SwissPR: Swiss Secondary Prevention and Rehabilitation Registry

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Recruiting

CT.gov ID

NCT05500859

Collaborator

(none)

4,000

Enrollment

Location

191.4

Anticipated Duration (Months)

20.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The SwissPR study is to continuously monitor patient characteristics and short- and long-term benchmark quality measures and outcomes of patients participating in a 12-week ambulatory CR program.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases (CVD)	Other: Data collection at Baseline, 3 months after baseline (BL), 1-year follow-up, Telephone follow-up and questionnaire 3 years and 5 years after BL

Detailed Description

The SwissPR study is a non-interventional, longitudinal observational cohort study consisting of a retrospective and a prospective part of patients who have completed the Cardiac Rehabilitation (CR) program of the University Hospital Basel. Assessing the impact of a CR program on key cardiovascular Benchmark Performance Measures (BPM) and its persistence over time would be helpful on internal quality control as well as identification of special need patients with highest cardiovascular risk. "KARAMBA" is the outpatient cardiovascular prevention and rehabilitation program of the University Hospital Basel (USB) and is one of the largest CR centers in Switzerland. Data regarding the Swiss population during and after CR is missing so far, thus creating a Swiss Prevention and Rehabilitation Registry (= SwissPR) on the basis of the KARAMBA infrastructure has the potential to collect missing data and address these questions. The results of the study will identify patient profiles at increased risk (special need patients) and will shed light into the mechanisms of poor secondary prevention behavior. The objective of SwissPR is to continuously monitor patient characteristics and short- and long-term benchmark quality measures and outcomes of patients participating in a 12-week ambulatory CR program.

For the prospective and retrospective part no recruitment or screening procedure is required. The procedure of enrolling patients for the prospective cohort of SwissPR patients is based on the participation in the CR program of the University Hospital Basel. Patients are routinely referred by various institutions for participation in the CR program according to predefined cardiovascular diagnosis. The retrospective part applies to data of patients, which have completed the CR program in Basel between 2017 and 2019.

Procedures:

Visit 1: Baseline, start of ambulatory CR program (approx. 60min): Patient characteristics including medical history, current medication, cardiovascular risk factors, routine laboratory analysis (including lipids, Hb1c, NT-proBNP), clinical status, electrocardiogram, echocardiography data from latest echo, cardio pulmonary exercise testing (CPET), questions on general health behavior (diet, weekly exercise load), Quality of Life and questions on socio-economic parameters.

Visit 2: End of CR program, 3 months after baseline (approx. 60 min.): Same measurements and procedures as at visit 1.

Visit 3: 1-year follow-up (approx. 15 min.): Same measurements and procedures as at visit 1 and 2 except for CPET.

Telephone follow-up and questionnaire 3 years after CR (approx. 15 min.): After checking vital status, the following end-points and information will be collected by telephone interview: hospitalisations since last follow-up (cardiac, non-cardiac), Major Cardiovascular Adverse Events (MACE) including cardiovascular mortality, myocardial infarction, stroke, revascularization, hospitalization for heart failure, smoking status and physical activity. The questionnaire contains questions on health behaviour, quality of life, depression and medication.

Telephone follow-up and questionnaire 5 years after CR (approx. 15 min.): Same interview and questionnaire as at 3-year follow-up.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

4000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Swiss Secondary Prevention and Rehabilitation Registry: SwissPR

Actual Study Start Date :

Dec 20, 2019

Anticipated Primary Completion Date :

Dec 1, 2035

Anticipated Study Completion Date :

Dec 1, 2035

Outcome Measures

Primary Outcome Measures

Change in Guideline recommended medical therapy [1 year]
Change in Guideline recommended medical therapy (Guideline recommended medical therapy is one variable in predefined secondary prevention benchmark performance measures (BPM) at one year after CR)
Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: LDL-Cholesterol target value [1 year]
Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: LDL-Cholesterol target value
Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: blood-pressure (systolic and diastolic) [1 year]
Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: Achievement of target blood-pressure
Change in smoking status [1 year]
Change in smoking status (smoking status is a predefined secondary prevention benchmark performance measures (BPM) at one year after CR: Achievement of Non-smoking status)
Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: exercise/ week [1 year]
Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: Achievement of 150 minutes of exercise/ week (self-reported)

Secondary Outcome Measures

Percentage of patients reaching the predefined secondary prevention benchmark after CR [3 months after baseline]
Percentage of patients reaching the predefined secondary prevention benchmark after CR
Change in physical activity [up to 5 years]
Change in physical activity (measured by exercise capacity (Watt) since last follow-up
Change in medical therapy between visits [up to 5 years]
Change in medical therapy between visits
Change in quality of life questionnaire/ score between visits [up to 5 years]
Change in quality of life questionnaire between visits. The questionnaire covers various attributes of an individuals life, summing the items for each life area for a total score (possible score range 0-96).
Change in Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention (TRS 2P) between visits [up to 5 years]
Change in Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention (TRS 2P): 3 categories: G1 (Low-risk; TRS-2P = 0/1); G2 (Intermediate-risk; TRS-2P = 2); and, G3 (High-risk; TRS-2P ≥ 3)
Change in total mortality after 1, 3 and 5 years [up to 5 years]
Number of total mortality after 1, 3 and 5 years
Change in total MACE after 1, 3 and 5 years [up to 5 years]
Change in total MACE after 1, 3 and 5 years