Infectious Diseases and Manifestations
Conditions
Keywords
Adherence, Oral antibiotics, Electronic monitoring
Brief summary
Based on barriers identified in a systematic literature search, a self-report questionnaire called BIOTICA has been developed by the research team to assess medication adherence barriers to oral AB. The purpose of the BIOTICA-questionnaire is to detect individual barriers that prevent the optimal intake of oral AB and thus, lead to inadequate adherence or persistence to the regimen. A study is now needed to establish construct validity. Correlation between the answers to the BIOTICA-questionnaire and the electronically monitored intake of the oral AB will be analyzed in the general population.
Detailed description
Global consumption of oral antibiotics (AB) is increasing, with 80% of all prescriptions in Europe stemming from primary care, mostly against respiratory tract infections. Adequate intake behavior (i.e. adherence) to oral AB is vital to prevent therapeutic failure, to reduce the risk of microbial resistance, to reduce health care consumption, medication waste and environmental pollution. However, non-adherence among oral AB users reaches rates of 21%-38% during an AB treatment course. To improve medication adherence, understanding patient barriers to treatment is crucial. Based on barriers identified in a systematic literature search, a self-report questionnaire called BIOTICA has been developed by the research team to assess medication adherence barriers to oral AB. The purpose of the BIOTICA-questionnaire is to detect individual barriers that prevent the optimal intake of oral AB and thus, lead to inadequate adherence or persistence to the regimen. A study is now needed to establish construct validity (also called criterion, convergent or concurrent validity) that is, to generate evidence that the questionnaire measures what it is intended to. Thus, the instrument under investigation (i.e. BIOTICA-questionnaire) will be distributed at the same time as the targeted attribute (i.e. adherence to oral AB) will be electronically monitored in the general population. The correlation between the two measurements will be analyzed.
Interventions
BEHAVIORALAdherence to oral antibiotics assessed by Questionnaire
The purpose of the BIOTICA-questionnaire is to detect individual barriers preventing the optimal intake of oral antibiotics and thus, leading to inadequate adherence or persistence to the regimen.
BEHAVIORALPersistence to oral antibiotics assessed by Questionnaire
The purpose of the BIOTICA-questionnaire is to detect individual barriers preventing the optimal intake of oral antibiotics and thus, leading to inadequate adherence or persistence to the regimen.
Sponsors
University Hospital, Basel, Switzerland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* is ≥ 18 years * has a prescription for an oral AB for 3-30 days * self-manages medication * is able to read and understand the German language * signs the Informed Consent Form (ICF) * accepts to record the intake of oral AB with the electronic device Time4Med™
Exclusion criteria
* is cognitively impaired * is currently pregnant or actively trying to get pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence [%] to oral antibiotics | maximum 30 days | The primary endpoint is the adherence \[%\] to oral antibiotics calculated as correct dosing days from the electronic adherence data |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Persistence [%] to oral antibiotics | maximum 30 days | The secondary endpoint is persistence \[%\] to oral antibiotics defined as the time until medication discontinuation and calculated as the percentage of days with at least one intake |
Countries
Switzerland
Outcome results
None listed