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Atrial FibrillationRACE4NCT01740037

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

A study testing Specialized outpatient AF Clinic in people with Atrial Fibrillation, run by Maastricht University Medical Center at 8 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Specialized outpatient AF Clinic
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,375 participants
Where
8 sitesNetherlands
Study dates
Dec 2012to 30 Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with newly diagnosed AF detected on electrocardiogram (ECG), holter recordings or event recorder with a duration > 30 seconds, 3 months before inclusion or
  • 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;
  • Age ≥18 years.

Who cannot join

  • No electrocardiographic objectified AF;
  • Unstable heart failure defined as NYHA IV or heart failure necessitating hospital admission < 3 months before inclusion;
  • 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;
  • Untreated hyperthyroidism or < 3 months euthyroidism before inclusion;
  • Foreseen pacemaker, internal cardioverter defibrillator, and/ or cardiac resynchronization therapy;
  • Cardiac surgery ≤ 3 months before inclusion;
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  • Planned cardiac surgery;
  • Regular control and treatment, also for AF, at another specialized outpatient cardiac clinic;
  • Patient is not able to fill in the questionnaires;
  • Participation in other clinical study.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Netherlands8 sites

  • Martini Ziekenhuis

    Groningen

  • UMCG

    Groningen

  • Spaarne Gasthuis

    Haarlem

  • Medisch Centrum Leeuwarden

    Leeuwarden

  • MUMC+

    Maastricht

  • Canisius Wilhelmina Ziekenhuis Nijmegen

    Nijmegen

  • Zaans Medisch Centrum

    Zaandam

  • Isala

    Zwolle

Other trials in Netherlands

About this study

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

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.

Read more

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.

Being tested
Specialized outpatient AF Clinic, Usual Care
Keywords
Integrated chronic care program, specialized outpatient AF clinic, Atrial Fibrillation guideline
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Specialized outpatient AF ClinicOther

  • Usual CareOther

Study groups in NCT01740037
Study groupRoleWhat they receive
Specialized AF-clinicExperimentalManagement 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.
Receives: Other: Specialized outpatient AF Clinic
Usual CareActive comparatorUsual care provided by cardiologists at the regular outpatient clinic.
Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary endpoint is a composite of unplanned admission to the hospital for any cardiovascular reason and cardiovascular death.

    Measured: Follow up with minimum of 1 year and a maximum of 5 years and 10 months

Secondary outcomes (17)

  1. All components of the primary endpoint

    Measured: Follow up with minimum of 1 year and a maximum of 5 years and 10 months

  2. All-cause mortality

    Measured: Minimum of 1 year and a maximum of 5 years and 10 months

  3. Total number of unplanned all-cause hospitalizations

    Measured: Follow up with minimum of 1 year and a maximum of 5 years and 10 months

  4. Duration of unplanned all-cause hospitalizations

    Measured: Follow up with minimum of 1 year and a maximum of 5 years and 10 months

  5. Total number of unplanned cardiovascular hospitalizations

    Measured: Follow up with minimum of 1 year and a maximum of 5 years and 10 months

  6. Duration of unplanned cardiovascular hospitalizations

    Measured: Follow up with minimum of 1 year and a maximum of 5 years and 10 months

  7. Total number of unplanned hospitalizations related to atrial fibrillation

    Measured: Follow up with minimum of 1 year and a maximum of 5 years and 10 months

  8. Duration of unplanned hospitalizations related to atrial fibrillation

    Measured: Follow up with minimum of 1 year and a maximum of 5 years and 10 months

  9. Recurrent unplanned cardiovascular hospitalizations

    Measured: Follow up with minimum of 1 year and a maximum of 5 years and 10 months

  10. Costs and cost-effectiveness

    Costs, Quality Adjusted Life Years (QALYs) and Cost-effectiveness (Incremental Cost-Effectiveness Ratio - ICER)

    Measured: baseline, 1 year, 2 years, 3 years

  11. 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

    Measured: Follow up with minimum of 1 year and a maximum of 5 years and 10 months

  12. Patient Quality of life

    General health-related QoL is measured by using the SF-36

    Measured: Baseline, 1 year, 2 years, 3 years

  13. Patient Quality of life

    Patient's perception of severity of arrhythmia-related symptoms is measured by using the AFSS

    Measured: Baseline, 1 year, 2 years, 3 years

  14. Anxiety and/ or depression

    HADS-NL

    Measured: Baseline, 1 year, 2 years, 3 years

  15. Knowledge of AF

    Netherlands Knowledge Scale on AF

    Measured: Baseline, 1 year, 2 years, 3 years

  16. Compliance to medication

    MMAS

    Measured: Baseline, 1 year, 2 years, 3 years

  17. Compliance to medication

    To measure the level of activation of a specific individual the PAM-13 Dutch is used

    Measured: Baseline, 1 year, 2 years, 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2012 (estimated)
  2. Study startDec 2012
  3. Primary completion30 Sep 2018
  4. Study completion30 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,375 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01740037
Sponsor's protocol ID
METC 11-2-099
Acronym
RACE4
Status last verified
Apr 2019
First submitted
16 Oct 2012
Last updated
28 May 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Wijtvliet EPJP, Tieleman RG, van Gelder IC, Pluymaekers NAHA, Rienstra M, Folkeringa RJ, Bronzwaer P, Elvan A, Elders J, Tukkie R, Luermans JGLM, Van Asselt ADIT, Van Kuijk SMJ, Tijssen JG, Crijns HJGM; RACE 4 Investigators. Nurse-led vs. usual-care for atrial fibrillation. Eur Heart J. 2020 Feb 1;41(5):634-641. doi: 10.1093/eurheartj/ehz666.

    PubMed 31544925

Questions about this trial

What is this clinical trial studying?

A study testing Specialized outpatient AF Clinic in people with Atrial Fibrillation, run by Maastricht University Medical Center at 8 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01740037, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2019.

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