Asthma
Conditions
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.
Interventions
BEHAVIORALText2Breathe Study Group
Sponsors
MultiCare Mary Bridge Children's Hospital & Health Center
Seattle Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emergency Department Visits for Asthma Care | 12 months | Number of emergency department visits for asthma care |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Morbidity | 12 months | Asthma morbidity measured as the number of days (or nights) of impairment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Parental Expectations for Child's Asthma Treatment Average Score | 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). |
| Number of Scheduled Asthma Care Visits | 12 months | Number of visits with PCP for preventative asthma care in past 12 months |
| Parental Asthma Management Self-efficacy Scale Summary Score | 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. |
| Parental Self-efficacy for Communicating With Healthcare Providers Self-competence Scale Summary Score | 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. |
| Asthma Self-Management Questionnaire Standardized Score | 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. |
Countries
United States
Participant flow
Recruitment details
Participants (parents) were recruited from two children's hospitals in Seattle and Tacoma, Washington from 2015-2019.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Control Group 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. | 110 |
| 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 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 | 111 |
| Total | 221 |
Baseline characteristics
| Characteristic | Control Group | Text2Breathe Study Group | Total |
|---|---|---|---|
| Age, Continuous | 5.0 years STANDARD_DEVIATION 2.3 | 6.4 years STANDARD_DEVIATION 2.9 | 5.8 years STANDARD_DEVIATION 2.7 |
| Race/Ethnicity, Customized Parent race and ethnicity Latino | 35 Participants | 36 Participants | 71 Participants |
| Race/Ethnicity, Customized Parent race and ethnicity Missing | 2 Participants | 6 Participants | 8 Participants |
| Race/Ethnicity, Customized Parent race and ethnicity Multiracial | 2 Participants | 12 Participants | 14 Participants |
| Race/Ethnicity, Customized Parent race and ethnicity Non-Latino Black | 24 Participants | 18 Participants | 42 Participants |
| Race/Ethnicity, Customized Parent race and ethnicity Non-Latino White | 32 Participants | 28 Participants | 60 Participants |
| Race/Ethnicity, Customized Parent race and ethnicity Other | 15 Participants | 11 Participants | 26 Participants |
| Region of Enrollment United States | 110 participants | 111 participants | 221 participants |
| Sex: Female, Male Female | 97 Participants | 101 Participants | 198 Participants |
| Sex: Female, Male Male | 13 Participants | 10 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 110 | 0 / 111 |
| other Total, other adverse events | 0 / 110 | 0 / 111 |
| serious Total, serious adverse events | 0 / 110 | 0 / 111 |
Outcome results
Primary
Emergency Department Visits for Asthma Care
Number of emergency department visits for asthma care
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Emergency Department Visits for Asthma Care | 1.65 ED visits | Standard Deviation 1.7 |
| Text2Breathe Study Group | Emergency Department Visits for Asthma Care | 1.95 ED visits | Standard Deviation 2.7 |
Secondary
Asthma Morbidity
Asthma morbidity measured as the number of days (or nights) of impairment.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Asthma Morbidity | 3.36 max symptom days | Standard Deviation 4.4 |
| Text2Breathe Study Group | Asthma Morbidity | 4.45 max symptom days | Standard Deviation 5 |
Other Pre-specified
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Asthma Self-Management Questionnaire Standardized Score | 59.68 score on a scale | Standard Deviation 17.2 |
| Text2Breathe Study Group | Asthma Self-Management Questionnaire Standardized Score | 58.67 score on a scale | Standard Deviation 19.6 |
Other Pre-specified
Number of Scheduled Asthma Care Visits
Number of visits with PCP for preventative asthma care in past 12 months
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Number of Scheduled Asthma Care Visits | 2.07 number of visits | Standard Deviation 1.7 |
| Text2Breathe Study Group | Number of Scheduled Asthma Care Visits | 2.80 number of visits | Standard Deviation 3 |
Other Pre-specified
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.
Time frame: 12 months
Other Pre-specified
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).
Time frame: 12 months
Other Pre-specified
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 (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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Parental Self-efficacy for Communicating With Healthcare Providers Self-competence Scale Summary Score | 78.72 score on a scale | Standard Deviation 3.1 |
| Text2Breathe Study Group | Parental Self-efficacy for Communicating With Healthcare Providers Self-competence Scale Summary Score | 78.63 score on a scale | Standard Deviation 3.1 |