The aim of this study is to evaluate current management, implement new care pathways and evaluate if this leads to improved identification of risk factors and comorbidities and treatment initiation in multimorbid, elderly AF patients as compared to…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Objective
To evaluate the management (assessment and treatment) of comorbidities in
patients newly diagnosed with AF (Part 1) and to assess whether systematic
implementation of new care pathways, including an easy-to-use software tool,
improves the identification of AF associated risk factors and comorbidities and
increases treatment initiation in elderly patients newly diagnosed with AF
(Part 2).
Secondary outcome
Secondary Objective(s)
To evaluate possible differences between the intervention and control group in
terms of:
• AF symptom burden
• Quality of life
• Referrals to other disciplines
• Patient and HCP satisfaction
• Cost-utility analysis
Background summary
The EHRA-PATHS consortium set out to address the need for change in management
for multimorbid, elderly AF patients in Europe. The project aims to transform
the current single-disease-focused pathway to holistic, inclusive and
personalized treatment pathways, with the purpose of reducing personal,
societal and economic burden compared to current standard of care. In order to
do this, the consortium has characterized multimorbidity in elderly AF patients
through databases and identified unmet needs within current clinical practice.
Based on this information, new AF care pathways have been developed.
Study objective
The aim of this study is to evaluate current management, implement new care
pathways and evaluate if this leads to improved identification of risk factors
and comorbidities and treatment initiation in multimorbid, elderly AF patients
as compared to current standard care.
Study design
The study consist of two parts;
• Part 1 - Observational (base mapping)
• Part 2 - Prospective, multicenter, international cluster randomized
controlled trial
Patients will be included in Part 1 of the study, in which the current practice
in the selected centres is observed; this will serve as base mapping of the
current clinical practice.
Before the start of Part 2, centres randomized to the intervention group will
receive dedicated training, either online or on-site. They also will have a
run-in period to get acquainted with the EHRA-PATHS* new software tool. New AF
patients in an intervention centre will receive a dedicated and personalized
*risk factors and comorbidities evaluation and management plan*. The newly
developed software tool will assist HCPs in providing this care.
Intervention
EHRA-PATHS* newly developed care pathways implemented in a software tool (Part
2).
Study burden and risks
Study participants will have three study visits in both study arms. Each visit
is expected to take 40 minutes. The first visit will take place in Part 1 and
will consist of base mapping. Information on comorbidities and risk factors
will be collected, depending on the current practice. In Part 2, the centres
will be randomized to either intervention or control. Another two visits will
take place during this part, in which the intervention group will follow the
EHRA-PATHS* care pathways and the control group will continue the current local
practice. In addition, questionnaires will be taken around the second and last
visit in both groups. Extra visits are allowed in both groups, if deemed
necessary by the HCP in order to optimize AF and/or comorbidity management. No
harm is expected for this study as the intervention will be based on
international guidelines. All patients will at least receive the standard care.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
* Newly diagnosed AF (paroxysmal, persistent or permanent)
* >=65 years of age
* Willing and able to participate and to attend the scheduled follow-up visits.
Exclusion criteria
* AF 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05773768 |
| CCMO | NL83890.042.23 |