Technology-Assisted Stepped Care Study
Status: | Recruiting |
---|---|
Conditions: | Asthma, Asthma |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 12 - 18 |
Updated: | 3/23/2019 |
Start Date: | December 7, 2018 |
End Date: | December 2021 |
Technology Assisted Stepped Care (TASC): Phase 3
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.
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.
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 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
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.
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
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.
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)
We found this trial at
1
site
Cincinnati, Ohio 45229
Principal Investigator: Rachelle R Ramsey, PhD
Phone: 513-636-8254
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