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

Atrial Fibrillation Clinical Trial

Official title:

Development and Validation of a Novel Educational Program for Patients Prescribed Non-vitamin K Anticoagulants (NOAC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03124654
• Other study ID #: NOAC-Validation-study
• Status: Completed
• Phase: N/A
• First received: April 7, 2017
• Last updated: August 2, 2017
• Start date: September 1, 2016
• Est. completion date: July 30, 2017

Study information

• Verified date: August 2017
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 30, 2017
• Est. primary completion date: July 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Deep Vein Thrombosis
• Embolism
• Pulmonary Embolism
• Thrombosis
• Venous Thrombosis

Intervention

Behavioral:
• Education
Patients will receive several questionnaires to fill in. Knowledge about NOACs will be assessed with a newly developped questionnaire and an educational program will be dispensed while analysing the answers (reactive educational program).

Locations

Country	Name	City	State
Switzerland	University of Basel, Pharmaceutical Care Research Group	Basel	Basel-Stadt

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	University of Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients having an anticoagulation identification card		assessed once at visit 1 (baseline assessment)
Primary	Validation of the new questionnaire assessed by questionnaire	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.	measured once at visit 1 (baseline)
Primary	Sensitivity of the new questionnaire	Number of correct/incorrect answers measured at visit 2 before and after the educational program has been dispensed (7 days after visit 1)	7 days after visit 1, before and after the educational program
Primary	Test retest validity of the new questionnaire	Number of correct/incorrect answers measured at visit 1 and 2 (0 respectively 7 days after visit 1)	7 days
Secondary	Patient's adherence assessed by questionnaire	change in adherence between visits 1 (baseline) and visit 3	14 days
Secondary	Patient's satisfaction assessed by questionnaire	change in satisfaction between visits 1 (baseline) and visit 3	14 days
Secondary	Patient's health literacy assessed by questionnaire		assessed once at visit 1 (baseline assessment)