IntegRAted Chronic Care Program at Specialized AF Clinic Versus Usual CarE in Patients With Atrial Fibrillation - RACE4

Atrial Fibrillation Clinical Trial

— RACE4  

Official title:

IntegRAted Chronic Care Program at a Specialized Atrial Fibrillation (AF) Clinic Versus Usual CarE in Patients With Atrial Fibrillation, an Investigator-initiated, Prospective, Randomised, Open Label, Blinded Outcome Assessment (PROBE) Controlled Multi-center Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01740037
• Other study ID #: METC 11-2-099
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: September 30, 2018

Study information

• Verified date: April 2019
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1375
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with newly diagnosed AF detected on electrocardiogram (ECG), holter recordings or event recorder with a duration > 30 seconds, 3 months before inclusion or

2. Patients with a history of diagnosed AF, with no regular control at a cardiologist for AF in the last 2 years and referred by a (non-)cardiologic medical specialist for new diagnostics or therapeutic issue;

3. Age =18 years.

Exclusion Criteria:

1. No electrocardiographic objectified AF;

2. Unstable heart failure defined as NYHA IV or heart failure necessitating hospital admission < 3 months before inclusion;

3. Acute coronary syndrome (acute myocardial infarction or instable angina pectoris, with two of the following characteristics: chest pain and/ or ischemic electrocardiographic changes, and/ or cardiac enzyme rise) < 3 months before inclusion;

4. Untreated hyperthyroidism or < 3 months euthyroidism before inclusion;

5. Foreseen pacemaker, internal cardioverter defibrillator, and/ or cardiac resynchronization therapy;

6. Cardiac surgery = 3 months before inclusion;

7. Planned cardiac surgery;

8. Regular control and treatment, also for AF, at another specialized outpatient cardiac clinic;

9. Patient is not able to fill in the questionnaires;

10. Participation in other clinical study.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• Specialized outpatient AF Clinic

• Usual Care

Locations

Country	Name	City	State
Netherlands	Martini Ziekenhuis	Groningen
Netherlands	UMCG	Groningen
Netherlands	Spaarne Gasthuis	Haarlem
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden
Netherlands	MUMC+	Maastricht
Netherlands	Canisius Wilhelmina Ziekenhuis Nijmegen	Nijmegen
Netherlands	Zaans Medisch Centrum	Zaandam
Netherlands	Isala	Zwolle

Sponsors (9)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, CZ Fonds, Daiichi Sankyo, Inc., DSW, Pfizer, Stichting Achmea Gezondheidszor

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is a composite of unplanned admission to the hospital for any cardiovascular reason and cardiovascular death.		Follow up with minimum of 1 year and a maximum of 5 years and 10 months
Secondary	All components of the primary endpoint		Follow up with minimum of 1 year and a maximum of 5 years and 10 months
Secondary	All-cause mortality		Minimum of 1 year and a maximum of 5 years and 10 months
Secondary	Total number of unplanned all-cause hospitalizations		Follow up with minimum of 1 year and a maximum of 5 years and 10 months
Secondary	Duration of unplanned all-cause hospitalizations		Follow up with minimum of 1 year and a maximum of 5 years and 10 months
Secondary	Total number of unplanned cardiovascular hospitalizations		Follow up with minimum of 1 year and a maximum of 5 years and 10 months
Secondary	Duration of unplanned cardiovascular hospitalizations		Follow up with minimum of 1 year and a maximum of 5 years and 10 months
Secondary	Total number of unplanned hospitalizations related to atrial fibrillation		Follow up with minimum of 1 year and a maximum of 5 years and 10 months
Secondary	Duration of unplanned hospitalizations related to atrial fibrillation		Follow up with minimum of 1 year and a maximum of 5 years and 10 months
Secondary	Recurrent unplanned cardiovascular hospitalizations		Follow up with minimum of 1 year and a maximum of 5 years and 10 months
Secondary	Costs and cost-effectiveness	Costs, Quality Adjusted Life Years (QALYs) and Cost-effectiveness (Incremental Cost-Effectiveness Ratio - ICER)	baseline, 1 year, 2 years, 3 years
Secondary	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	Follow up with minimum of 1 year and a maximum of 5 years and 10 months
Secondary	Patient Quality of life	General health-related QoL is measured by using the SF-36	Baseline, 1 year, 2 years, 3 years
Secondary	Patient Quality of life	Patient's perception of severity of arrhythmia-related symptoms is measured by using the AFSS	Baseline, 1 year, 2 years, 3 years
Secondary	Anxiety and/ or depression	HADS-NL	Baseline, 1 year, 2 years, 3 years
Secondary	Knowledge of AF	Netherlands Knowledge Scale on AF	Baseline, 1 year, 2 years, 3 years
Secondary	Compliance to medication	MMAS	Baseline, 1 year, 2 years, 3 years
Secondary	Compliance to medication	To measure the level of activation of a specific individual the PAM-13 Dutch is used	Baseline, 1 year, 2 years, 3 years