AdheRence to Inhaled Corticosteroids in Asthma

Study Overview
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Brief Summary
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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
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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.

Official Title
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AdheRence to Inhaled Corticosteroids in Asthma

Conditions
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Medication Adherence, Asthma

Intervention / Treatment
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* Behavioral: ARICA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 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 Exclusion Criteria: Unable or unwilling to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control (Group 1)<br>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. | |
| Experimental: ARICA Intervention (Group 2)<br>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<br>* Personalized ARICA (AdheRence to Inhaled Corticosteroids in Asthma) intervention package.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Reported Medication Adherence as Measured by the DOSE-Nonadherence (Voils) Questionnaire | 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 | 3 months | 
| Change in Asthma Control as Measured by the Asthma Control Test | patient reported difference from baseline to follow up. Higher score is better asthma control. Range 5-25. | 3 months | 
| Change in Asthma-Related Quality of Life as Measured by the Marks Asthma-Related Quality of Life Questionnaire | Patient reported. Difference from baseline to follow up. Range 0-80, higher score means greater impact of asthma on quality of life. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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health disparities, african american, adult