Construct Validation of the BIOTICA Questionnaire

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-20

Study Completion Date

2021-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infectious Diseases and Manifestations

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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™