AdheRence to Inhaled Corticosteroids in Asthma

Not Applicable

Completed

• Conditions: Asthma; Medication Adherence
• Interventions: Behavioral: ARICA

• Registration Number: NCT03769519
• Lead Sponsor: Duke University

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.

Detailed Description

The investigators will evaluate ARICA in Duke primary care clinics to study its feasibility and acceptability using a quasi-experimental pre-post study design. The study will enroll between 32 and 48 adult African Americans with persistent asthma and suboptimal ICS adherence, and their health care providers, to study the use of the intervention and key indicators of the intervention's potential effectiveness.

Study Timeline

• Study First Submitted: 2018-10-16
• Study First Submitted QC: 2018-12-06
• Study First Posted: 2018-12-07
• Study Start: 2020-02-27
• Primary Completion: 2020-08-19
• Study Completion: 2020-08-19
• Results First Submitted: 2021-08-11
• Status Verified: 2021-11
• Results First Submitted QC: 2021-11-18
• Last Update Submitted: 2021-11-18
• Results First Posted: 2021-12-17
• Last Update Posted: 2021-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Not provided

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Exclusion Criteria

• Unable or unwilling to provide informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARICA Intervention (Group 2)	ARICA	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Reported Experiences With the ARICA Program	3 months	Assessment of participants experiences with and perceptions of the ARICA program, as assessed by in-depth semi-structured qualitative interview.

Secondary Outcome Measures

Name	Time	Method
Change in Patient Reported Medication Adherence as Measured by the DOSE-Nonadherence (Voils) Questionnaire	3 months	patients' medication adherence rates based on Voils adherence questionnaire adherence questionnaire. Difference from baseline to follow up. Scored 0-4, higher is more non-adherent
Change in Asthma Control as Measured by the Asthma Control Test	3 months	patient reported difference from baseline to follow up. Higher score is better asthma control. Range 5-25.
Change in Asthma-Related Quality of Life as Measured by the Marks Asthma-Related Quality of Life Questionnaire	3 months	Patient reported. Difference from baseline to follow up. Range 0-80, higher score means greater impact of asthma on quality of life.

Trial Locations

Locations (1)

Duke Un.; 🇺🇸 Durham, North Carolina, United States