Clinical trial NCT03733457: Technology- Assisted Stepped Care Intervention Study
Official title: Technology-Assisted Stepped Care Intervention Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2018-11-07
Enrollment: 16
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The overall goal of this project is to demonstrate the feasibility, implementation, and preliminary efficacy of a technology-assisted stepped care (TASC) adherence-promotion intervention in adolescents with asthma. Preliminary efficacy will be demonstrated by improved adherence to daily inhaled corticosteroids as measured by Propeller Health electronic monitoring devices. The TASC intervention will result in improved disease severity measured by the Composite Asthma Severity Index (combining dose of asthma medication required, asthma symptom burden, and frequency of exacerbations and health care utilization) and lung function as measured by mobile spirometry. The TASC adherence-promotion intervention implementation will be successful as evidenced by high levels of feasibility (e.g., attendance), acceptability (20 item Acceptability Questionnaire), and usability (10 item Usability Scale).

Detailed description: Up to thirty adolescents with asthma will be enrolled in an open label pilot trial of the TASC adherence-promotion intervention for a duration of five months. First, participants will complete baseline questionnaires related to demographic, and clinical predictors of adherence and asthma and a 4 week run-in phase to assess baseline adherence using electronic inhaler monitoring with a cellphone that is provided to them. Following the run-in period, all participants will receive Step 1 of the TASC intervention for a minimum of 4 weeks. 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. Following the initial four weeks of Step 1, adherence will be evaluated and a rate of less than 68% will serve as the cause for "stepping up" to the next level of the intervention. Adherence checks will continue to occur every four weeks for the duration of the study and adherence \<68% will prompt movement from one level of treatment to the next. 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. 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. The primary outcome measure will be electronically-monitored adherence assessed at post-treatment. Secondary outcomes include asthma severity as well as process evaluation questions and quantitative measures of feasibility, acceptability, and satisfaction to demonstrate implementation.

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

Primary outcomes:
measure: Electronic Monitoring
timeFrame: 5 Months
Secondary outcomes:
measure: Composite Asthma Severity Index (CASI)
timeFrame: Baseline assessment and then once a month for 5 months
measure: Asthma Control Test (ACT)
timeFrame: Baseline assessment and then once a month for 5 months
measure: Attendance/Participation rates
timeFrame: 5 months
measure: Feasibility/Acceptability Questionnaire
timeFrame: 5 months
measure: System Usability Scale
timeFrame: 5 months
measure: Treatment Fidelity
timeFrame: 5 months
measure: Time Needed for Intervention
timeFrame: 5 months
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Medical Hospital
state: Ohio
Study officials:
References: