Authors
»
Boyle, Robert -More
Category
»
Primary study
Registry of Trials»ISRCTN registry
Year
»
2013
INTERVENTION: Both groups receive an advice leaflet aimed at reducing the rate of respiratory infections for the 6‐month period of October to March. This will be sent out to participants at the time of their letters which invite them to attend their annual influenza vaccination. The standard advice leaflet contains the following headings: ?Flu jabs?, ?Catch it, bin it, kill it?, ?Hand hygiene? and ?Inhaler technique and asthma control? and the additional advice leaflet has everything similar to a standard leaflet but with an additional section headed ?Probiotics?. 1. Standard advice group: This group will receive advice about receiving their influenza vaccination, decontaminating hands that have may carry their own or have come into contact with other people's germs and attending asthma clinics to ensure good asthma control and inhaler technique. 2. Additional advice group: In addition to all the advice received by the standard advice group, this group will also receive written advice that probiotic consumption can reduce respiratory infections. As well as the advice leaflet, this group will also receive three vouchers, each covering a different 2‐month period for October 2013 to March 2014, enabling them to receive free Lab4 probiotic capsules from Cultech via their website or mail order. Following the 6‐month period, unless participants have opted out of us doing so, one of the trial doctors who is also a GP at the participants' surgery will look at their primary care medical records to see whether they have received antibiotics or consulted regarding a respiratory infection during the 6‐month period from October 2013 to March 2014. Data will also be provided by Cultech as to who opted to receive probiotic from them during this time. A range of contact methods are available for patients to opt out of inclusion in the data analysis for which their medical records will be looked at by one of their doctors. CONDITION: Asthma ; Respiratory ; Asthma PRIMARY OUTCOME: Percentage of group prescribed at least one of the following antibiotics in primary care during the 6‐month period for which probiotic consumption is recommended: Amoxicillin, Azithromycin, Cefaclor, Cefalexin, Ciprofloxacin, Clarithromycin, Co‐amoxiclav, Doxycycline, Erythromycin, Phenoxymethylpenicillin INCLUSION CRITERIA: 1. Patients registered at Ashfields Primary Care Centre (UK) 2. Aged 5 years or more SECONDARY OUTCOME: Current secondary outcome measures as of 09/05/2014:; 1. Total number of antibiotic prescriptions for the above antibiotics in each group provided by the GP surgery. This is another way of measuring effects on antibiotic prescribing; 2. Total number of the above listed antibiotic prescriptions issued by the GP surgery for per group during the 6 month study period; 3. Total cost of the above listed antibiotic prescriptions during the 6 month study period per group. This will be based on the NHS drug tariff for England and Wales at the time the prescription was issued; 4. Percentage of group prescribed at least one course of any type of oral antibiotics by the GP surgery; 5. Total number of any type of oral antibiotic prescriptions issued by the GP surgery per group during the 6 months; 6. Total cost of any type of oral antibiotic prescriptions per group. This will be based on the NHS drug tariff for England and Wales at the time the prescription was issued; 7. Total number of URTI episodes for which antibiotics were issued; 8. Percentage of group having at least 1 URTI episode for which antibiotics were prescribed; 9. Total number of all respiratory episodes for which antibiotics were issued; 10. Percentage of group having at least 1 respiratory episode for which antibiotics were prescribed; 11. Percentage of patients consulting at least once for an URTI during this 6 month period; 12. Total number of URTI episodes per group during the 6 month period for which Lab4 is to be recommended; 13. Percentage of patients consulting at least once for an LRTI during this 6 month period; 14. Total number of LRTI episodes per group during the 6 month period for which Lab4 is to be recommended; 15. Percentage of patients consulting at least once for an acute exacerbation of asthma during the 6 months; 16. Total number of acute asthma exacerbation episodes per group during the 6 months; 17. Percentage of patients consulting at least once with acute respiratory symptoms during this time. This might be due to URTI, LRTI, influenza, flu‐like illness or an exacerbation of asthma; 18. Total number of acute respiratory episodes for each group as a whole; 19. Percentage of participants obtaining Lab4 at any time in the 6 month period for which it was suggested; 20. Percentage of participants obtaining deliveries of Lab4 2 or 3 times during this time; ; Previous secondary outcome measures:; 1.Total number of antibiotic prescriptions prescribed in primary care for any of the above antibiotics during the 6 months for the whole group; 2. Percentage of group prescribed any type of oral antibiotics in primary care at least once during the 6‐month period; 3. Total number of oral antibiotic prescriptions issued in primary care during the 6 months for the whole group; 4. Total cost (based on current BNF prices) of antibiotic prescriptions per group; 5. Percentage of patients consulting at least once for symptoms of URTI during this time; 6. Total number of consultations with symptoms of URTI for the group within the 6‐month period; 7. Percentage of patients consulting at least once with acute respiratory symptoms (suggestive of URTI, LRTI, influenza, flu‐like illness or exacerbation of asthma) during this time; 8. Total number of consultations with acute respiratory symptoms for the group within the 6‐month period; 9. Percentage of people taking Lab4 at any point during the 6‐month period for which it was suggested; 10. Percentage of people taking Lab4 on more than half of the days during this time
Epistemonikos ID: 8433521145140d0684ce1241dbeefcda8b2e82a7
First added on: Aug 22, 2024