Technology- Assisted Stepped Care Intervention Study

NCT03733457 | Completed

• 1 other identifier: CIN001- {"TASC Intervention"}
• Study Type: interventional
• Target: 16
• 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. 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).

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.

  5 Months

Secondary Outcomes (7)

• Composite Asthma Severity Index (CASI)

  Baseline assessment and then once a month for 5 months

• Asthma Control Test (ACT)

  Baseline assessment and then once a month for 5 months

• Attendance/Participation rates

  5 months

• Feasibility/Acceptability Questionnaire

  5 months

• System Usability Scale

  5 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

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: October 30, 2018
• First Posted: November 7, 2018
• Study Start: November 7, 2017
• Primary Completion: June 19, 2019
• Study Completion: June 19, 2019
• Last Updated: February 16, 2021

Record last verified: 2021-02

Locations

US (1)