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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 (RYTHM-UP AOD)

Primary Purpose

Atrial Fibrillation

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Specialized nurse consultation
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Atrial Fibrillation focused on measuring Stroke, Anti-vitamin K, Direct anti-coagulant, Nurse

Eligibility Criteria

18 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Sites / Locations

  • CHU de Bordeaux

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Group 1 : specialized nurse consultation

Group 2 : no specialized nurse consultation

Arm Description

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.

This control group will present the same care pathway than all the patients of the service suffering from Atrial Fibrillation without specialized nurse consultation.

Outcomes

Primary Outcome Measures

Adherence to direct oral anticoagulants
Adherence questionnaire

Secondary Outcome Measures

Change in the level of knowledge of disease and treatment
Assessment by auto-questionnaire

Full Information

First Posted
August 20, 2018
Last Updated
February 9, 2022
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT03645564
Brief Title
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
Acronym
RYTHM-UP AOD
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 16, 2018 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Stroke, Anti-vitamin K, Direct anti-coagulant, Nurse

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
221 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 : specialized nurse consultation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 2 : no specialized nurse consultation
Arm Type
No Intervention
Arm Description
This control group will present the same care pathway than all the patients of the service suffering from Atrial Fibrillation without specialized nurse consultation.
Intervention Type
Other
Intervention Name(s)
Specialized nurse consultation
Intervention Description
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).
Primary Outcome Measure Information:
Title
Adherence to direct oral anticoagulants
Description
Adherence questionnaire
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in the level of knowledge of disease and treatment
Description
Assessment by auto-questionnaire
Time Frame
Change from baseline at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurélie PETIT-MONEGER, MD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Study Chair
Facility Information:
Facility Name
CHU de Bordeaux
City
Pessac
ZIP/Postal Code
33604
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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