AdheRence to Inhaled Corticosteroids in Asthma

Asthma Clinical Trial

— ARICA  

Official title:

AdheRence to Inhaled Corticosteroids in Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03769519
• Other study ID #: Pro00100181
• Status: Completed
• Phase: N/A
• Start date: February 27, 2020
• Est. completion date: August 19, 2020

Study information

• Verified date: November 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: August 19, 2020
• Est. primary completion date: August 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Medication Adherence

Intervention

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

Locations

Country	Name	City	State
United States	Duke Un.	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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