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
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Behavioral: Text2Breathe Study Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||221 participants|
|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|
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
- Number of emergency department visits for asthma care [ Time Frame: 12 months ]
- Asthma morbidity measured as the number of days (or nights) of impairment. [ Time Frame: 12 months ]
- Number of scheduled asthma care visits [ Time Frame: 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. 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.
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
|United States, Washington|
|Seattle, Washington, United States, 98105|
|Mary Bridge Children's Hospital at Multi Care Health System|
|Tacoma, Washington, United States, 98405|
|Principal Investigator:||Tumaini Coker, MD, MBA||Seattle Children's Hospital and Research Institute|