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NCT Number: NCT05773768

EHRA-PATHS: Clinical and Health Economic Evaluation of New Care Pathways

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Groningen

Groningen, Netherlands

Location status: Recruiting

Location contact

Bart A Mulder, MD/PhD

CONTACT

[email protected]

0655257399

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

EHRA-PATHS software tool

Device

Newly developed care pathways integrated into a care-management software tool

Primary outcomes

  1. 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

  1. AF symptom burden

    Time frame: 6 months

    Measured with the Atrial Fibrillation Severity Scale (AFSS) questionnaire

  2. Quality of life (QoL)

    Time frame: 6 months

    Measured with the EuroQol five-dimensional five-level (EQ-5D-5L) questionnaire

  3. Referrals to other disciplines

    Time frame: 6 months

    The referrals to other disciplines will consist of the number of referrals and the percentage of patients referred.

  4. Patient and health care provider satisfaction

    Time frame: 6 months

    Measured with a patient and health care provider (HCP) satisfaction questionnaire

  5. Healthcare resource use/costs

    Time frame: 6 months

    Measured with the iMedical Consumption Questionnaire (iMCQ)

  6. HRQoL/utility

    Time frame: 6 months

    Measured with the EQ-5D-5L questionnaire (iMCQ)

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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

Acronym: EHRA-PATHS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 17, 2023
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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