Atrial FibrillationRYTHM-UP AODNCT03645564
Impact of the Information Follow-up Given to Patients on Their Disease Understanding and Therapeutic Adherence in Patients Under Direct Oral Anticoagulants and With Atrial Fibrillation in a Cardiology Department
A study testing Specialized nurse consultation in people with Atrial Fibrillation, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The primary objective of this study is to measure in patients addressed for Atrial Fibrillation (AF) in the Cardiology-Electrophysiology and Cardiac Stimulation Department of Bordeaux hospital, the impact of a specialized nurse consultation on their adherence level to direct oral anticoagulants treatments. Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Specialized nurse consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2018to 13 Jun 2022
- Phase
- Interventional
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 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient hospitalized in the Cardiology-Electrophysiology and Cardiac Stimulation Department for an AF,
- Patient requiring direct oral anticoagulant treatment,
- Age ≥ 18 years of both genders,
- Written consent,
- Patient affiliated or beneficiary of a social insurance,
- French language.
Who cannot join
- Patient unable to give his written consent or with cognitive disorders,
- Patient depending of a third person,
- Patient unable to be followed in the service,
- Patient in exclusion period for another protocol,
- Subject deprived of liberty by judicial or administrative decision,
- Protected adults,
- Non-inclusion criteria specific to direct oral anticoagulants (valvular AF, severe renal impairment).
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to measure in patients addressed for Atrial Fibrillation (AF) in the Cardiology-Electrophysiology and Cardiac Stimulation Department of Bordeaux hospital, the impact of a specialized nurse consultation on their adherence level to direct oral anticoagulants treatments.
Read the detailed description
The number of persons that should take an anticoagulant treatment in France is evaluated at 3 Billion and at least half of them for an Atrial Fibrillation disease. One of the main issues of their prescription is stoke prevention. With the coming of direct oral anticoagulants, which does not require repeating controls like it is the case for anti-vitamin K treatments, the patient's involvement is a guarantee of therapeutic adherence and good use. Nevertheless a good adherence level is seldom reached. This highlights the importance of individualized information which must be followed for purposes of accuracy and deepening. Thus as part of investigator's activity department that treats about 1000 patients per year for an Atrial Fibrillation, the information, use and therapeutic adherence are a priority in the care pathway of patients under direct oral anticoagulants. The investigators propose to measure the contribution of a specialized nurse consultation in contact with a multidisciplinary team on therapeutic adherence. The investigators hypothesis that an individualized and reassessed information would allowed a better understanding by the patients of their pathology and care and thus a better therapeutic adherence. A control group will present the same care pathway than all the patients of the service suffering from Atrial Fibrillation without specialized nurse consultation. The second group will benefit of a specialized nurse consultation throughout of which an individualized information will be delivered. This information will be reevaluated during the usual patient follow-up. All the patients will be followed at 3 months, 6 months and 1 year as part of the usual care of the service.
- Conditions
- Atrial Fibrillation
- Being tested
- Specialized nurse consultation
- Keywords
- Stroke, Anti-vitamin K, Direct anti-coagulant, Nurse
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specialized nurse consultationOther
The purpose of this consultation is to establish a partnership between the patient and the nursing staff. Tools were set up (notebook, movie) to answer the questions of the patient. In case of specific question, an expert will meet the patient (doctor of the service, psychologist, pharmacist or hematologist).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : specialized nurse consultation | Active comparator | This group will benefit of a specialized nurse consultation throughout of which an individualized information will be delivered. This information will be reevaluated during the usual patient follow-up. Receives: Other: Specialized nurse consultation |
| Group 2 : no specialized nurse consultation | No intervention | This control group will present the same care pathway than all the patients of the service suffering from Atrial Fibrillation without specialized nurse consultation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to direct oral anticoagulants
Adherence questionnaire
Measured: 12 months
Secondary outcomes (1)
Change in the level of knowledge of disease and treatment
Assessment by auto-questionnaire
Measured: Change from baseline at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start16 Oct 2018
- Primary completion13 Jun 2022
- Study completion13 Jun 2022
Why it stopped: Recruitment incomplete due to COVID
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is an open, prospective, randomized, 2 arms study that will compare 2 groups of patients care for Atrial Fibrillation in the Cardiology-Electrophysiology and Cardiac Stimulation Department with direct oral anticoagulants prescription.
- Masking
- None (open label)
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélie PETIT-MONEGER, MD, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645564
- Sponsor's protocol ID
- CHUBX 2016/43
- Acronym
- RYTHM-UP AOD
- Status last verified
- Feb 2024
- First submitted
- 20 Aug 2018
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No