N/A
N=53
PackHealth: Asthma Engagement Tool
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT02413684 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Rate of Asthma Exacerbations — 3.21 events/12 weeks
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Patient engagement toolkit (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Asthma Exacerbations |
1.25 | — |
| PRIMARY Rate of Asthma Exacerbations |
1.25 | — |
| SECONDARY Change in Asthma Control |
1.67 | — |
| SECONDARY Change in Asthma Symptoms |
0.095 | — |
| SECONDARY Change in Pulmonary Function Tests |
0.022 | — |
| SECONDARY Number of Emergency Department and Hospitalization Visits |
0.37 | — |
| SECONDARY Number of Emergency Department and Hospitalization Visits |
0.37 | — |
Summary
The purpose of this study is to test the impact of an innovative patient engagement solution on patient's quality of life and asthma-related outcomes, and evaluate the correlation between a patient reported outcome measure and clinical outcomes.
Eligibility Criteria
Inclusion Criteria
- Patients with a physician diagnosis of asthma for at least the previous 12 months.
- Asthma that is not well controlled by NAEPP guidelines.
- Ability and willingness to provide informed consent
Exclusion Criteria
- Significant alcohol consumption of more than three alcoholic drinks per day or active substance abuse.
- Chronic disease (other than asthma) that in the opinion of the investigator would prevent participation in the trial or put the participant at risk by participation e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney, endocrine or nervous system or immunodeficiency that are not well addressed or controlled.
- A diagnosis of cancer with ongoing treatment.
- Any terminal illness or conditions that results in a life expectancy less than one year.
Data sourced from ClinicalTrials.gov (NCT02413684). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.