Medication AdherenceARICANCT03769519
AdheRence to Inhaled Corticosteroids in Asthma
A study testing ARICA in people with Medication Adherence and Asthma, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence, Asthma
- What is being tested?
- ARICA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2020to 19 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable or unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Medication Adherence, Asthma
- Being tested
- ARICA
- Keywords
- health disparities, african american, adult
- Medical subject headings
- Medication Adherence, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARICABehavioural
Personalized ARICA (AdheRence to Inhaled Corticosteroids in Asthma) intervention package.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: ARICA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (3)
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
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start27 Feb 2020
- Primary completion19 Aug 2020
- Study completion19 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isaretta L Riley, MD, Principal investigator, Duke Un.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03769519
- Sponsor's protocol ID
- Pro00100181
- Acronym
- ARICA
- Status last verified
- Nov 2021
- First submitted
- 16 Oct 2018
- Last updated
- 17 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AdheRence to Inhaled Corticosteroids in Asthma
- ClinicalTrials.gov ID
- NCT03769519
- Acronym / sponsor ID
- ARICA / Pro00100181
- Conditions
- Medication Adherence, Asthma
- Keywords
- health disparities, african american, adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 19 Aug 2020 (actual)
- Study completion
- 19 Aug 2020 (actual)
- First posted
- 7 Dec 2018 (actual)
- Results
- Posted 17 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: ARICAThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Unable or unwilling to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARICAPersonalized ARICA (AdheRence to Inhaled Corticosteroids in Asthma) intervention package. | Behavioural | ARICA Intervention (Group 2) |
Primary outcome
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.
3 secondary outcomes
Change in Patient Reported Medication Adherence as Measured by the DOSE-Nonadherence (Voils) Questionnaire
Time frame: 3 months
Change in Asthma Control as Measured by the Asthma Control Test
Time frame: 3 months
Change in Asthma-Related Quality of Life as Measured by the Marks Asthma-Related Quality of Life Questionnaire
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isaretta L Riley, MD principal investigator
Duke Un.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARICA in people with Medication Adherence and Asthma, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Reported Experiences With the ARICA Program (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2021.