-
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.
-
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).
-
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 (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."
-
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.
Sponsors and collaborators
Lead sponsor
Seattle Children's Hospital
Other
Collaborators
- MultiCare Mary Bridge Children's Hospital & Health Center
Registry information
Acronym: T2B
Important dates
- Study start
- 2015
- Primary completion
- 2020
- Study completion
- 2020
- First posted
- Jan 26, 2017
- Registry last updated
- Dec 3, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
A Community-Based Swimming and Inspiratory Muscle Training Intervention to Promote Physical Activity and Asthma Control in Children With Mild Asthma
NCT07394127
Asthma, Asthma Chronic
Gümüşhane, Trabzon, Ordu, Giresun, Rize, Artvin, Gümüşhane, Turkey (Türkiye)
View Trial DetailsThe COX-2 Gene and the Immune System
NCT01678222
Allergic Inflammation, Asthma
Research Triangle Park, North Carolina, United States
View Trial DetailsNew Approaches for Empowering Studies of Asthma in Populations of African Descent
NCT03937804
Asthma, Bronchial Diseases
Bethesda, Maryland, United States
View Trial DetailsA Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)
NCT03927820
Asthma, Bronchial Diseases
Nashville, Tennessee, United States
View Trial Details