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Technology-Assisted Stepped Care Study (TASC Phase 3)

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ClinicalTrials.gov Identifier: NCT03883594
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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.

Condition or disease Intervention/treatment Phase
Asthma Behavioral: Technology-assisted Stepped-care Not Applicable

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Technology Assisted Stepped Care (TASC): Phase 3
Actual Study Start Date : December 7, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: TASC Intervention
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.
Behavioral: Technology-assisted Stepped-care
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Lung Function Assessment [ Time Frame: Baseline assessment and then once a month for 5 months ]
    The mobile spirometer records multiple parameters of the patient's lung function including forced expiratory volume, peak expiratory flow, forced vital capacity, and forced expiratory flow. The spirometer sends the values to the corresponding mobile phone application, Propeller Health, which is directly accessible to the patient.

  2. Composite Asthma Severity Index (CASI) [ Time Frame: Baseline assessment and then once a month for 5 months ]
    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.

  3. Asthma Control Test (ACT) [ Time Frame: Baseline assessment and then once a month for 5 months ]
    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.

  4. Attendance/Participation rates [ Time Frame: 5 months ]
    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.

  5. Feasibility/Acceptability Questionnaire [ Time Frame: 5 months ]
    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.

  6. System Usability Scale [ Time Frame: 5 months ]
    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.

  7. Acceptability of Intervention Measure (AIM) [ Time Frame: At 5 months ]
    A 4 item measure of participants' belief that the intervention is acceptable will be given at the end of the study. Participants respond to each statement on a 5 point Likert scale (1= Completely Disagree, 5= Completely Agree).

  8. Intervention Appropriateness Measure (IAM) [ Time Frame: At 5 months ]
    A 4 item measure of participants' perception that the intervention is appropriate will be given at the end of the study. Participants respond to each statement on a 5 point Likert scale (1= Completely Disagree, 5= Completely Agree).

  9. Feasibility of Intervention Measure (FIM) [ Time Frame: At 5 months ]
    A 4 item measure of participants' belief that the intervention is feasible will be given at the end of the study. Participants respond to each statement on a 5 point Likert scale (1= Completely Disagree, 5= Completely Agree).

  10. Treatment Fidelity [ Time Frame: 5 months ]
    Treatment fidelity needed for the intervention will be assessed. Treatment fidelity will be assessed through fidelity checklists created specifically for each intervention session.

  11. Time Needed for Intervention [ Time Frame: 5 months ]
    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.


Other Outcome Measures:
  1. Behavior Assessment System for Children-Third Edition, Self-report of Personality (BASC-3-SRP-A [ Time Frame: Baseline assessment and at 5 months ]
    The BASC-3 is a widely used, reliable (α= 0.94 - 0.96 , test-retest r= 0.81 -0.82), and valid inventory to assess emotional and behavioral symptoms in adolescents and young adults (ages 13-21).

  2. Adolescent Barriers to Medication Scales (AMBS) [ Time Frame: Baseline Assessment ]
    The AMBS is an 18-item validated measure of perceived barriers to medication adherence in adolescents.

  3. Technology-based Experience of Need Satisfaction- Interface questionnaire (TENS-Interface) [ Time Frame: Baseline assessment and then at 2 months ]
    A 15- item measure of participant's competence, autonomy, and relatedness in using technology. Participants rate their level of agreement to each statement on a 5- point Likert scale (1= Do Not Agree, 5= Strongly Agree).

  4. Autonomy and Competence in Technology Adoption Questionnaire (ACTA) [ Time Frame: Baseline Assessment ]
    A 10-item measure of why people adopt use of a technology (i.e. download an app, register with a website, purchase a wearable device, etc.).Participants respond to self-regulation statements on a scale of 1 to 5, 1 being 'not at all true' and 5 being 'very true.'

  5. Technology-based Experience of Need Satisfaction- Task questionnaire (TENS- Task) [ Time Frame: Baseline assessment and then at 2 months ]
    An 8-item measure of participant's competence, autonomy, and relatedness in managing their asthma using technology. Participants rate their level of agreement to each statement on a 5- point Likert scale (1= Do Not Agree, 5= Strongly Agree).

  6. Technology Effects on Need Satisfaction in Life (TENS- Life) [ Time Frame: Baseline assessment and then at 2 months ]
    The TENS-Life is a 10- item measure of the extent to which a user perceives that the use of a particular technology has had an influence on the satisfaction of basic psychological needs in their life. Participants rate their level of agreement to each statement on a 5- point Likert scale (1= Do Not Agree, 5= Strongly Agree).

  7. Knowledge Questionnaire [ Time Frame: Baseline Assessment ]
    A 13-item questionnaire assessing individual's knowledge of asthma symptoms, triggers, and medications. Participants rate their level of agreement to each statement on a scale from 'Strongly Agree' to 'Strongly Disagree.' This questionnaire will be completed at the baseline visit.

  8. Hardship Questionnaire [ Time Frame: Baseline Assessment ]
    A 19-item validated questionnaire assessing the financial strain of individuals within a household.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03883594


Locations
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United States, Ohio
Cincinnati Children's Medical Hospital Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Sophie R Kollin, BA    513-636-8254    sophie.kollin@cchmc.org   
Contact: Rachelle R Ramsey, PhD    513-803-8348    rachelle.ramsey@cchmc.org   
Principal Investigator: Rachelle R Ramsey, PhD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03883594     History of Changes
Other Study ID Numbers: CIN001- {"TASC Phase 3"}
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No