Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations; PeRson EmPowered Asthma RElief (PREPARE)
Asthma imposes a significant burden in the US in terms of morbidity, costs to society, individual suffering, loss of productivity and mortality. African Americans (AA) and Hispanic/Latinos (H/L) bear a disproportionate share of that morbidity. Despite national guidelines for asthma treatment, the gap between these groups and whites has been stable or widening. The need for pragmatic research to address the continuing burden is widely recognized. Patients use asthma reliever inhalers to provide immediate relief of symptoms. Controller inhalers (inhaled corticosteroids (ICS)) are intended to be used regularly to prevent symptoms and attacks. Guidelines suggest that they be used daily, on a fixed basis, in all but the mildest asthma. However, adherence by patients and implementation of evidence-based guideline recommendations by clinicians has been poor. Gap analysis suggests that it is difficult to improve adherence to the current recommendations without complex and resource-intensive interventions. Studies have examined symptom-activated use of ICS triggered by use of a reliever medication. The Investigators call this approach PARTICS - Patient Activated Reliever-Triggered Inhaled CorticoSteroid. Explanatory, non-real world studies suggest that PARTICS can produce up to 50% reductions in asthma attacks compared with usual care, while reducing ICS use by half or more. These studies have been performed in pre-selected populations, which represent less than 5% of asthma patients. The previous studies have been done with repeated education and adherence checks in both the intervention and control arms. The Investigators aim to determine whether PARTICS can reduce asthma morbidity in AA and H/L.
This research study is led by Dr. Victor Pinto-Plata.
Contact: Sarah Romain, 413-794-4889
Pulmonary/ Critical Care
Baystate Medical Center, 759 Chestnut St, Springfield, MA
Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
- Black or Hispanic based on self-identification (Hispanic if identify as both)
- Male and female, ages 18-75 years
- Clinical history consistent with asthma for > 1 year.
- Prescribed ICS as daily maintenance therapy
- Participant must also have an ACT score of 19 or less, or a history of one or more exacerbations in the past year that required patient report of systemic corticosteroid use.
- Life expectancy less than one year
- Known allergy to the ICS inhaler used in the study
- Regular systemic corticosteroid use daily or every other day for any reason—including asthma or other medical reasons
- Another family member living in the same household already enrolled in study
Interventional (Clinical Trial), Randomized