Technology-Assisted Stepped Care Study

NCT03883594 | Completed

• 1 other identifier: CIN001- {"TASC Phase 3"}
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (12)

• Lung Function Assessment

  Baseline assessment and then once a month for 12 months

• Composite Asthma Severity Index (CASI)

  Baseline assessment and then once a month for 12 months

• Asthma Control Test (ACT)

  Baseline assessment and then once a month for 12 months

• Attendance/Participation rates

  12 months

• Feasibility/Acceptability Questionnaire

  5 months

Other Outcomes (8)

• Behavior Assessment System for Children-Third Edition, Self-report of Personality (BASC-3-SRP-A

  Baseline assessment and at 5 months

• Adolescent Barriers to Medication Scales (AMBS)

  Baseline Assessment

• Technology-based Experience of Need Satisfaction- Interface questionnaire (TENS-Interface)

  Baseline assessment and then at 2 months

Study Arms (1)

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.

Behavioral: Technology-assisted Stepped-care

Interventions

Technology-assisted Stepped-care BEHAVIORAL

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.

TASC Intervention

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Medical Hospital

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: March 21, 2019
• Study Start: December 7, 2018
• Primary Completion: April 20, 2021
• Study Completion: April 20, 2021
• Last Updated: March 10, 2022

Record last verified: 2022-03

Locations

US (1)