Using Technology-Assisted Stepped Care Intervention to Improve Adherence in Adolescents With Asthma

Study Overview
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Brief Summary
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To test the preliminary efficacy of the TASC adherence promotion intervention for adolescents with asthma in a feasibility randomized controlled trial compared to treatment as usual control arm.

Detailed Description
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The current study involving human subjects consists of a Randomized Controlled Trial to test the feasibility, effectiveness, and implementation of the TASC intervention as compared to a treatment as usual group. A total of up to 70 adolescents with moderate or severe persistent asthma between the ages of 12-18 years will be randomized to TASC (n=35) or treatment as usual (n = 35). After adolescent participants have met inclusion criteria, completed baseline assessments, and have been enrolled in the feasibility RCT, they will be randomized to either TASC or Treatment As Usual (TAU). Outcomes measures (adherence and disease severity) will be assessed at baseline, monthly during active treatment, and at post-treatment, with the primary endpoint being post-treatment. Participants will be enrolled in the study for a duration of six months. The TASC intervention will be delivered using technology so that participants do not need any resources to travel to appointments. Step 1 (Information) will include electronic educational information related to asthma symptoms and triggers, attacks, self-monitoring, treatments, action plans, and automated text message medication reminders. Step 1 will be provided to all adolescents. Adherence will be electronically monitored, but feedback will not be provided. Step 2 (Motivation) will include electronic monitoring of adherence and personally tailored feedback via text messages. Adolescents will be given access to the adherence tracking smartphone app and graphs of their inhaler adherence. Adolescents will also receive brief, personalized text messages that provide supportive motivation and directive, tangible actions. Step 3 (Behavioral) will include problem-solving telehealth intervention with a trained clinician. Four telehealth sessions individually tailored to the unique needs and barriers of the adolescent will be provided. These will be based on a functional analysis via objective adherence data, graphical feedback, and discussion of adherence patterns allowing for a comprehensive understanding of specific behavioral factors interfering with adherence. Behavioral treatment plans will be modified based on a patient's progress in treatmentand ability to achieve short-term adherence goals. Patients will also be contacted via text messaging to assess success with specific adherence plans between sessions based on objective data. This telehealth intervention will be delivered to adolescents' cell phones via video conferencing software. All participants will complete baseline questionnaires related to demographic, and clinical predictors of adherence and asthma. They will be randomized following completion of baseline measures. Inhaler adherence caps will also be provided to all participants and utilized for 2 months without feedback to obtain baseline adherence. In addition, all participants receive a mobile spirometer to track their lung function throughout the study. The spirometer connects to an app via Bluetooth. This app allows the participant to perform pulmonary function tests (PFTs) and view the results of these tests, such as their forced expiratory volume (FEV1) as well as other lung function parameters. All participants will be asked to use the spirometer at least once a month when completing study visits over the phone with a study team member. Following the baseline visit, an 8 week run-in phase will be completed to assess baseline adherence using electronic inhaler monitoring. After obtaining 4 weeks of adherence data, the coordinator will call the participants in TASC and TAU for their first monthly phone call. After an additional 4 weeks of adherence data, the coordinator will call the participants in the TASC and TAU for their second monthly phone call. The coordinator will calculate baseline adherence and obtain data for asthma severity and asthma control for TASC and TAU participants. For TASC participants only, the coordinator will introduce Step 1 of the intervention for all participants. Adherence checks will continue to occur every four weeks for the duration of the study for all participants and adherence <68% will prompt movement from one level of treatment to the next for TASC participants only. The study coordinator will calculate TASC participant's adherence percentage prior to the monthly telephone call. During the call, the coordinator will tell the participant if they will get moved up to the next step and explain what they will be doing during that step. TASC participants may remain at a treatment level for more than four weeks and may complete 1, 2, or 3 interventions steps during the 5 month study depending on the adolescent's adherence. Brief measures will be completed by all participants online via REDCap. Participant specific data such as asthma severity, lung function, and adherence will be collected through the mobile phone application and via telephone. Clinical chart reviews will be conducted by study staff to provide an accurate estimate of lung function and disease severity from the date of consent to the end of study date.

Official Title
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Using Technology-Assisted Stepped Care Intervention to Improve Adherence in Adolescents With Asthma

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: TASC Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient age between 12-18 years Patient is diagnosed with severe-persistent or moderate-persistent asthma per NAEPP asthma guidelines Patient is prescribed at least one daily inhaled controller medication or a daily combination inhaled corticosteroid and long-acting beta-agonist and a beta-agonist bronchodilator English fluency for patient, caregiver, and clinician Exclusion Criteria: Significant cognitive deficits that may interfere with comprehension per medical team or chart review Diagnosis of serious mental illness (e.g., schizophrenia) Diagnosis of pervasive developmental disorder Active chronic disease apart from asthma or allergic disease (e.g. Bronchiectasis, pulmonary hypertension, and moderate or severe tracheomalacia) Patient receives school administered daily controller medication at the time of the enrollment visit

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial comparing the TASC Intervention to a treatment as usual control arm.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TASC Intervention<br>Step 1 of the intervention includes educational materials related to asthma. Step 2 includes electronic monitoring of adherence and a text messaging intervention personally tailored to the participant. Step 3 includes problem solving telehealth sessions with a trained clinician. | Behavioral: TASC Intervention<br>* All participants receive Step 1 of the intervention. Participants who have adherence below or at 68% will step up to Step 2 or Step 3 after the third or fourth month in the study.<br>|
| No Intervention: Treatment as Usual<br>Participants will not receive any intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inhaler Adherence Electronic Monitoring | The electronic monitoring system includes a Bluetooth enabled sensor that attaches to the patient's inhaler. This sensor records every dose, or puff, the patient takes and sends it to a corresponding online database that is accessible to study staff. Participants will be given this sensor at baseline. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced Expiratory Volume (FEV1) | The mobile spirometer records forced expiratory volume measured in liters. The spirometer sends the values to the corresponding mobile phone application, which is directly accessible to the patient. | Time Frame: Baseline assessment and then once a month for 6 months | 
| Peak Expiratory Flow (PEF) | The mobile spirometer records peak expiratory flow measured in liters per minute. The spirometer sends the values to the corresponding mobile phone application, which is directly accessible to the patient. | Time Frame: Baseline assessment and then once a month for 6 months | 
| Forced Vital Capacity (FVC) | The mobile spirometer records forced vital capacity measured in liters. The spirometer sends the values to the corresponding mobile phone application, which is directly accessible to the patient. | Time Frame: Baseline assessment and then once a onth for 6 months | 
| Forced Expiratory Flow (FEF) | The mobile spirometer records forced expiratory flow measured in liters. The spirometer sends the values to the corresponding mobile phone application, which is directly accessible to the patient. | Time Frame: Baseline assessment and then once a month for 6 months | 
| Asthma Severity Score via TreatSmart | TreatSmart is used to determine the participant's symptom burden, health care utilization, systemic corticosteroid use, and current medication use over the past month to determine the level of asthma severity/control the participant has. | Baseline assessment and then once a month for 6 months | 
| Asthma Control Test (ACT) | This measure asks the patient to rate their asthma severity, symptom frequency, control, and inhaler use on a scale of 1 to 5 for each question. The total scale is 5 to 25, with 5 meaning poorly controlled asthma and 25 meaning well controlled asthma. | Baseline assessment and then once a month for 6 months | 
| Attendance/Participation rates | Participation rates will be measured 3 different ways. The first measure will be how often participants accessed the electronic material (educational materials), the second measure will be how many responses to directive text messaging were received, and the third measure will be attendance to the telehealth sessions. | 6 months | 
| Feasibility/Acceptability Questionnaire | A measure of format, content, length, skills and acceptability of the intervention will be given to participants in the form of a questionnaire at the end of each step and the end of the study. The feasibility section is on a scale of 0 to 4, 0 being the worst and 4 being the best. The acceptability questionnaire is on a scale from 'Not at all' to 'Very,' 'Not at all' being the worst and 'Very' being the best. | 6 months | 
| Usability: questionnaire | A 10 item, Likert scale giving a global view of usability will be given to participants in the form of a questionnaire at the end of each step and at the end of the study. The scale ranges from 'Strongly Disagree' to 'Strongly Agree, with half of the items reverse scored. | 6 months | 
| Intervention Acceptability: questionnaire | A 4 item measure of participants' belief that the intervention is acceptable will be given at the end of the study. Participants respond to each statement on a 5 point Likert scale (1= Completely Disagree, 5= Completely Agree). | At 5 months | 
| Intervention Appropriateness | A 4 item measure of participants' perception that the intervention is appropriate will be given at the end of the study. Participants respond to each statement on a 5 point Likert scale (1= Completely Disagree, 5= Completely Agree). | At 6 months | 
| Intervention Feasibility: questionnaire | A 4 item measure of participants' belief that the intervention is feasible will be given at the end of the study. Participants respond to each statement on a 5 point Likert scale (1= Completely Disagree, 5= Completely Agree). | At 6 months | 
| Treatment Fidelity via Fidelity Checks | Treatment fidelity needed for the intervention will be assessed. Treatment fidelity will be assessed through fidelity checklists created specifically for each intervention session based on the intervention manual. | 6 months | 
| Time Needed for Intervention | Sessions will be timed to determine the average length of time needed for the intervention. | 6 months | 
| Weeks Needed for Intervention | The number of weeks to complete the session will be tracked to determine the average length of time needed for the intervention. | 6 months | 
| Perceived Characteristics of Intervention Scale (PCIS) | 19 item measure of interventionist's views toward the study intervention on a 5 point likert scale, with higher scores indicating better perception of the intervention. | 6 months |