TY - JOUR
T1 - A randomized, open-label, pragmatic study to assess reliever-triggered inhaled corticosteroid in African American/Black and Hispanic/Latinx adults with asthma
T2 - Design and methods of the PREPARE trial
AU - Israel, Elliot
AU - Cardet, Juan Carlos
AU - Carroll, Jennifer K.
AU - Fuhlbrigge, Anne L.
AU - Pace, Wilson D.
AU - Maher, Nancy E.
AU - She, Lilin
AU - Rockhold, Frank W.
AU - Fagan, Maureen
AU - Forth, Victoria E.
AU - Hernandez, Paulina Arias
AU - Manning, Brian K.
AU - Rodriguez-Louis, Jacqueline
AU - Shields, Joel B.
AU - Coyne-Beasley, Tamera
AU - Kaplan, Barbara M.
AU - Rand, Cynthia S.
AU - Morales-Cosme, Wilfredo
AU - Wechsler, Michael E.
AU - Wisnivesky, Juan P.
AU - White, Mary
AU - Yawn, Barbara P.
AU - McKee, M. Diane
AU - Busse, Paula J.
AU - Kaelber, David C.
AU - Nazario, Sylvette
AU - Hernandez, Michelle L.
AU - Apter, Andrea J.
AU - Chang, Ku Lang
AU - Pinto-Plata, Victor
AU - Stranges, Paul M.
AU - Hurley, Laura P.
AU - Trevor, Jennifer
AU - Casale, Thomas B.
AU - Chupp, Geoffrey
AU - Riley, Isaretta L.
AU - Shenoy, Kartik
AU - Pasarica, Magdalena
AU - Calderon-Candelario, Rafael A.
AU - Tapp, Hazel
AU - Baydur, Ahmet
N1 - Publisher Copyright:
© 2020
PY - 2021/2
Y1 - 2021/2
N2 - Background: Asthma prevalence, morbidity, and mortality disproportionately impact African American/Black (AA/B) and Hispanic/Latinx (H/L) communities. Adherence to daily inhaled corticosteroid (ICS), recommended by asthma guidelines in all but the mildest cases of asthma, is generally poor. As-needed ICS has shown promise as a patient-empowering asthma management strategy, but it has not been rigorously studied in AA/B or H/L patients or in a real-world setting. Design and Aim The PeRson EmPowered Asthma RElief (PREPARE) Study is a randomized, open-label, pragmatic study which aims to assess whether a patient-guided, reliever-triggered ICS strategy called PARTICS (Patient-Activated Reliever-Triggered Inhaled CorticoSteroid) can improve asthma outcomes in AA/B and H/L adult patient populations. In designing and implementing the study, the PREPARE research team has relied heavily on advice from AA/B and H/L Patient Partners and other stakeholders. Methods PREPARE is enrolling 1200 adult participants (600 AA/Bs, 600H/Ls) with asthma. Participants are randomized to PARTICS + Usual Care (intervention) versus Usual Care (control). Following a single in-person enrollment visit, participants complete monthly questionnaires for 15 months. The primary endpoint is annualized asthma exacerbation rate. Secondary endpoints include asthma control; preference-based quality of life; and days lost from work, school, or usual activities. Discussion The PREPARE study features a pragmatic design allowing for the real-world assessment of a patient-centered, reliever-triggered ICS strategy in AA/B and H/L patients. Outcomes of this study have the potential to offer powerful evidence supporting PARTICS as an effective asthma management strategy in patient populations that suffer disproportionately from asthma morbidity and mortality.
AB - Background: Asthma prevalence, morbidity, and mortality disproportionately impact African American/Black (AA/B) and Hispanic/Latinx (H/L) communities. Adherence to daily inhaled corticosteroid (ICS), recommended by asthma guidelines in all but the mildest cases of asthma, is generally poor. As-needed ICS has shown promise as a patient-empowering asthma management strategy, but it has not been rigorously studied in AA/B or H/L patients or in a real-world setting. Design and Aim The PeRson EmPowered Asthma RElief (PREPARE) Study is a randomized, open-label, pragmatic study which aims to assess whether a patient-guided, reliever-triggered ICS strategy called PARTICS (Patient-Activated Reliever-Triggered Inhaled CorticoSteroid) can improve asthma outcomes in AA/B and H/L adult patient populations. In designing and implementing the study, the PREPARE research team has relied heavily on advice from AA/B and H/L Patient Partners and other stakeholders. Methods PREPARE is enrolling 1200 adult participants (600 AA/Bs, 600H/Ls) with asthma. Participants are randomized to PARTICS + Usual Care (intervention) versus Usual Care (control). Following a single in-person enrollment visit, participants complete monthly questionnaires for 15 months. The primary endpoint is annualized asthma exacerbation rate. Secondary endpoints include asthma control; preference-based quality of life; and days lost from work, school, or usual activities. Discussion The PREPARE study features a pragmatic design allowing for the real-world assessment of a patient-centered, reliever-triggered ICS strategy in AA/B and H/L patients. Outcomes of this study have the potential to offer powerful evidence supporting PARTICS as an effective asthma management strategy in patient populations that suffer disproportionately from asthma morbidity and mortality.
KW - African American
KW - Asthma
KW - Exacerbations
KW - Hispanic
KW - Patient-centered
KW - Pragmatic trial
UR - http://www.scopus.com/inward/record.url?scp=85098230477&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85098230477&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2020.106246
DO - 10.1016/j.cct.2020.106246
M3 - Article
C2 - 33316456
AN - SCOPUS:85098230477
SN - 1551-7144
VL - 101
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
M1 - 106246
ER -