Atrial Fibrillation
Conditions
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.
Interventions
DEVICEEHRA-PATHS software tool
Newly developed care pathways integrated into a care-management software tool
Sponsors
University Medical Center Groningen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification and management of risk factors and comorbidities | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (QoL) | 6 months | Measured with the EuroQol five-dimensional five-level (EQ-5D-5L) questionnaire |
| Referrals to other disciplines | 6 months | The referrals to other disciplines will consist of the number of referrals and the percentage of patients referred. |
| AF symptom burden | 6 months | Measured with the Atrial Fibrillation Severity Scale (AFSS) questionnaire |
| Healthcare resource use/costs | 6 months | Measured with the iMedical Consumption Questionnaire (iMCQ) |
| HRQoL/utility | 6 months | Measured with the EQ-5D-5L questionnaire (iMCQ) |
| Patient and health care provider satisfaction | 6 months | Measured with a patient and health care provider (HCP) satisfaction questionnaire |
Countries
Netherlands
Outcome results
None listed