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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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.

France1 site
  • CHU de Bordeaux

    Pessac, 33604

Other trials in France

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.

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 groups in NCT03645564
Study groupRoleWhat they receive
Group 1 : specialized nurse consultationActive comparatorThis 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 consultationNo interventionThis 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.

  1. Adherence to direct oral anticoagulants

    Adherence questionnaire

    Measured: 12 months

Secondary outcomes (1)
  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.

  1. First posted24 Aug 2018
  2. Study start16 Oct 2018
  3. Primary completion13 Jun 2022
  4. Study completion13 Jun 2022

Why it stopped: Recruitment incomplete due to COVID

Resources

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)
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

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