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Reaching the Frail Elderly for the Management of Atrial Fibrillation (REAFEL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04162548
Recruitment Status : Recruiting
First Posted : November 14, 2019
Last Update Posted : July 10, 2020
Information provided by (Responsible Party):
Helena DOMINGUEZ, University Hospital Bispebjerg and Frederiksberg

Brief Summary:

The overall objective of the project is to develop a collaboration model between the patient, the patient's General Practitioner (GP) and the cardiologist at the hospital in a seamless collaborative model dubbed the "Cardio-relay model".

The specific purpose of the pilot project is to ease performing heart rhythm monitoring with focus on diagnosis and evaluation of atrial fibrillation (AF), for patients who have difficulties to attend repeated visits to the hospital-based outpatient clinic.

With available eHealth technologies the cardiologist can access data gathered at the patient's side to provide support to the GP for selecting patients with need for heart rhythm monitoring, plan further evaluations and guide therapeutic decisions. These patients can thereby receive support that without the burden of attending physical meetings at the cardiologist office. The investigators evaluate if the cardio-relay model allows to complete evaluation of frail patients compared to usual care and if patients experience are sufficiently confident accessing the cardiologist through the cardio-relay model.

Condition or disease
Atrial Fibrillation

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Reaching the Frail Elderly for the Management of Atrial Fibrillation
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


"Cardio-relay" is a novel collaboration model between hospital-based specialists and primary care, to provide high-quality care to frail patients, relieving their burden to attend multiple hospital specialist visits.

Using telemedicine, it is possible to make measurements where the patient is (at the family clinic at the patient's home). Data are available for all the involved. That is, primary the patient, the relatives and caregivers that the patient wishes help from and health professionals from the family clinics and the hospital. Thereby, the hospital-based specialist supports the family clinic with expert knowledge, the need for attending the hospital facilities reduced to focus on what is strictly needed as specialized provider. Ultimately, the patient can be reached for high-quality care, relieving the patient's burden to attend multiple hospital specialist visits.

Primary Outcome Measures :
  1. Time to diagnosis conclusion [ Time Frame: six months follow-up ]
    Completion of evaluation for definite or rule-out diagnosis within six weeks in 90% of patients included in the intervention arm compared to 70% within six weeks

Secondary Outcome Measures :
  1. Identification of population that benefits with the cardio-relay model [ Time Frame: six months follow-up ]
    patient satisfaction measured with focused interviews

Other Outcome Measures:
  1. Number of referrals [ Time Frame: six months follow-up ]
    Explorative analysis on number of referrals to the cardiology outpatient clinic

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

"Frail elderly" are aged ≥ 65 years and have at least one of the following impairments:

  • Transportation: Need for help to get to hospital outpatient departments
  • Personal care: Need for help in personal hygiene
  • Walking impairment: Reduced ability to walk (takes more than 5 sec. for the patient to walk 5 metres)
  • Weight loss: Unintentional weight loss within the past year
  • Cognitive difficulties: dementia, memory problems, aphasia, etc.
  • Social problems: due to alcohol abuse or other abuse, ethnic background, language, etc.

Inclusion Criteria:

- "Frail elderly" are aged ≥ 65 years

Exclusion Criteria:

  • Not willingness to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04162548

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Contact: Helena DOMINGUEZ, MD, PhD +4538166068
Contact: Anne Frølich, Professor +4527121622

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Cardiology department Y, Bispebjerg-Frederiksberg Hospital Recruiting
Frederiksberg, Denmark, 2000
Contact: Helena Dominguez, MD, PhD    +4538163916 ext 6068   
Contact: Christoffer V Madsen, MD    +4520661178   
Sponsors and Collaborators
University Hospital Bispebjerg and Frederiksberg
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Study Chair: Helena DOMINGUEZ, MD, PhD Frederiksberg hospital
Publications of Results:

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Responsible Party: Helena DOMINGUEZ, MD, PhD, Associate Professor, University Hospital Bispebjerg and Frederiksberg Identifier: NCT04162548    
Other Study ID Numbers: H-18052892
First Posted: November 14, 2019    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Helena DOMINGUEZ, University Hospital Bispebjerg and Frederiksberg:
public health
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes