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

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

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

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Deep Vein Thrombosis; Pulmonary Embolism
• Intervention / Treatment: Behavioral: Education

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Switzerland
  • Basel-Stadt
    • Basel, Basel-Stadt, Switzerland, 4056
      • University of Basel, Pharmaceutical Care Research Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients having a prescription for NOACs

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Education	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Number of patients having an anticoagulation identification card	assessed once at visit 1 (baseline assessment)

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: University of Basel
• Investigators: Study Chair: Kurt Hersberger, Prof., University of Basel; Principal Investigator: Isabelle Arnet, PD., Pharmaceutical Care Research Group, University of Base

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): July 30, 2017
• Study Completion (Actual): July 30, 2017

Study Registration Dates

• First Submitted: April 7, 2017
• First Submitted That Met QC Criteria: April 18, 2017
• First Posted (Actual): April 24, 2017

Study Record Updates

• Last Update Posted (Actual): August 3, 2017
• Last Update Submitted That Met QC Criteria: August 2, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Arrhythmias, Cardiac; Embolism; Atrial Fibrillation; Thrombosis; Venous Thrombosis; Pulmonary Embolism
• Other Study ID Numbers: NOAC-Validation-study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No