An interventional study of ARICA in Medication Adherence and Asthma, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-17.
Sponsored by Duke University · Not applicable, Interventional, and Health services research
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.
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 29 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: ARICA
Personalized ARICA (AdheRence to Inhaled Corticosteroids in Asthma) intervention package.
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.
Time frame: 3 months
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
Time frame: 3 months
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.
Time frame: 3 months
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.
Time frame: 3 months
| Milestone | Control (Group 1) | ARICA Intervention (Group 2) |
|---|---|---|
| Started | 14 | 15 |
| Completed | 14 | 14 |
| Not completed | 0 | 1 |
Assessment of participants experiences with and perceptions of the ARICA program, as assessed by in-depth semi-structured qualitative interview.
| Participants | Control (Group 1) | ARICA Intervention (Group 2) |
|---|---|---|
| Number of Participants Who Reported Experiences With the ARICA Program | — | 12 |
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
| score on a scale | Control (Group 1) | ARICA Intervention (Group 2) |
|---|---|---|
| Change in Patient Reported Medication Adherence as Measured by the DOSE-Nonadherence (Voils) Questionnaire | 0.685 (-0.0385 to 0.7528) | 0.738 (0.1928 to 1.28) |
patient reported difference from baseline to follow up. Higher score is better asthma control. Range 5-25.
| score on a scale | Control (Group 1) | ARICA Intervention (Group 2) |
|---|---|---|
| Change in Asthma Control as Measured by the Asthma Control Test | -2.571 (-5.1902 to 0.0473) | -3.5 (-6.0396 to -0.9604) |
Patient reported. Difference from baseline to follow up. Range 0-80, higher score means greater impact of asthma on quality of life.
| score on a scale | Control (Group 1) | ARICA Intervention (Group 2) |
|---|---|---|
| Change in Asthma-Related Quality of Life as Measured by the Marks Asthma-Related Quality of Life Questionnaire | 5.769 (-1.2527 to 12.7912) | 11.462 (5.5068 to 17.4163) |
Collected over Study period, 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control (Group 1) | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| ARICA Intervention (Group 2) | 1/15 (6.7%) | 0/15 (0%) | 0/15 (0%) |
| Age, Continuous(years) | Control (Group 1) | ARICA Intervention (Group 2) | Total |
|---|---|---|---|
| Mean | 52.7 ± 12.2 | 47.1 ± 10.5 | 49.8 ± 11.5 |
| Sex: Female, Male(Participants) | Control (Group 1) | ARICA Intervention (Group 2) | Total |
|---|---|---|---|
| Female | 13 | 14 | 27 |
| Male | 1 | 1 | 2 |
| Ethnicity (NIH/OMB)(Participants) | Control (Group 1) | ARICA Intervention (Group 2) | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 13 | 15 | 28 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Control (Group 1) | ARICA Intervention (Group 2) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 13 | 14 | 27 |
| White | 0 | 0 | 0 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Control (Group 1) | ARICA Intervention (Group 2) | Total |
|---|---|---|---|
| United States | 14 | 15 | 29 |
| DOSE-Nonadherence (Voils Adherence)(units on a scale) | Control (Group 1) | ARICA Intervention (Group 2) | Total |
|---|---|---|---|
| Mean | 1.6 ± 0.9 | 1.3 ± 1 | 1.5 ± 1 |
| Asthma Control Test(units on a scale) | Control (Group 1) | ARICA Intervention (Group 2) | Total |
|---|---|---|---|
| Mean | 14 ± 5.5 | 16.1 ± 4 | 15.1 ± 4.8 |
| Marks Asthma Related Quality of Life(units on a scale) | Control (Group 1) | ARICA Intervention (Group 2) | Total |
|---|---|---|---|
| Mean | 33.2 ± 17.7 | 23.2 ± 17.2 | 28 ± 17.9 |
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