Clinical trial NCT03883594: Technology-Assisted Stepped Care Study
Official title: Technology Assisted Stepped Care (TASC): Phase 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 40
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. This is the third phase (Phase 3) of a three-phase project to test the preliminary efficacy of a technology-assisted stepped care (TASC) intervention. In Phase 1, we developed the intervention using patient and provider feedback from focus groups. In Phase 2 we refined the developed intervention by having five adolescents from the focus groups test the intervention for feasibility. In this third phase, we will enroll up to 50 adolescents to pilot-test the refined intervention for preliminary efficacy.

Detailed description: Up to fifty adolescents with asthma will be enrolled in an open label pilot trial of the TASC adherence-promotion intervention for a duration of twelve 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 cellphone 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. Participants will remain in the study for an additional 7 months after they complete month 5 of the study. For the remaining 7 months, participants will be randomized to one of two booster session patterns with the goal to improve inhaler adherence. The statistician will make the randomization schedule and the principle investigator will maintain the randomization schedule. Two different booster patterns are being used to test which pattern will be most effective. The first booster session pattern will include booster sessions at the end of month 6, 8, and 12. The second booster session pattern will include booster sessions at the end of month 6, 7, 8, 10, and 12. Booster sessions will review content provided during the intervention and the intervention delivery method will be consistent with the participants final intervention step. Participants will also continue to complete monthly check-ins with the study coordinator to complete the Composite Asthma Severity Index, the Asthma Control Test, and a spirometry test.

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)
* Patient receives school administered daily controller medication at the time of the enrollment visit

Primary outcomes:
measure: Electronic Monitoring
timeFrame: 12 months
Secondary outcomes:
measure: Lung Function Assessment
timeFrame: Baseline assessment and then once a month for 12 months
measure: Composite Asthma Severity Index (CASI)
timeFrame: Baseline assessment and then once a month for 12 months
measure: Asthma Control Test (ACT)
timeFrame: Baseline assessment and then once a month for 12 months
measure: Attendance/Participation rates
timeFrame: 12 months
measure: Feasibility/Acceptability Questionnaire
timeFrame: 5 months
measure: System Usability Scale
timeFrame: 5 months
measure: Acceptability of Intervention Measure (AIM)
timeFrame: At 5 months
measure: Intervention Appropriateness Measure (IAM)
timeFrame: At 5 months
measure: Feasibility of Intervention Measure (FIM)
timeFrame: At 5 months
measure: Treatment Fidelity
timeFrame: 12 months
measure: Time Needed for Intervention
timeFrame: 12 months
measure: Perceived Characteristics of Intervention Scale
timeFrame: At 12 months
Other outcomes:
measure: Behavior Assessment System for Children-Third Edition, Self-report of Personality (BASC-3-SRP-A
timeFrame: Baseline assessment and at 5 months
measure: Adolescent Barriers to Medication Scales (AMBS)
timeFrame: Baseline Assessment
measure: Technology-based Experience of Need Satisfaction- Interface questionnaire (TENS-Interface)
timeFrame: Baseline assessment and then at 2 months
measure: Autonomy and Competence in Technology Adoption Questionnaire (ACTA)
timeFrame: Baseline Assessment
measure: Technology-based Experience of Need Satisfaction- Task questionnaire (TENS- Task)
timeFrame: Baseline assessment and then at 2 months
measure: Technology Effects on Need Satisfaction in Life (TENS- Life)
timeFrame: Baseline assessment and then at 2 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:
References: