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AdheRence to Inhaled Corticosteroids in Asthma (ARICA)

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ClinicalTrials.gov Identifier: NCT03769519
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : May 21, 2019
Sponsor:
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 32 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)
Estimated Enrollment : 32 participants
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 : January 15, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids

Arm Intervention/treatment
Experimental: ARICA Intervention 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: 6 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 Questionnare [ Time Frame: 6 months ]
  2. Change in Medication Possession Ratio [ Time Frame: 6 months ]
    pharmacy refill rates

  3. Change in Asthma Knowledge as measured by by the Knowledge, Attitudes, Self-Efficacy Asthma Questionnaire [ Time Frame: 6 months ]
    patient reported

  4. Change in patient-reported asthma medication attitudes as measured by the Knowledge, Attitudes, Self-Efficacy Asthma Questionnaire [ Time Frame: 6 months ]
    patient reported

  5. Change in Patient-Reported Asthma Self-Efficacy as measured by the Knowledge, Attitudes, Self-Efficacy Asthma Questionnaire [ Time Frame: 6 months ]
    patient reported

  6. Change in Asthma Control as measured by the Asthma Control Test [ Time Frame: 6 months ]
    patient reported

  7. Change in Asthma Exacerbations [ Time Frame: 6 months ]
    patient reported

  8. Change in Asthma-Related Quality of Life as measured by the Marks Asthma-Related Quality of Life Questionnaire [ Time Frame: 6 months ]
    patient reported

  9. Change in Patient-Provider Communication as measured by the Interpersonal Process of Care Survey- Communication domain [ Time Frame: 6 months ]
    patient reported



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 ClinicalTrials.gov identifier (NCT number): NCT03769519


Contacts
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Contact: Isaretta Riley, MD, MPH 919-668-0452 isaretta.riley@duke.edu
Contact: Jennie Clinical Research Coordinator, MS 919-668-0452 jennie.riley@duke.edu

Locations
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United States, North Carolina
Duke Un. Recruiting
Durham, North Carolina, United States, 27701
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Isaretta L Riley, MD Duke Un.

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03769519     History of Changes
Other Study ID Numbers: Pro00100181
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: October 2018
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
adult

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases