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OpenTrials
Completed

NCT Number: NCT03769519

AdheRence to Inhaled Corticosteroids in Asthma

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.

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Key information

Conditions

Medication Adherence Asthma Behavior Bronchial Diseases Health Behavior Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Patient Acceptance of Health Care Patient Compliance Respiratory Hypersensitivity Respiratory Tract Diseases Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Un.

Durham, North Carolina, 27701, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ARICA

Behavioral

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

Primary outcomes

  1. Number of Participants Who Reported Experiences With 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 outcomes

  1. Change in Patient Reported Medication Adherence as Measured by the DOSE-Nonadherence (Voils) Questionnaire

    Time frame: 3 months

    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

  2. Change in Asthma Control as Measured by the Asthma Control Test

    Time frame: 3 months

    patient reported difference from baseline to follow up. Higher score is better asthma control. Range 5-25.

  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. Difference from baseline to follow up. Range 0-80, higher score means greater impact of asthma on quality of life.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Acronym: ARICA

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 7, 2018
Registry last updated
Dec 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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