Reaching the Frail Elderly for the Management of Atrial Fibrillation

NCT04162548 | Completed DMC

• 1 other identifier: H-18052892
• Study Type: observational
• Target: 344
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

frail; public health

Outcome Measures

Primary Outcomes (1)

• Time to diagnosis conclusion

  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

  six months follow-up

Secondary Outcomes (1)

• Identification of population that benefits with the cardio-relay model

  six months follow-up

Other Outcomes (1)

• Number of referrals

  six months follow-up

Study Arms (1)

cardio-relay

"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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients referred from primary care to assess atrial fibrillation diagnosis and burden "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.

You may qualify if:

• "Frail elderly" are aged ≥ 65 years
• Non-frail adults (\> 18 years old)

You may not qualify if:

• Not willingness to participate

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead

Study Sites (1)

Cardiology department Y, Bispebjerg-Frederiksberg Hospital

Frederiksberg, 2000, Denmark

Location

Related Publications (7)

• Bavelloni A, Piazzi M, Raffini M, Faenza I, Blalock WL. Prohibitin 2: At a communications crossroads. IUBMB Life. 2015 Apr;67(4):239-54. doi: 10.1002/iub.1366. Epub 2015 Apr 21.

  PMID: 25904163 RESULT

• Kayser L, Karnoe A, Furstrand D, Batterham R, Christensen KB, Elsworth G, Osborne RH. A Multidimensional Tool Based on the eHealth Literacy Framework: Development and Initial Validity Testing of the eHealth Literacy Questionnaire (eHLQ). J Med Internet Res. 2018 Feb 12;20(2):e36. doi: 10.2196/jmir.8371.

  PMID: 29434011 RESULT

• Osborne RH, Elsworth GR, Whitfield K. The Health Education Impact Questionnaire (heiQ): an outcomes and evaluation measure for patient education and self-management interventions for people with chronic conditions. Patient Educ Couns. 2007 May;66(2):192-201. doi: 10.1016/j.pec.2006.12.002. Epub 2007 Feb 22.

  PMID: 17320338 RESULT

• Osborne RH, Batterham RW, Elsworth GR, Hawkins M, Buchbinder R. The grounded psychometric development and initial validation of the Health Literacy Questionnaire (HLQ). BMC Public Health. 2013 Jul 16;13:658. doi: 10.1186/1471-2458-13-658.

  PMID: 23855504 RESULT

• Barbour RS. Checklists for improving rigour in qualitative research: a case of the tail wagging the dog? BMJ. 2001 May 5;322(7294):1115-7. doi: 10.1136/bmj.322.7294.1115. No abstract available.

  PMID: 11337448 RESULT

• Schiotz ML, Host D, Frolich A. Involving patients with multimorbidity in service planning: perspectives on continuity and care coordination. J Comorb. 2016 Sep 16;6(2):95-102. doi: 10.15256/joc.2016.6.81. eCollection 2016.

  PMID: 29090180 RESULT

• Rutter D, Manley C, Weaver T, Crawford MJ, Fulop N. Patients or partners? Case studies of user involvement in the planning and delivery of adult mental health services in London. Soc Sci Med. 2004 May;58(10):1973-84. doi: 10.1016/S0277-9536(03)00401-5.

  PMID: 15020013 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Helena DOMINGUEZ, MD, PhD

  Frederiksberg hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Associate Professor

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 14, 2019
• Study Start: March 1, 2020
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: April 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)