An interventional study of Specialized outpatient AF Clinic and Usual Care in Atrial Fibrillation, sponsored by Maastricht University Medical Center. Completed at 8 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-28.
Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Treatment
Rationale: The treatment of patients with atrial fibrillation is often inadequate due to poor guideline adherence. An integrated chronic care program (ICCP) at a specialized AF-clinic was found to be superior to usual care provided by a cardiologist in terms of cardiovascular hospitalizations and cardiovascular mortality.
Hypothesis: treatment at a specialized AF clinic is superior to usual care in terms of cardiovascular mortality and cardiovascular hospitalizations, cost-effectiveness, quality of life and guideline adherence.
Objectives: primary objective is to show that an ICCP reduces cardiovascular hospitalizations and mortality.
Study design: randomized controlled trial with two study arms: usual care provided by cardiologists (control) versus integrated chronic care program at a specialized AF clinic (intervention) in 8 hospitals in the Netherlands. The RACE4 is an event driven study. A total number of 246 events is needed. In total 1716 patients with newly diagnosed AF will be included. Total duration of the study is 5 years and 10 months with a minimal follow up of 1 year. Data is collected at inclusion, after 3, 6, 12 months, every year thereafter and at the end of the study.
Study population: Patients older than 18 year with newly diagnosed AF.
Intervention: The intervention is delivered through the specialized outpatient AF clinic. The multidisciplinary team at the AF clinic consists of a nurse practitioner or physician assistant or specialised cardiovascular nurse, cardiologist, and is guided by guidelines-based decision support software program based on the applicable ESC guideline recommendations. The use of a web-based patient centered management of patient's own medication (Medication manager TM) was optional. A standardized diagnostic, treatment and follow-up pathway was performed within the ICCP.
3,869 studies on the registry are indexed under Atrial Fibrillation; 923 are open to participants now.
This study's enrollment of 1,375 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.
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Exclusion Criteria:
Management of AF patients in specialized outpatient AF Clinics according to the principles of an integrated chronic care program (ICCP) performed by a nurse practitioner/ physician assistant/ specialised cardiovascular nurse, cardiologist, supported by an ICT decision support tool based on professional guidelines (CardioConsult AF®). The use of a web-based patient centered management of patient's own medication (Medication manager TM) was optional. A standardized diagnostic, treatment and follow-up pathway was performed within the ICCP. In addition, the intervention is based on identifying risk factors and potential problems in patients, and addressing needs through dynamic use of personalized education and adjustment of treatment.
Other: Specialized outpatient AF Clinic
Usual care provided by cardiologists at the regular outpatient clinic.
Other: Usual Care
The primary endpoint is a composite of unplanned admission to the hospital for any cardiovascular reason and cardiovascular death.
Time frame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months
All components of the primary endpoint
Time frame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months
All-cause mortality
Time frame: Minimum of 1 year and a maximum of 5 years and 10 months
Total number of unplanned all-cause hospitalizations
Time frame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months
Duration of unplanned all-cause hospitalizations
Time frame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months
Total number of unplanned cardiovascular hospitalizations
Time frame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months
Duration of unplanned cardiovascular hospitalizations
Time frame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months
Total number of unplanned hospitalizations related to atrial fibrillation
Time frame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months
Duration of unplanned hospitalizations related to atrial fibrillation
Time frame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months
Recurrent unplanned cardiovascular hospitalizations
Time frame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months
Costs and cost-effectiveness
Costs, Quality Adjusted Life Years (QALYs) and Cost-effectiveness (Incremental Cost-Effectiveness Ratio - ICER)
Time frame: baseline, 1 year, 2 years, 3 years
Implementation of care
The extent to which the comprehensive cardiovascular treatment is in accordance with the most recent ESC guidelines Management of Atrial Fibrillation, the HF guidelines of acute and chronic heart failure and the CVD prevention guidelines
Time frame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months
Patient Quality of life
General health-related QoL is measured by using the SF-36
Time frame: Baseline, 1 year, 2 years, 3 years
Patient Quality of life
Patient's perception of severity of arrhythmia-related symptoms is measured by using the AFSS
Time frame: Baseline, 1 year, 2 years, 3 years
Anxiety and/ or depression
HADS-NL
Time frame: Baseline, 1 year, 2 years, 3 years
Knowledge of AF
Netherlands Knowledge Scale on AF
Time frame: Baseline, 1 year, 2 years, 3 years
Compliance to medication
MMAS
Time frame: Baseline, 1 year, 2 years, 3 years
Compliance to medication
To measure the level of activation of a specific individual the PAM-13 Dutch is used
Time frame: Baseline, 1 year, 2 years, 3 years
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Maastricht University Medical Center