Atrial FibrillationNCT03124654
Development of a Questionnaire to Assess Patient Knowledge About Non-vitamin K Anticoagulants (NOAC)
An observational study of Atrial Fibrillation and Pulmonary Embolism, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Pulmonary Embolism, Deep Vein Thrombosis
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2016to 30 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients having a prescription for NOACs
Who may be able to join
- Intake of a NOACs (Rivaroxaban, Edoxaban, Dabigatran, Apixaban)
- ≥18 years
- Able to give written Informed consent in German
Who cannot join
- NOACs for orthopaedic indication
- Dementia in medical history
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Basel, Pharmaceutical Care Research Group
Basel, Canton of Basel-City, 4056
About this study
Official title: 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
- Being tested
- Education
- Medical subject headings
- Atrial Fibrillation, Pulmonary Embolism, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Education | Not described Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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)
Measured: 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)
Measured: 7 days
Secondary outcomes (3)
Patient's adherence assessed by questionnaire
change in adherence between visits 1 (baseline) and visit 3
Measured: 14 days
Patient's satisfaction assessed by questionnaire
change in satisfaction between visits 1 (baseline) and visit 3
Measured: 14 days
Patient's health literacy assessed by questionnaire
Measured: assessed once at visit 1 (baseline assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start1 Sep 2016
- Primary completion30 Jul 2017
- Study completion30 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Basel
- Responsible party
- Sponsor
- Investigators
- Kurt Hersberger, Prof., Study chair, University of BaselIsabelle Arnet, PD., Principal investigator, Pharmaceutical Care Research Group, University of Base
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03124654
- Sponsor's protocol ID
- NOAC-Validation-study
- Status last verified
- Aug 2017
- First submitted
- 7 Apr 2017
- Last updated
- 3 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Novel Educational Program for Patients Prescribed Non-vitamin K Anticoagulants (NOAC)
- ClinicalTrials.gov ID
- NCT03124654
- Acronym / sponsor ID
- NOAC-Validation-study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University of Basel
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 30 Jul 2017 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Education | – | Behavioral: Education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having a prescription for NOACs
Key inclusion criteria (3 listed)
- Intake of a NOACs (Rivaroxaban, Edoxaban, Dabigatran, Apixaban)
- ≥18 years
- Able to give written Informed consent in German
Key exclusion criteria (2 listed)
- NOACs for orthopaedic indication
- Dementia in medical history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationPatients 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). | Behavioural | Education |
Primary outcome
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.
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)
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)
3 secondary outcomes
Patient's adherence assessed by questionnaire
Time frame: 14 days
Patient's satisfaction assessed by questionnaire
Time frame: 14 days
Patient's health literacy assessed by questionnaire
Time frame: assessed once at visit 1 (baseline assessment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kurt Hersberger, Prof. study chair
University of Basel
Isabelle Arnet, PD. principal investigator
Pharmaceutical Care Research Group, University of Base
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Pulmonary Embolism, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of the new questionnaire assessed by questionnaire (time frame: measured once at visit 1 (baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2017; AzTrials last refreshed its copy on 1 Nov 2026.