Development of a Questionnaire to Assess Patient Knowledge About Non-vitamin K Anticoagulants (NOAC)

Completed

• Conditions: Atrial Fibrillation; Pulmonary Embolism; Deep Vein Thrombosis
• Interventions: Behavioral: Education

• Registration Number: NCT03124654
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

Pharmacists are in the best position to counsel and educate patients on anticoagulant agents such as NOACs. This should enable patients to play a more active role in their treatment and ultimately enhance adherence behaviour. However, educational elements should be targeted to knowledge. Thus, the investigators will develop and validate a questionnaire that can assess knowledge about NOACs

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-01
• Study First Submitted: 2017-04-07
• Study First Submitted QC: 2017-04-18
• Study First Posted: 2017-04-24
• Primary Completion: 2017-07-30
• Study Completion: 2017-07-30
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-02
• Last Update Posted: 2017-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Intake of a NOACs (Rivaroxaban, Edoxaban, Dabigatran, Apixaban)
• ≥18 years
• Able to give written Informed consent in German

Exclusion Criteria

• NOACs for orthopaedic indication
• Dementia in medical history

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Education	Education	-

Primary Outcome Measures

Name	Time	Method
Validation of the new questionnaire assessed by questionnaire	measured once at visit 1 (baseline)	Patients will rate on a 4-point likert scale feasibility, acceptability and comprehension of the new questionnaire immediately after the questionnaire had been filled in the first time.
Sensitivity of the new questionnaire	7 days after visit 1, before and after the educational program	Number of correct/incorrect answers measured at visit 2 before and after the educational program has been dispensed (7 days after visit 1)
Test retest validity of the new questionnaire	7 days	Number of correct/incorrect answers measured at visit 1 and 2 (0 respectively 7 days after visit 1)

Secondary Outcome Measures

Name	Time	Method
Patient's adherence assessed by questionnaire	14 days	change in adherence between visits 1 (baseline) and visit 3
Patient's satisfaction assessed by questionnaire	14 days	change in satisfaction between visits 1 (baseline) and visit 3
Patient's health literacy assessed by questionnaire	assessed once at visit 1 (baseline assessment)

Trial Locations

Locations (1)

University of Basel, Pharmaceutical Care Research Group; 🇨🇭 Basel, Basel-Stadt, Switzerland