Asthma and Chronic Obstructive Pulmonary Disease (COPD) Respiratory Asthma, Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
The duration of the trial is 24 months with a 12-month follow-up. Pharmacists will encounter their patients five times, at baseline and every 3 months.
Power calculation
CCQ <2) versus non-controlled (ACT <20
CCQ =2). A 2:1 randomisation and sample size of 887 patients (591 in the IG and 296 in the CG) will be enough to detect a difference of 15% between the intervention and control group using a dichotomi
the results were assessed and confirmed by a senior statistician working at UCLan’s Clinical Trial Unit (CTU).
Pharmacist patient ratio
The researchers decided to roun
therefore, they aim to recruit 100 pharmacists and 900 consecutive patients (asthma = 450
COPD = 450), with a pharmacist-patient ratio of 1:9, meaning that each pharmacist will recruit and follow-up nine patients.
Randomisation, allocation and sequence generation
Sponsors
SOFAD srl
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Asthma and COPD control assessed using the Asthma Control Test (ACT score) and the Clinical COPD Questionnaire (CCQ) score at baseline and 12 months (according to the patients' disease) at 3-month intervals | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Reduction of the risk of having asthma and COPD uncontrolled, assessed using the ACT and CCQ scores assessed at baseline and 3-month intervals, as reported by patients 2. The number of active ingredients used by patients, as reported by patients at baseline and 12 months at each 3-month interval 3. Patients' self-reported adherence to asthma/COPD medications measured using the questions used in the I-MUR study at baseline and 12 months assessed at 3-month intervals 4. Pharmaceutical care issues measured using the questions used in the I-MUR study at baseline and 12 months assessed at 3-month intervals 5. The minimal clinical important difference (MCID) in ACT score and CCQ, as reported by patients at baseline and 12 months assessed at 3-month intervals 6. Cost-effectiveness of CRC-MUR asthma/COPD service compared with usual care, measured in terms of cost per quality-adjusted life-year (QALY) as a measure of disease burden, including both the quality and the quantity of life gained, at 12-month follow-up | — |
Countries
Italy
Outcome results
None listed