Trial Outcomes & Findings for Text2Breathe: Enhance Parent Communication to Reduce Pediatric Asthma Disparities (NCT NCT03032159)

Results Overview

Number of emergency department visits for asthma care

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

221 participants

Primary outcome timeframe

12 months

Results posted on

2024-12-03

Participant Flow

Participants (parents) were recruited from two children's hospitals in Seattle and Tacoma, Washington from 2015-2019.

Of the 661 potential parent participants screened for eligibility, 221 were eligible and randomized. Participants are unique parent/child dyads. The parents were enrolled, and each parent had a child that they provided data on. Those that were screened but excluded either did not meet inclusion criteria or declined to participate.

Participant milestones

Participant milestones
Measure	Control Group Parents randomized to the control group child will receive their usual asthma care from their provider. Additionally, participants (parents) in the control group will receive reminder texts to schedule with their child's primary care provider (PCP) and to get an annual flu shot. Participants (parents) will be surveyed over the phone for 20-30 minutes 3, 6, 12, 18, and 24 months after enrollment.	Text2Breathe Study Group Parents in the "study" group spend about 10-20 minutes learning about ways to have better communication with their child's primary care provider about his/her asthma. Additionally, parents in this group were enrolled in the Text2Breathe messaging program which sends asthma related educational text messages 2 times a week for 3 months. Paret 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. Parents will be surveyed over the phone for 20-30 minutes 3, 6, 12, 18, and 24 months after enrollment. Text2Breathe Study Group
Overall Study STARTED	110	111
Overall Study COMPLETED	91	77
Overall Study NOT COMPLETED	19	34

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Text2Breathe: Enhance Parent Communication to Reduce Pediatric Asthma Disparities

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=110 Participants Parents randomized to the control group child will receive their usual asthma care from their provider. Additionally, parents in the control group will receive reminder texts to schedule with their child's PCP and to get an annual flu shot. Parents will be surveyed over the phone for 20-30 minutes 3, 6, 12, 18, and 24 months after enrollment.	Text2Breathe Study Group n=111 Participants Parents in the "study" group spend about 10-20 minutes learning about ways to have better communication with their child's primary care provider about his/her asthma. Additionally, parents in this group enrolled in the Text2Breathe messaging program which sends asthma related educational text messages 2 times a week for 3 months. Parents randomized to the study group will also receive reminder texts to schedule with their child's PCP and to get an annual flu shot. Parents will be surveyed over the phone for 20-30 minutes 3, 6, 12, 18, and 24 months after enrollment. Text2Breathe Study Group	Total n=221 Participants Total of all reporting groups
Age, Continuous	5.0 years STANDARD_DEVIATION 2.3 • n=5 Participants	6.4 years STANDARD_DEVIATION 2.9 • n=7 Participants	5.8 years STANDARD_DEVIATION 2.7 • n=5 Participants
Sex: Female, Male Female	97 Participants n=5 Participants	101 Participants n=7 Participants	198 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Race/Ethnicity, Customized Parent race and ethnicity · Latino	35 Participants n=5 Participants	36 Participants n=7 Participants	71 Participants n=5 Participants
Race/Ethnicity, Customized Parent race and ethnicity · Non-Latino Black	24 Participants n=5 Participants	18 Participants n=7 Participants	42 Participants n=5 Participants
Race/Ethnicity, Customized Parent race and ethnicity · Multiracial	2 Participants n=5 Participants	12 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Parent race and ethnicity · Non-Latino White	32 Participants n=5 Participants	28 Participants n=7 Participants	60 Participants n=5 Participants
Race/Ethnicity, Customized Parent race and ethnicity · Other	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Race/Ethnicity, Customized Parent race and ethnicity · Missing	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	110 participants n=5 Participants	111 participants n=7 Participants	221 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Number of emergency department visits for asthma care

Outcome measures

Outcome measures
Measure	Control Group n=91 Participants 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 n=77 Participants 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. Text2Breathe Study Group
Emergency Department Visits for Asthma Care	1.65 ED visits Standard Deviation 1.7	1.95 ED visits Standard Deviation 2.7

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

Outcome measures
Measure	Control Group n=91 Participants 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 n=77 Participants 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. Text2Breathe Study Group
Asthma Morbidity	3.36 max symptom days Standard Deviation 4.4	4.45 max symptom days Standard Deviation 5.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Number of visits with PCP for preventative asthma care in past 12 months

Outcome measures

Outcome measures
Measure	Control Group n=91 Participants 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 n=77 Participants 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. Text2Breathe Study Group
Number of Scheduled Asthma Care Visits	2.07 number of visits Standard Deviation 1.7	2.80 number of visits Standard Deviation 3.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control Group n=91 Participants 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 n=77 Participants 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. Text2Breathe Study Group
Asthma Self-Management Questionnaire Standardized Score	59.68 score on a scale Standard Deviation 17.2	58.67 score on a scale Standard Deviation 19.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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."

Outcome measures

Outcome measures
Measure	Control Group n=91 Participants 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 n=77 Participants 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. Text2Breathe Study Group
Parental Self-efficacy for Communicating With Healthcare Providers Self-competence Scale Summary Score	78.72 score on a scale Standard Deviation 3.1	78.63 score on a scale Standard Deviation 3.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Text2Breathe Study Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tumaini R. Coker, MD, MBA

Seattle Children's

Phone: 206-884-0559

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place