Outpatient cardiac rehabilitation. Part V: Study protocol "Multi-centre, prospective cohort study with two control groups (with/without phase III)"

Six- to twelve-month outpatient cardiac phase III rehabilitation following phase II is currently provided at a few sites in Austria. Eight outpatient cardiac rehabilitation centres of the working group on outpatient cardiac prevention and rehabilitation (AGAKAR) currently have temporary contracts with the Association of Austrian Health Insurance Providers (HVB). Based on international studies the effectiveness of cardiac rehabilitation seems to be proven in general. But there is a lack of studies on long-term effectiveness of (short) phase II programmes or on optional subsequent phase III compared to no further rehabilitative measures. There is at least limited evidence that effects (positive impact on cardiovascular risk factors), that have been achieved in phase II, are not sustainable. Phase III therefore aims at preventing aggravation of risk factors or even at a further improvement. The planned study is based upon numerous preliminary work of LBI-HTA (outpatient cardiac rehabilitation parts I to IV). Research question: The primary research question of the study is: Do patients with disadvantageous risk profile (at least three out of six risk factor categories out of the rehabilitation target area) who attend an additional phase III programme after phase II (+PhIII) have at mean less risk factors out of the target area compared to patients without phase III (-PhIII) 18 months after end of phase II? Study design: multi-centre, prospective cohort study with two control groups (with/ without phase III) Measures: +PhIII patients attend a phase III programme after they made their own decision to apply for it. -PhIII patients receive routine medical care (general practitioner, internal specialist) without attending a phase III programme. Procedural method: A total of 450 patients will be included at the end of phase II in six inpatient and eight outpatient rehabilitation centres during a nine month period. In addition to routinely assessed clinical parameters (e.g. blood pressure, lipids, glucose; BMI), that will be documented in a standardised way for the study purpose, a paper-based patient questionnaire will be handed out (including anxiety/depression, health related quality of life). The application for phase III for +PhIII-patients will be made in the phase II centre. 18 month after the end of phase II (end of the individual observation period) all patients will receive a patient questionnaire again as well as a doctor´s questionnaire. This questionnaire (current clinical parameters including laboratory and ergometry results similar to the baseline examination and meantime cardiovascular events) will be filled in by the internal specialist of each patient (alternative by an internal specialist of an outpatient clinic owned by sickness funds) during a visit routinely carried out for patients at elevated cardiovascular risk. The total study duration, starting with inclusion of the first patient and ending with the final report, will be approximately three years.