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AdheRence to Inhaled Corticosteroids in Asthma (ARICA)

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ClinicalTrials.gov Identifier: NCT03769519
Recruitment Status : Completed
First Posted : December 7, 2018
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE October 16, 2018
First Posted Date  ICMJE December 7, 2018
Last Update Posted Date September 14, 2020
Actual Study Start Date  ICMJE February 27, 2020
Actual Primary Completion Date August 19, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2020)
  • 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
  • Change in Asthma Control as measured by the Asthma Control Test [ Time Frame: 3 months ]
    patient reported
  • Change in Asthma-Related Quality of Life as measured by the Marks Asthma-Related Quality of Life Questionnaire [ Time Frame: 3 months ]
    patient reported
Original Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
  • Change in Medication Adherence [ Time Frame: 6 months ]
    patient-reported
  • Change in Medication Possession Ratio [ Time Frame: 6 months ]
    pharmacy refill rates
  • Change in Asthma Knowledge [ Time Frame: 6 months ]
    patient reported
  • Change in Asthma Medication Attitudes [ Time Frame: 6 months ]
    patient reported
  • Change in Patient-Reported Asthma Self-Efficacy as measured by the KASE-AQ [ Time Frame: 6 months ]
    patient reported
  • Change in Asthma Control [ Time Frame: 6 months ]
    patient reported
  • Change in Asthma Exacerbations [ Time Frame: 6 months ]
    patient reported
  • Change in Asthma-Related Quality of Life as measured by the Marks Asthma Quality of Life Questionnaire [ Time Frame: 6 months ]
    patient reported
  • Change in Patient-Provider Communication [ Time Frame: 6 months ]
    patient reported
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AdheRence to Inhaled Corticosteroids in Asthma
Official Title  ICMJE AdheRence to Inhaled Corticosteroids in Asthma
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Medication Adherence
  • Asthma
Intervention  ICMJE Behavioral: ARICA
Personalized ARICA (AdheRence to Inhaled Corticosteroids in Asthma) intervention package.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: ARICA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 11, 2020)
30
Original Estimated Enrollment  ICMJE
 (submitted: December 6, 2018)
32
Actual Study Completion Date  ICMJE August 19, 2020
Actual Primary Completion Date August 19, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03769519
Other Study ID Numbers  ICMJE Pro00100181
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Isaretta L Riley, MD Duke Un.
PRS Account Duke University
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP