Asthma in Children
Conditions
Keywords
Asthma, Adolescents, Dyads, Shared decision-making, Minority health
Brief summary
The overall aims of this study are to develop and pilot test BRief intervention to Evaluate Asthma THErapy (BREATHE)-Peds, a dyadic shared decision-making intervention, to improve asthma by supporting self-management among racial and ethnic minority early adolescents receiving care for uncontrolled asthma in federally-qualified health centers (FQHCs) in urban communities. Aim 1 (Phase I) involves developing the intervention through focus groups with early adolescents and caregivers. Aims 2 and 3 (Phase II) involve preliminary testing of the intervention through a pilot randomized controlled trial. This record is for Phase II and III only
Detailed description
Despite high asthma prevalence and morbidity among adolescents (highest among Black and Hispanic youth and early adolescents aged 10-14), there is a lack of developmentally appropriate interventions for this at-risk group. Racial and ethnic minority early adolescents have sub-optimal asthma self-management. Critical health behaviors that emerge during early adolescence affect lifelong patterns; therefore, early adolescence offers a unique opportunity to intervene. Additionally, successful self-management requires the right division of responsibility between adolescents and their caregivers. Thus, intervening simultaneously with early adolescents and their caregivers who can help support the adolescent's growing autonomy to self-manage their condition has the potential for a synergistic effect. Prior studies have demonstrated the effects of improved asthma control of BREATHE, a brief one-time shared decision-making intervention for Black adults with uncontrolled asthma that utilizes motivational interviewing delivered by primary care providers. This study (i.e., Phase II and Phase III) ) a pilot validation phase will conduct a group-randomized trial in two FQHCs with 85 dyads treated by 8 PCPs (10 dyads/PCP) randomized to 1 of 2 study arms: (a) BREATHE-PEDS-Peds (n=42 dyads), or (b) dose-matched attention control (n=43 dyads). Post-trial interviews with PCPs, caregivers, and their children to evaluate satisfaction with the intervention will be conducted; caregiver-child dyads will be followed for 3 months post-intervention to assess the impact of BREATHE-PEDS-Peds on asthma outcomes.
Interventions
BEHAVIORALBREATHE-Peds Intervention
BREATHE-Peds utilizes Primary Care Providers (PCPs) to deliver a 4-step script that was created by and tailored to Black adults' asthma and inhaled corticosteroid beliefs, as well as their Asthma Control Questionnaire (ACQ) score, measured just prior to the medical visit. Step 1: Raise the subject (1½ minute). Step 2: Provide feedback (1½ minutes). Step 3: Enhance engagement (3 minutes). Step 4: Shared decision-making (3 minutes).
BEHAVIORALControl Intervention
The control intervention will be a 9-minute scripted discussion tailored to living a health lifestyle. Step 1: Review of BMI, current diet and exercise (3 minutes). Step 2: Diet/exercise counseling (3 minutes). Step 3: Plan for goal attainment (3 minutes).
Sponsors
National Institute of Nursing Research (NINR)
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Patient participants, data collectors, and the statistician will be blinded to assignment. Consent materials will inform patient participants that the focus of the trial is on the communication they have with their clinician about asthma management and control. Immediately after the intervention, patient participants will be asked to guess the condition to which their clinician had been randomized. At the end of participants' final data collection visit, data collectors will be asked to guess whether participants had received the active or control intervention at the visit. These data will provide some measurement of the success of masking.
Eligibility
Sex/Gender
ALL
Age
10 Years to 14 Years
Healthy volunteers
Yes
Inclusion criteria
(Dyad participants): Dyad (caregiver/child) participants will 1. Early adolescents (10-14 years of age) or the caregiver of early adolescents (10-14 years of age) 2. Have or the caregiver of a child that has clinician-diagnosed persistent asthma (defined as being prescribed inhaled corticosteroids in the last 12 months) 3. Receive asthma care at a partner FQHC and 4. Child screens positive for uncontrolled asthma as measured by the Asthma Control Questionnaire- 6 items (ACQ-6) and child or caregiver has erroneous beliefs as measured by the Conventional and Alternative Management for Asthma (CAM-A) survey. Inclusion Criterion (clinicians): 1\. Those who manage a panel of pediatric asthma patients at partner FQHC.
Exclusion criteria
(Dyad participants): 1. Non-English speaking 2. Serious mental health conditions that preclude completion of study procedures or confound analyses or participation in a listening session
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Asthma Control Questionnaire Score | Up to 3 months post intervention | Asthma control as measured by improvements in Asthma Control Questionnaire (ACQ) score, a 6-item validated and widely used measure of asthma control. Each question is rated from 0 to 6. A score of 0 indicates well controlled asthma and a score of 6 indicates extremely poorly controlled asthma. The overall ACQ score is the mean score of all 6 items with scores ranging from 0 to 6. Lower mean scores indicate greater asthma control (better outcome), higher mean scores indicate lesser asthma control. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Shared Decision Making-Questionnaire-9 Score | Baseline (immediately post-intervention) | The Shared Decision Making (SDM) Questionnaire-9, is a patient reported, 9-item validated instrument that consists of nine statements that measure the decisional process in medical visits from both patients' and physicians' perspectives. Each statement is rated on a six-point scale from completely disagree (0) to completely agree (5). The raw total score of all items range from 0-45. Lower scores indicate lower levels of shared decision making between provider and patient (in this study as it pertains to asthma treatment) and higher scores indicate higher levels of shared decision making (better outcome). |
| Mean Medication Adherence Report Scale - Asthma Score | Up to 3 months post intervention | Inhaled corticosteroid adherence as measured by the Medication Adherence Report Scale - Asthma (MARS-A). Participants are asked to rate the frequency with which they engage in each of the adherence-related behaviors on a five-point scale, where 5 = never, 4 = rarely, 3 = sometimes, 2 = often and 1 = always. Scores for each item are summed to give a total score ranging from 1 to 5, with higher scores indicating higher levels of reported adherence. |
| Mean Asthma Quality of Life Questionnaire Score | Up to 3 months post intervention | Asthma quality of life improvements as measured by the Asthma Quality of Life Questionnaire (AQLQ), a 32-item validated and widely-used measure consisting of 4 domains: symptoms (11 items), emotions (5 items), environment (4 items), and activities (12 items). Each item is measured on a 7-point Likert scale (7 = not impaired at all, 1 = severely impaired). The overall AQLQ score is the mean of all 32 responses and the individual domain scores are the means of the items in those domains. The overall score ranges from 1 to 7, where lower mean scores indicate lower quality of life due to asthma (worse outcome). |
| Mean Asthma Impairment and Risk Questionnaire Score | Up to 3 months post intervention | Asthma Impairment and Risk Questionnaire (AIRQ) is a 10-item valid and reliable survey that measures bot domains of control: symptom impairments and risk for uncontrolled asthma. AIRQ™ score ranges from 0-10, measured by total number of YES answers. Score tally of 0-1 indicates well controlled asthma, scores 2-4 indicate not well controlled asthma, and scores 5-10 indicate very poorly controlled asthma. |
Countries
United States
Participant flow
Pre-assignment details
30 dyads (30 pediatric patients + 30 caregivers) were randomized to the intervention and 30 dyads (30 pediatric patients + 30 caregivers) were randomized to the control group.
Participants by arm
| Arm | Count |
|---|---|
| BREATHE-Peds Intervention (PCPs) Providers which delivered the intervention were considered participants. | 3 |
| BREATHE-Peds Intervention (Child in Dyads) The patient's primary care provider (PCP) will deliver a brief intervention using motivational interviewing and shared decision making, in a one time 9-minute intervention integrated into an office visit for asthma. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit.
BREATHE-Peds Intervention: BREATHE-Peds utilizes Primary Care Providers (PCPs) to deliver a 4-step script that was created by and tailored to Black adults' asthma and inhaled corticosteroid beliefs, as well as their Asthma Control Questionnaire (ACQ) score, measured just prior to the medical visit. Step 1: Raise the subject (1½ minute). Step 2: Provide feedback (1½ minutes). Step 3: Enhance engagement (3 minutes). Step 4: Shared decision-making (3 minutes). | 30 |
| BREATHE-Peds Intervention (Caregiver in Dyads) The patient's primary care provider (PCP) will deliver a brief intervention using motivational interviewing and shared decision making, in a one time 9-minute intervention integrated into an office visit for asthma. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit.
BREATHE-Peds Intervention: BREATHE-Peds utilizes Primary Care Providers (PCPs) to deliver a 4-step script that was created by and tailored to Black adults' asthma and inhaled corticosteroid beliefs, as well as their Asthma Control Questionnaire (ACQ) score, measured just prior to the medical visit. Step 1: Raise the subject (1½ minute). Step 2: Provide feedback (1½ minutes). Step 3: Enhance engagement (3 minutes). Step 4: Shared decision-making (3 minutes). | 30 |
| Control Intervention (PCPs) Providers which delivered the control intervention were considered participants. | 4 |
| Control Intervention (Child in Dyads) The patient's primary care provider (PCP) will deliver a 9-minute scripted intervention on credible nutrition and lifestyle information. The control intervention is designed to not be specific enough to change strategies related to asthma control.
Control Intervention: The control intervention will be a 9-minute scripted discussion tailored to living a health lifestyle. Step 1: Review of BMI, current diet and exercise (3 minutes). Step 2: Diet/exercise counseling (3 minutes). Step 3: Plan for goal attainment (3 minutes). | 30 |
| Control Intervention (Caregivers in Dyad) The patient's primary care provider (PCP) will deliver a 9-minute scripted intervention on credible nutrition and lifestyle information. The control intervention is designed to not be specific enough to change strategies related to asthma control.
Control Intervention: The control intervention will be a 9-minute scripted discussion tailored to living a health lifestyle. Step 1: Review of BMI, current diet and exercise (3 minutes). Step 2: Diet/exercise counseling (3 minutes). Step 3: Plan for goal attainment (3 minutes). | 30 |
| Total | 127 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | time off work | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | BREATHE-Peds Intervention (Child in Dyads) | BREATHE-Peds Intervention (Caregiver in Dyads) | Control Intervention (PCPs) | Control Intervention (Child in Dyads) | Control Intervention (Caregivers in Dyad) | BREATHE-Peds Intervention (PCPs) | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 30 Participants | 0 Participants | 0 Participants | 30 Participants | 0 Participants | 0 Participants | 60 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 29 Participants | 4 Participants | 0 Participants | 30 Participants | 2 Participants | 65 Participants |
| Age, Continuous | 11.3 years STANDARD_DEVIATION 0.99 | 39.43 years STANDARD_DEVIATION 8.92 | 43.75 years STANDARD_DEVIATION 13.64 | 11.1 years STANDARD_DEVIATION 0.92 | 36.86 years STANDARD_DEVIATION 6.45 | 53.33 years STANDARD_DEVIATION 13.5 | 15.03 years STANDARD_DEVIATION 12.03 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 23 Participants | 23 Participants | 1 Participants | 27 Participants | 27 Participants | 1 Participants | 102 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 6 Participants | 3 Participants | 3 Participants | 3 Participants | 2 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 7 Participants | 3 Participants | 4 Participants | 6 Participants | 0 Participants | 28 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 21 Participants | 22 Participants | 0 Participants | 26 Participants | 24 Participants | 0 Participants | 93 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Female | 16 Participants | 27 Participants | 4 Participants | 13 Participants | 29 Participants | 2 Participants | 91 Participants |
| Sex: Female, Male Male | 14 Participants | 3 Participants | 0 Participants | 16 Participants | 1 Participants | 1 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 30 | 0 / 30 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 30 | 0 / 30 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 30 | 0 / 30 | 0 / 0 |
Outcome results
Primary
Mean Asthma Control Questionnaire Score
Asthma control as measured by improvements in Asthma Control Questionnaire (ACQ) score, a 6-item validated and widely used measure of asthma control. Each question is rated from 0 to 6. A score of 0 indicates well controlled asthma and a score of 6 indicates extremely poorly controlled asthma. The overall ACQ score is the mean score of all 6 items with scores ranging from 0 to 6. Lower mean scores indicate greater asthma control (better outcome), higher mean scores indicate lesser asthma control.
Time frame: Up to 3 months post intervention
Population: Pediatric patient participants only
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BREATHE-Peds Intervention | Mean Asthma Control Questionnaire Score | Baseline | 2.7 score on a scale | Standard Deviation 0.57 |
| BREATHE-Peds Intervention | Mean Asthma Control Questionnaire Score | Month 2 | 0.80 score on a scale | Standard Deviation 0.85 |
| BREATHE-Peds Intervention | Mean Asthma Control Questionnaire Score | Month 1 | 0.98 score on a scale | Standard Deviation 0.98 |
| BREATHE-Peds Intervention | Mean Asthma Control Questionnaire Score | Month 3 | 0.95 score on a scale | Standard Deviation 1.05 |
| Control Intervention | Mean Asthma Control Questionnaire Score | Month 1 | 0.82 score on a scale | Standard Deviation 0.79 |
| Control Intervention | Mean Asthma Control Questionnaire Score | Baseline | 2.63 score on a scale | Standard Deviation 0.62 |
| Control Intervention | Mean Asthma Control Questionnaire Score | Month 3 | 0.68 score on a scale | Standard Deviation 0.76 |
| Control Intervention | Mean Asthma Control Questionnaire Score | Month 2 | 0.58 score on a scale | Standard Deviation 0.64 |
Secondary
Mean Asthma Impairment and Risk Questionnaire Score
Asthma Impairment and Risk Questionnaire (AIRQ) is a 10-item valid and reliable survey that measures bot domains of control: symptom impairments and risk for uncontrolled asthma. AIRQ™ score ranges from 0-10, measured by total number of YES answers. Score tally of 0-1 indicates well controlled asthma, scores 2-4 indicate not well controlled asthma, and scores 5-10 indicate very poorly controlled asthma.
Time frame: Up to 3 months post intervention
Population: Pediatric patient participants 12 years of age and older
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BREATHE-Peds Intervention | Mean Asthma Impairment and Risk Questionnaire Score | Baseline | 2.79 score on a scale | Standard Deviation 2.55 |
| BREATHE-Peds Intervention | Mean Asthma Impairment and Risk Questionnaire Score | Month 2 | 1.08 score on a scale | Standard Deviation 1.31 |
| BREATHE-Peds Intervention | Mean Asthma Impairment and Risk Questionnaire Score | Month 1 | 1.46 score on a scale | Standard Deviation 1.98 |
| BREATHE-Peds Intervention | Mean Asthma Impairment and Risk Questionnaire Score | Month 3 | 1.75 score on a scale | Standard Deviation 1.71 |
| Control Intervention | Mean Asthma Impairment and Risk Questionnaire Score | Month 1 | 1.64 score on a scale | Standard Deviation 2.46 |
| Control Intervention | Mean Asthma Impairment and Risk Questionnaire Score | Month 3 | 1.82 score on a scale | Standard Deviation 1.94 |
| Control Intervention | Mean Asthma Impairment and Risk Questionnaire Score | Baseline | 3.00 score on a scale | Standard Deviation 2.1 |
| Control Intervention | Mean Asthma Impairment and Risk Questionnaire Score | Month 2 | 1.45 score on a scale | Standard Deviation 2.21 |
Secondary
Mean Asthma Quality of Life Questionnaire Score
Asthma quality of life improvements as measured by the Asthma Quality of Life Questionnaire (AQLQ), a 32-item validated and widely-used measure consisting of 4 domains: symptoms (11 items), emotions (5 items), environment (4 items), and activities (12 items). Each item is measured on a 7-point Likert scale (7 = not impaired at all, 1 = severely impaired). The overall AQLQ score is the mean of all 32 responses and the individual domain scores are the means of the items in those domains. The overall score ranges from 1 to 7, where lower mean scores indicate lower quality of life due to asthma (worse outcome).
Time frame: Up to 3 months post intervention
Population: Pediatric patient participants only
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BREATHE-Peds Intervention | Mean Asthma Quality of Life Questionnaire Score | Month 1 | 5.78 score on a scale | Standard Deviation 1.24 |
| BREATHE-Peds Intervention | Mean Asthma Quality of Life Questionnaire Score | Baseline | 5.37 score on a scale | Standard Deviation 1.32 |
| BREATHE-Peds Intervention | Mean Asthma Quality of Life Questionnaire Score | Month 3 | 5.89 score on a scale | Standard Deviation 1.19 |
| Control Intervention | Mean Asthma Quality of Life Questionnaire Score | Baseline | 5.72 score on a scale | Standard Deviation 1.05 |
| Control Intervention | Mean Asthma Quality of Life Questionnaire Score | Month 1 | 6.44 score on a scale | Standard Deviation 0.8 |
| Control Intervention | Mean Asthma Quality of Life Questionnaire Score | Month 3 | 6.17 score on a scale | Standard Deviation 1.21 |
Secondary
Mean Medication Adherence Report Scale - Asthma Score
Inhaled corticosteroid adherence as measured by the Medication Adherence Report Scale - Asthma (MARS-A). Participants are asked to rate the frequency with which they engage in each of the adherence-related behaviors on a five-point scale, where 5 = never, 4 = rarely, 3 = sometimes, 2 = often and 1 = always. Scores for each item are summed to give a total score ranging from 1 to 5, with higher scores indicating higher levels of reported adherence.
Time frame: Up to 3 months post intervention
Population: Pediatric patient participants who were prescribed ICS at baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BREATHE-Peds Intervention | Mean Medication Adherence Report Scale - Asthma Score | Baseline | 4.13 score on a scale | Standard Deviation 0.81 |
| BREATHE-Peds Intervention | Mean Medication Adherence Report Scale - Asthma Score | Month 1 | 4.13 score on a scale | Standard Deviation 0.88 |
| BREATHE-Peds Intervention | Mean Medication Adherence Report Scale - Asthma Score | Month 2 | 4.34 score on a scale | Standard Deviation 0.68 |
| BREATHE-Peds Intervention | Mean Medication Adherence Report Scale - Asthma Score | Month 3 | 4.45 score on a scale | Standard Deviation 0.683 |
| Control Intervention | Mean Medication Adherence Report Scale - Asthma Score | Month 3 | 4.48 score on a scale | Standard Deviation 0.73 |
| Control Intervention | Mean Medication Adherence Report Scale - Asthma Score | Baseline | 3.87 score on a scale | Standard Deviation 0.8 |
| Control Intervention | Mean Medication Adherence Report Scale - Asthma Score | Month 2 | 4.26 score on a scale | Standard Deviation 0.87 |
| Control Intervention | Mean Medication Adherence Report Scale - Asthma Score | Month 1 | 4.05 score on a scale | Standard Deviation 0.77 |
Secondary
Mean Shared Decision Making-Questionnaire-9 Score
The Shared Decision Making (SDM) Questionnaire-9, is a patient reported, 9-item validated instrument that consists of nine statements that measure the decisional process in medical visits from both patients' and physicians' perspectives. Each statement is rated on a six-point scale from completely disagree (0) to completely agree (5). The raw total score of all items range from 0-45. Lower scores indicate lower levels of shared decision making between provider and patient (in this study as it pertains to asthma treatment) and higher scores indicate higher levels of shared decision making (better outcome).
Time frame: Baseline (immediately post-intervention)
Population: Pediatric patient participants only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BREATHE-Peds Intervention | Mean Shared Decision Making-Questionnaire-9 Score | 42.9 score on a scale | Standard Deviation 8.1 |
| Control Intervention | Mean Shared Decision Making-Questionnaire-9 Score | 39.55 score on a scale | Standard Deviation 8.89 |