Better Outcomes For Everybody (BOFE) evaluates the effectiveness and cost-effectiveness of a pharmacist-led intervention, delivered by community pharmacists in collaboration with physicians, in improving disease control, compared with usual care, in asthma and COPD patients during and after COVID-19: study protocol for a pragmatic, parallel randomised controlled trial

SOFAD srl0 个研究点目标入组 835 人开始时间: 2021年6月15日最近更新: 2023年6月20日

试验速览

2021 Protocol article in http://dx.doi.org/10.1097/MD9.0000000000000158 Peer-reviewed protocol article (added 12/07/2022)

•Pharmacies must have:
•1. A private area for private consultation with patients
•2. And/or telephone, smartphone, tablet or other devices allowing remote consultation with their patients if required due to COVID-19 restrictions
•3. An internet connection
•Pharmacists must:
•1. Be qualified and registered with the Italian Pharmacy Board practising in Italy
•2. Have experiences in providing advice to patients
•3. Have already provided one or more services, such as blood pressure monitoring, smoking cessation, cholesterol monitoring, signposting, food intolerance testing (this will be verified during the recruitment process asking for a self-declaration)
•4. Be able to attend the full training session(s)
•Patients must:
•1. Be at least 18 years of age
•2. Have been diagnosed with either asthma or COPD, for at least 6 months before enrolment to the study
•3. Have a prescription(s) for asthma/COPD medications with R03 as ATC code (Anatomical, Therapeutic Chemical Classification), or drugs for obstructive airways disease

•Pharmacies must be excluded if they:
•1. Have no internet access
•2. No consultation room or no telephone, smartphone, tablet or other devices allowing remote consultation with their patients if required due to COVID-19 restrictions
•3. Are currently involved in any other clinical pharmacy research project
•Patients must be excluded if they:
•1. Have a terminal illness (defined as an advanced stage of a disease with an unfavourable prognosis and no known cure) as identified by the pharmacists through the prescription coding
•2. Are currently enrolled in another clinical trial
•3. Do not self-administer their medications (e.g. inhaler)
•4. Are not able to communicate well in Italian, both written and spoken

发起方

SOFAD srl