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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (Group 1) | No Intervention | 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. | |
| ARICA Intervention (Group 2) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARICA | Behavioral | Personalized ARICA (AdheRence to Inhaled Corticosteroids in Asthma) intervention package. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months |
| Change in Asthma Control as Measured by the Asthma Control Test |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isaretta L Riley, MD | Duke Un. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Un. | Durham | North Carolina | 27701 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | ARICA Intervention (Group 2) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Conducted qualitative interview of ARICA Intervention participants who completed the study. | Posted | Count of Participants | Participants | 3 months |
|
Study period, 3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Isaretta L. Riley, MD, MPH | Duke | 919-286-0411 | isaretta.riley@duke.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 14, 2020 | Nov 18, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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patient reported difference from baseline to follow up. Higher score is better asthma control. Range 5-25. |
| 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. | 3 months |
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| DOSE-Nonadherence (Voils Adherence) | patients' medication adherence rates based on Voils adherence questionnaire adherence questionnaire. Scored 0-4, higher is more non-adherent | Mean | Standard Deviation | units on a scale |
|
| Asthma Control Test | Mean | Standard Deviation | units on a scale |
|
| Marks Asthma Related Quality of Life | Mean | Standard Deviation | units 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 | Posted | Mean | 95% Confidence Interval | score on a scale | 3 months |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 3 months |
|
|
|
| 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. | Participants who completed the Marks Asthma-Related Quality of Life Questionnaire. | Posted | Mean | 95% Confidence Interval | score on a scale | 3 months |
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| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | 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. | 1 | 15 | 0 | 15 | 0 | 15 |
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| D001519 | Behavior |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |