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Completed

NCT Number: NCT03124654

Development of a Questionnaire to Assess Patient Knowledge About 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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Deep Vein Thrombosis Embolism Embolism and Thrombosis Heart Diseases Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Embolism Respiratory Tract Diseases Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Basel, Pharmaceutical Care Research Group

Basel, Canton of Basel-City, 4056, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Validation of the new questionnaire assessed by questionnaire

    Time frame: 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.

  2. Sensitivity of the new questionnaire

    Time frame: 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)

  3. Test retest validity of the new questionnaire

    Time frame: 7 days

    Number of correct/incorrect answers measured at visit 1 and 2 (0 respectively 7 days after visit 1)

Secondary outcomes

  1. Patient's adherence assessed by questionnaire

    Time frame: 14 days

    change in adherence between visits 1 (baseline) and visit 3

  2. Patient's satisfaction assessed by questionnaire

    Time frame: 14 days

    change in satisfaction between visits 1 (baseline) and visit 3

  3. Patient's health literacy assessed by questionnaire

    Time frame: assessed once at visit 1 (baseline assessment)

Other outcomes

  1. Number of patients having an anticoagulation identification card

    Time frame: assessed once at visit 1 (baseline assessment)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • University of Basel

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 24, 2017
Registry last updated
Aug 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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