Construct Validation of the BIOTICA Questionnaire

Infectious Diseases and Manifestations Clinical Trial

— BIOTICA  

Official title:

Construct Validation of the BIOTICA Questionnaire (Barriers to Optimal Medication Adherence With Oral Antibiotics)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04286230
• Other study ID #: 2020-00069
• Status: Completed
• Start date: February 20, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: August 2021
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: July 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infectious Diseases and Manifestations

Intervention

Behavioral:
• Adherence 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.
• Persistence 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.

Locations

Country	Name	City	State
Switzerland	Apotheke am Spalenbärg	Basel	BS

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence [%] to oral antibiotics	The primary endpoint is the adherence [%] to oral antibiotics calculated as correct dosing days from the electronic adherence data	maximum 30 days
Secondary	Persistence [%] to oral antibiotics	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	maximum 30 days