Using Technology-Assisted Stepped Care Intervention to Improve Adherence in Adolescents With Asthma

NCT04365556 | Completed Results DMC

• 2 other identifiers: CIN001- {"Asthma Ctrl"}K23HL139992
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

To test the preliminary efficacy of the TASC adherence promotion intervention for adolescents with asthma in a feasibility randomized controlled trial compared to treatment as usual control arm.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Percent Change in Inhaler Adherence Via Electronic Monitoring

  The electronic monitoring system records every dose, or "puff", the patient takes and sends it to a corresponding online database that is accessible to study staff. 30 day adherence is calculated by doses taken divided by doses prescribed and is capped at 100%. Percent Change refers to the change in percent adherence at baseline compared to end of study.

  30 days

Secondary Outcomes (3)

• Change in Composite Asthma Severity Index

  2 months

• Feasibility Questionnaire

  6 months

• Usability: Questionnaire

  6 months

Study Arms (2)

TASC Intervention

EXPERIMENTAL

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.

Behavioral: TASC Intervention

Treatment as Usual

NO INTERVENTION

Participants will not receive any intervention.

Interventions

TASC Intervention BEHAVIORAL

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.

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, pulmonary hypertension, and moderate or severe tracheomalacia)
• Patient receives school administered daily controller medication at the time of the enrollment visit

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

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

Results Point of Contact

• Title: Rachelle Ramsey
• Organization: Cincinnati Children's Hospital Medical Center

rachelle.ramsey@cchmc.org

513-803-0415

Study Officials

• Rachelle R Ramsey, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial comparing the TASC Intervention to a treatment as usual control arm.

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 28, 2020
• Study Start: November 19, 2019
• Primary Completion: May 24, 2024
• Study Completion: July 2, 2024
• Last Updated: September 18, 2025
• Results First Posted: September 18, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)