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

NCT03124654 | Completed

• 1 other identifier: NOAC-Validation-study
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Atrial Fibrillation; Pulmonary Embolism; Deep Vein Thrombosis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Patient's adherence assessed by questionnaire

  14 days

• Patient's satisfaction assessed by questionnaire

  14 days

• Patient's health literacy assessed by questionnaire

  assessed once at visit 1 (baseline assessment)

Other Outcomes (1)

• Number of patients having an anticoagulation identification card

  assessed once at visit 1 (baseline assessment)

Study Arms (1)

Education

Behavioral: Education

Interventions

Education BEHAVIORAL

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).

Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients having a prescription for NOACs

You may qualify if:

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

You may not qualify if:

• NOACs for orthopaedic indication
• Dementia in medical history

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• University of Basel: collaborator

Study Sites (1)

University of Basel, Pharmaceutical Care Research Group

Basel, Canton of Basel-City, 4056, Switzerland

Location

MeSH Terms

Conditions

Atrial Fibrillation; Pulmonary Embolism; Venous Thrombosis

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Thrombosis

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Kurt Hersberger, Prof.

  University of Basel

  STUDY CHAIR

• Isabelle Arnet, PD.

  Pharmaceutical Care Research Group, University of Base

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 24, 2017
• Study Start: September 1, 2016
• Primary Completion: July 30, 2017
• Study Completion: July 30, 2017
• Last Updated: August 3, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)