AsthmaTASCNCT03733457
Technology- Assisted Stepped Care Intervention Study
A study testing Technology-assisted Stepped-care in people with Asthma, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Asthma
- What is being tested?
- Technology-assisted Stepped-care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2017to 19 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Medical Hospital
Cincinnati, Ohio, 45229
About this study
Official title: Technology-Assisted Stepped Care Intervention Pilot Study
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).
Read the 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.
- Conditions
- Asthma
- Being tested
- Technology-assisted Stepped-care
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-assisted Stepped-careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| TASC Intervention | Experimental | 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. Receives: Behavioral: Technology-assisted Stepped-care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electronic Monitoring
The Propeller Health 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.
Measured: 5 Months
Secondary outcomes (7)
Composite Asthma Severity Index (CASI)
The participants' composite asthma severity index score will be calculated through the TreatSmart program. TreatSmart will be used to determine the participant's symptom burden, health care utilization, systemic corticosteroid use, and current medication use to determine the level of asthma severity/control the participant has. The program also makes an initial treatment recommendation based on the National Asthma Education and Prevention Program (NAEPP asthma guidelines). Individuals are placed in Step 1 through Step 6 depending on the strength and frequency of their inhaled corticosteroid (1 being low dose and 6 being a high dose). In addition, individuals are categorized as very poorly controlled, not well controlled, or well controlled based on how frequently they have had asthma symptoms or used their rescue inhaler, gone to the hospital or urgent care, or received steroids for asthma symptoms.
Measured: Baseline assessment and then once a month for 5 months
Asthma Control Test (ACT)
The ACT will be used as a measure of disease severity in this study. The ACT is a 5-question scoring tool designed for patients with asthma who are 12 years and older. The questions ask the patient to rate their asthma severity, symptom frequency, control, and inhaler use on a scale of 1-5. The total score is calculated by the sum of each response, which determines how well-controlled the patient's asthma is on a scale from 5-25.
Measured: Baseline assessment and then once a month for 5 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 and/or Propeller Health app), 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.
Measured: 5 months
Feasibility/Acceptability Questionnaire
A 5-31 item 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.
Measured: 5 months
System Usability Scale
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.
Measured: 5 months
Treatment Fidelity
Treatment fidelity needed for the intervention will be assessed. Treatment fidelity will be assessed through fidelity checklists created specifically for each intervention session.
Measured: 5 months
Time Needed for Intervention
Sessions will be timed and the number of weeks to complete the session will be tracked to determine the average length of time needed for the intervention.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start7 Nov 2017
- Primary completion19 Jun 2019
- Study completion19 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733457
- Sponsor's protocol ID
- CIN001- {"TASC Intervention"}
- Acronym
- TASC
- Status last verified
- Feb 2021
- First submitted
- 30 Oct 2018
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-Assisted Stepped Care Intervention Pilot Study
- ClinicalTrials.gov ID
- NCT03733457
- Acronym / sponsor ID
- TASC / CIN001- {"TASC Intervention"}
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 19 Jun 2019 (actual)
- Study completion
- 19 Jun 2019 (actual)
- First posted
- 7 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TASC Intervention | Experimental | Behavioral: Technology-assisted Stepped-careAll 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology-assisted Stepped-careStep 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. | Behavioural | TASC Intervention |
Primary outcome
Electronic Monitoring
Time frame: 5 Months
The Propeller Health 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.
7 secondary outcomes
Composite Asthma Severity Index (CASI)
Time frame: Baseline assessment and then once a month for 5 months
Asthma Control Test (ACT)
Time frame: Baseline assessment and then once a month for 5 months
Attendance/Participation rates
Time frame: 5 months
Feasibility/Acceptability Questionnaire
Time frame: 5 months
System Usability Scale
Time frame: 5 months
Treatment Fidelity
Time frame: 5 months
Time Needed for Intervention
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-assisted Stepped-care in people with Asthma, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electronic Monitoring (time frame: 5 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.