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AdheRence to Inhaled Corticosteroids in Asthma (ARICA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03769519
Recruitment Status : Completed
First Posted : December 7, 2018
Last Update Posted : September 14, 2020
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Medication Adherence Asthma Behavioral: ARICA Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: AdheRence to Inhaled Corticosteroids in Asthma
Actual Study Start Date : February 27, 2020
Actual Primary Completion Date : August 19, 2020
Actual Study Completion Date : August 19, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids

Arm Intervention/treatment
No Intervention: Control (Group 1)
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)
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
Personalized ARICA (AdheRence to Inhaled Corticosteroids in Asthma) intervention package.

Primary Outcome Measures :
  1. Participant experiences with and perceptions of the ARICA program [ Time Frame: 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 :
  1. Change in patient reported medication adherence as measured by the Voils Adherence Questionnaire [ Time Frame: 3 months ]
    patients' medication adherence rates based on Voils adherence questionnaire adherence questionnaire

  2. Change in Asthma Control as measured by the Asthma Control Test [ Time Frame: 3 months ]
    patient reported

  3. Change in Asthma-Related Quality of Life as measured by the Marks Asthma-Related Quality of Life Questionnaire [ Time Frame: 3 months ]
    patient reported

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03769519

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United States, North Carolina
Duke Un.
Durham, North Carolina, United States, 27701
Sponsors and Collaborators
Duke University
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Principal Investigator: Isaretta L Riley, MD Duke Un.
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Responsible Party: Duke University Identifier: NCT03769519    
Other Study ID Numbers: Pro00100181
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
health disparities
african american
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases