Back to resultsAdheRence to Inhaled Corticosteroids in Asthma (ARICA)
Primary Purpose
Medication Adherence, Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ARICA
Sponsored by
About this trial
This is an interventional health services research trial for Medication Adherence focused on measuring health disparities, african american, adult
Eligibility Criteria
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
Sites / Locations
- Duke Un.
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control (Group 1)
ARICA Intervention (Group 2)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03769519
Brief Title
AdheRence to Inhaled Corticosteroids in Asthma
Acronym
ARICA
Official Title
AdheRence to Inhaled Corticosteroids in Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 27, 2020 (Actual)
Primary Completion Date
August 19, 2020 (Actual)
Study Completion Date
August 19, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Adherence, Asthma
Keywords
health disparities, african american, adult
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control (Group 1)
Arm Type
No Intervention
Arm Description
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.
Arm Title
ARICA Intervention (Group 2)
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
ARICA
Intervention Description
Personalized ARICA (AdheRence to Inhaled Corticosteroids in Asthma) intervention package.
Primary Outcome Measure Information:
Title
Number of Participants Who Reported Experiences With the ARICA Program
Description
Assessment of participants experiences with and perceptions of the ARICA program, as assessed by in-depth semi-structured qualitative interview.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in Patient Reported Medication Adherence as Measured by the DOSE-Nonadherence (Voils) Questionnaire
Description
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
Time Frame
3 months
Title
Change in Asthma Control as Measured by the Asthma Control Test
Description
patient reported difference from baseline to follow up. Higher score is better asthma control. Range 5-25.
Time Frame
3 months
Title
Change in Asthma-Related Quality of Life as Measured by the Marks Asthma-Related Quality of Life Questionnaire
Description
Patient reported. Difference from baseline to follow up. Range 0-80, higher score means greater impact of asthma on quality of life.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isaretta L Riley, MD
Organizational Affiliation
Duke Un.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Un.
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27701
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
AdheRence to Inhaled Corticosteroids in Asthma
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