Clinical trial NCT04365556: Using Technology-Assisted Stepped Care Intervention to Improve Adherence in Adolescents With Asthma
Official title: Using Technology-Assisted Stepped Care Intervention to Improve Adherence in Adolescents With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 76
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial comparing the TASC Intervention to a treatment as usual control arm.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Inhaler Adherence Electronic Monitoring
timeFrame: 6 months
Secondary outcomes:
measure: Forced Expiratory Volume (FEV1)
timeFrame: Time Frame: Baseline assessment and then once a month for 6 months
measure: Peak Expiratory Flow (PEF)
timeFrame: Time Frame: Baseline assessment and then once a month for 6 months
measure: Forced Vital Capacity (FVC)
timeFrame: Time Frame: Baseline assessment and then once a onth for 6 months
measure: Forced Expiratory Flow (FEF)
timeFrame: Time Frame: Baseline assessment and then once a month for 6 months
measure: Asthma Severity Score via TreatSmart
timeFrame: Baseline assessment and then once a month for 6 months
measure: Asthma Control Test (ACT)
timeFrame: Baseline assessment and then once a month for 6 months
measure: Attendance/Participation rates
timeFrame: 6 months
measure: Feasibility/Acceptability Questionnaire
timeFrame: 6 months
measure: Usability: questionnaire
timeFrame: 6 months
measure: Intervention Acceptability: questionnaire
timeFrame: At 5 months
measure: Intervention Appropriateness
timeFrame: At 6 months
measure: Intervention Feasibility: questionnaire
timeFrame: At 6 months
measure: Treatment Fidelity via Fidelity Checks
timeFrame: 6 months
measure: Time Needed for Intervention
timeFrame: 6 months
measure: Weeks Needed for Intervention
timeFrame: 6 months
measure: Perceived Characteristics of Intervention Scale (PCIS)
timeFrame: 6 months
Other outcomes:
measure: Behavioral Assessment (BASC-3)
timeFrame: Baseline assessment and at 6 months
measure: Credibility Expectancy Questionnaire (CEQ)
timeFrame: After 2nd month
measure: Asthma Responsibility Questionnaire (ARQ)
timeFrame: Baseline assessment and at 6 months
measure: Adolescent Medication Barriers Scale (AMBS)
timeFrame: Baseline Assessment and at 6 months
measure: Technology Experience
timeFrame: Baseline assessment and then at 3 months
measure: Technology Autonomy
timeFrame: Baseline Assessment
measure: Technology Satisfaction: questionnaire
timeFrame: Baseline assessment and then at 3 months
measure: Technology Satisfaction in Life: questionnaire
timeFrame: Baseline assessment and then at 3 months
measure: Knowledge Questionnaire
timeFrame: Baseline Assessment
measure: Hardship Questionnaire
timeFrame: Baseline Assessment
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Medical Hospital
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Rachelle R Ramsey, PhD
role: PRINCIPAL_INVESTIGATOR
References: