Asthma, Medication Adherence
Conditions
Keywords
health disparities, african american, adult
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.
Interventions
BEHAVIORALARICA
Personalized ARICA (AdheRence to Inhaled Corticosteroids in Asthma) intervention package.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Reported Experiences With the ARICA Program | 3 months | Assessment of participants experiences with and perceptions of the ARICA program, as assessed by in-depth semi-structured qualitative interview. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Reported Medication Adherence as Measured by the DOSE-Nonadherence (Voils) Questionnaire | 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 |
| Change in Asthma Control as Measured by the Asthma Control Test | 3 months | 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 | 3 months | Patient reported. Difference from baseline to follow up. Range 0-80, higher score means greater impact of asthma on quality of life. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| 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.
ARICA: Personalized ARICA (AdheRence to Inhaled Corticosteroids in Asthma) intervention package. | 15 |
| Total | 29 |
Baseline characteristics
| Characteristic | ARICA Intervention (Group 2) | Total | Control (Group 1) |
|---|---|---|---|
| Age, Continuous | 47.1 years STANDARD_DEVIATION 10.5 | 49.8 years STANDARD_DEVIATION 11.5 | 52.7 years STANDARD_DEVIATION 12.2 |
| Asthma Control Test | 16.1 units on a scale STANDARD_DEVIATION 4 | 15.1 units on a scale STANDARD_DEVIATION 4.8 | 14 units on a scale STANDARD_DEVIATION 5.5 |
| DOSE-Nonadherence (Voils Adherence) | 1.3 units on a scale STANDARD_DEVIATION 1 | 1.5 units on a scale STANDARD_DEVIATION 1 | 1.6 units on a scale STANDARD_DEVIATION 0.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 28 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Marks Asthma Related Quality of Life | 23.2 units on a scale STANDARD_DEVIATION 17.2 | 28 units on a scale STANDARD_DEVIATION 17.9 | 33.2 units on a scale STANDARD_DEVIATION 17.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 27 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 15 participants | 29 participants | 14 participants |
| Sex: Female, Male Female | 14 Participants | 27 Participants | 13 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 1 / 15 |
| other Total, other adverse events | 0 / 14 | 0 / 15 |
| serious Total, serious adverse events | 0 / 14 | 0 / 15 |
Outcome results
Primary
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
Population: Conducted qualitative interview of ARICA Intervention participants who completed the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ARICA Intervention (Group 2) | Number of Participants Who Reported Experiences With the ARICA Program | 12 Participants |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control (Group 1) | Change in Asthma Control as Measured by the Asthma Control Test | -2.571 score on a scale |
| ARICA Intervention (Group 2) | Change in Asthma Control as Measured by the Asthma Control Test | -3.5 score on a scale |
Secondary
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
Population: Participants who completed the Marks Asthma-Related Quality of Life Questionnaire.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control (Group 1) | Change in Asthma-Related Quality of Life as Measured by the Marks Asthma-Related Quality of Life Questionnaire | 5.769 score on a scale |
| ARICA Intervention (Group 2) | Change in Asthma-Related Quality of Life as Measured by the Marks Asthma-Related Quality of Life Questionnaire | 11.462 score on a scale |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control (Group 1) | Change in Patient Reported Medication Adherence as Measured by the DOSE-Nonadherence (Voils) Questionnaire | 0.685 score on a scale |
| ARICA Intervention (Group 2) | Change in Patient Reported Medication Adherence as Measured by the DOSE-Nonadherence (Voils) Questionnaire | 0.738 score on a scale |