Clinical trial NCT04286230: Construct Validation of the BIOTICA Questionnaire
Official title: Construct Validation of the BIOTICA Questionnaire (Barriers to Optimal Medication Adherence With Oral Antibiotics)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infectious Diseases and Manifestations
Keywords: Adherence
Oral antibiotics
Electronic monitoring
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-02-26
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The general population entering a community pharmacy.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence [%] to oral antibiotics
timeFrame: maximum 30 days
Secondary outcomes:
measure: Persistence [%] to oral antibiotics
timeFrame: maximum 30 days
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Apotheke am Spalenbärg
state: BS
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Isabelle Arnet, Dr. MD
role: PRINCIPAL_INVESTIGATOR
References: