Trial Outcomes & Findings for AdheRence to Inhaled Corticosteroids in Asthma (NCT NCT03769519)
NCT ID: NCT03769519
Last Updated: 2021-12-17
Results Overview
Assessment of participants experiences with and perceptions of the ARICA program, as assessed by in-depth semi-structured qualitative interview.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
3 months
Results posted on
2021-12-17
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
15
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
AdheRence to Inhaled Corticosteroids in Asthma
Baseline characteristics by cohort
| Measure |
Control (Group 1)
n=14 Participants
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)
n=15 Participants
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.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.7 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
47.1 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
49.8 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
DOSE-Nonadherence (Voils Adherence)
|
1.6 units on a scale
STANDARD_DEVIATION 0.9 • n=5 Participants
|
1.3 units on a scale
STANDARD_DEVIATION 1 • n=7 Participants
|
1.5 units on a scale
STANDARD_DEVIATION 1 • n=5 Participants
|
|
Asthma Control Test
|
14 units on a scale
STANDARD_DEVIATION 5.5 • n=5 Participants
|
16.1 units on a scale
STANDARD_DEVIATION 4 • n=7 Participants
|
15.1 units on a scale
STANDARD_DEVIATION 4.8 • n=5 Participants
|
|
Marks Asthma Related Quality of Life
|
33.2 units on a scale
STANDARD_DEVIATION 17.7 • n=5 Participants
|
23.2 units on a scale
STANDARD_DEVIATION 17.2 • n=7 Participants
|
28 units on a scale
STANDARD_DEVIATION 17.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Conducted qualitative interview of ARICA Intervention participants who completed the study.
Assessment of participants experiences with and perceptions of the ARICA program, as assessed by in-depth semi-structured qualitative interview.
Outcome measures
| Measure |
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.
|
ARICA Intervention (Group 2)
n=14 Participants
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.
|
|---|---|---|
|
Number of Participants Who Reported Experiences With the ARICA Program
|
—
|
12 Participants
|
SECONDARY outcome
Timeframe: 3 monthspatients' medication adherence rates based on Voils adherence questionnaire adherence questionnaire. Difference from baseline to follow up. Scored 0-4, higher is more non-adherent
Outcome measures
| Measure |
Control (Group 1)
n=14 Participants
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)
n=15 Participants
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.
|
|---|---|---|
|
Change in Patient Reported Medication Adherence as Measured by the DOSE-Nonadherence (Voils) Questionnaire
|
0.685 score on a scale
Interval -0.0385 to 0.7528
|
0.738 score on a scale
Interval 0.1928 to 1.28
|
SECONDARY outcome
Timeframe: 3 monthspatient reported difference from baseline to follow up. Higher score is better asthma control. Range 5-25.
Outcome measures
| Measure |
Control (Group 1)
n=14 Participants
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)
n=14 Participants
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.
|
|---|---|---|
|
Change in Asthma Control as Measured by the Asthma Control Test
|
-2.571 score on a scale
Interval -5.1902 to 0.0473
|
-3.5 score on a scale
Interval -6.0396 to -0.9604
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Participants who completed 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.
Outcome measures
| Measure |
Control (Group 1)
n=13 Participants
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)
n=13 Participants
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.
|
|---|---|---|
|
Change in Asthma-Related Quality of Life as Measured by the Marks Asthma-Related Quality of Life Questionnaire
|
5.769 score on a scale
Interval -1.2527 to 12.7912
|
11.462 score on a scale
Interval 5.5068 to 17.4163
|
Adverse Events
Control (Group 1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ARICA Intervention (Group 2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place