AdheRence to Inhaled Corticosteroids in Asthma

NCT03769519 | Completed Results

• 1 other identifier: Pro00100181
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

It is widely recognized that asthma in adult African American patients is a significant health problem, which is partly affected by relatively low inhaled corticosteroid (ICS) adherence rates. The goal of this study is to pilot test an ICS adherence intervention, ARICA, that aims to improve ICS adherence in adult African Americans.

Conditions

Medication Adherence; Asthma

Keywords

health disparities; african american; adult

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Reported Experiences With the ARICA Program

  Assessment of participants experiences with and perceptions of the ARICA program, as assessed by in-depth semi-structured qualitative interview.

  3 months

Secondary Outcomes (3)

• Change in Patient Reported Medication Adherence as Measured by the DOSE-Nonadherence (Voils) Questionnaire

  3 months

• Change in Asthma Control as Measured by the Asthma Control Test

  3 months

• Change in Asthma-Related Quality of Life as Measured by the Marks Asthma-Related Quality of Life Questionnaire

  3 months

Study Arms (2)

Control (Group 1)

NO INTERVENTION

This group is considered the control group. This group will have scheduled texts and emails for the monthly surveys after the participant completes the baseline questionnaires.

ARICA Intervention (Group 2)

EXPERIMENTAL

This group is considered the intervention group. Participants in this group will receive weekly texts and emails containing asthma facts and myths. They will also complete monthly surveys and participate in asthma education sessions.

Behavioral: ARICA

Interventions

ARICA BEHAVIORAL

Personalized ARICA (AdheRence to Inhaled Corticosteroids in Asthma) intervention package.

ARICA Intervention (Group 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Self-identifying African American
• Self-reported current asthma
• Prescribed an inhaled corticosteroid (alone or combination) for ≥ 1 month
• Presented at a Duke Primary Care clinic visit within the past 3 years or is establishing care at Duke Primary Care
• Follow up Duke Primary Care visit within the next 6 months

You may not qualify if:

• Unable or unwilling to provide informed consent

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Un.

Durham, North Carolina, 27701, United States

Location

MeSH Terms

Conditions

Medication Adherence; Asthma

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Isaretta L. Riley, MD, MPH
• Organization: Duke

isaretta.riley@duke.edu

919-286-0411

Study Officials

• Isaretta L Riley, MD

  Duke Un.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: December 7, 2018
• Study Start: February 27, 2020
• Primary Completion: August 19, 2020
• Study Completion: August 19, 2020
• Last Updated: December 17, 2021
• Results First Posted: December 17, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)