Better Outcomes for Everybody: a study to evaluate whether a new service delivered by community pharmacists in collaboration with physicians to asthma and COPD patients, improves disease control and is value for money, compared with usual care, during and after COVID-19

Not Applicable

• Conditions: Asthma and Chronic Obstructive Pulmonary Disease (COPD); Respiratory; Asthma, Chronic obstructive pulmonary disease, unspecified

• Registration Number: ISRCTN38734433
• Lead Sponsor: SOFAD srl

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-15
• Last Update Posted: 20 June 2023
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 835

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified