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Clinical Trials/NCT05773768
NCT05773768
Recruiting
Not Applicable

EHRA-PATHS: Addressing Multimorbidity in Elderly Atrial Fibrillation Patients Through Interdisciplinary, Patient-centred Systematic Care Pathways - Clinical and Health Economic Evaluation of New Care Pathways

University Medical Center Groningen1 site in 1 country1,300 target enrollmentMarch 28, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Fibrillation
Sponsor
University Medical Center Groningen
Enrollment
1300
Locations
1
Primary Endpoint
Identification and management of risk factors and comorbidities
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

In elderly atrial fibrillation (AF) patients, AF is usually a manifestation of risk factors and comorbidities not only limited to cardiovascular diseases. Especially in elderly often more than two comorbidities are present. The presence of comorbidities also affects outcomes in AF patients. Current healthcare systems are single-disease focused, which increases the risk of underdiagnosing, replicating diagnostic tests and adverse drug-drug interactions, placing a high burden on healthcare costs. Healthcare systems and hospitals are in need of new care pathways to address the complexity of multimorbid AF patients and to reduce costs. The EHRA-PATHS consortium set out to address this need for change in management for multimorbid, elderly AF patients in Europe through the development of new care pathways. The aim of this study is to evaluate the current management of risk factors and comorbidities, and subsequently implement the newly developed care pathways and evaluate if these pathways lead to better management of risk factors and comorbidities in multimorbid, elderly AF patients, compared to current standard care.

Registry
clinicaltrials.gov
Start Date
March 28, 2024
End Date
January 1, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed atrial fibrillation (paroxysmal, persistent or permanent)
  • ≥65 years of age
  • Willing and able to participate and to attend the scheduled follow-up visits.

Exclusion Criteria

  • Atrial fibrillation episode was due to a trigger (i.e. postoperative, infection, hyperthyroidism etc.)
  • Life expectancy of less than 1 year
  • Participation in another clinical study (registry studies not included)
  • Severe cognitive impairment / dementia (defined based on MMSE and CDR scoring systems)

Outcomes

Primary Outcomes

Identification and management of risk factors and comorbidities

Time Frame: 6 months

The number of risk factors and comorbidities that are identified and for which treatment is initiated during base mapping and at the end of the randomized controlled trial.

Secondary Outcomes

  • HRQoL/utility(6 months)
  • Referrals to other disciplines(6 months)
  • AF symptom burden(6 months)
  • Quality of life (QoL)(6 months)
  • Patient and health care provider satisfaction(6 months)
  • Healthcare resource use/costs(6 months)

Study Sites (1)

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