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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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03124654
Enrollment
60
Registered
2017-04-24
Start date
2016-09-01
Completion date
2017-07-30
Last updated
2017-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Deep Vein Thrombosis, Pulmonary Embolism

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

Interventions

BEHAVIORALEducation

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).

Sponsors

University of Basel
CollaboratorOTHER
University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Test retest validity of the new questionnaire7 daysNumber of correct/incorrect answers measured at visit 1 and 2 (0 respectively 7 days after visit 1)
Validation of the new questionnaire assessed by questionnairemeasured 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 questionnaire7 days after visit 1, before and after the educational programNumber of correct/incorrect answers measured at visit 2 before and after the educational program has been dispensed (7 days after visit 1)

Secondary

MeasureTime frameDescription
Patient's satisfaction assessed by questionnaire14 dayschange in satisfaction between visits 1 (baseline) and visit 3
Patient's health literacy assessed by questionnaireassessed once at visit 1 (baseline assessment)
Patient's adherence assessed by questionnaire14 dayschange in adherence between visits 1 (baseline) and visit 3

Other

MeasureTime frame
Number of patients having an anticoagulation identification cardassessed once at visit 1 (baseline assessment)

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026