Text2Breathe: Enhance Parent Communication to Reduce Pediatric Asthma Disparities

Asthma Clinical Trial

— T2B  

Official title:

Text2Breathe: Enhance Parent Communication to Reduce Pediatric Asthma Disparities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03032159
• Other study ID #: 15488
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: March 2020

Study information

• Verified date: March 2020
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• Text2Breathe Study Group

Locations

Country	Name	City	State
United States	Seattle Children's	Seattle	Washington
United States	Mary Bridge Children's Hospital at Multi Care Health System	Tacoma	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Children's Hospital	MultiCare Mary Bridge Children's Hospital & Health Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of scheduled asthma care visits		12 months
Other	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
Other	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
Other	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. 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
Other	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
Primary	Number of emergency department visits for asthma care		12 months
Secondary	Asthma morbidity measured as the number of days (or nights) of impairment.		12 months