Swiss Secondary Prevention and Rehabilitation Registry
ConditionCardiovascular Diseases (CVD)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity Hospital, Basel, Switzerland
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participation in an ambulatory CR program (all age groups)
Written informed consent
Disqualifiers
Inability to follow an ambulatory CR program more than 3 weeks
Not willing to give informed consent
Inability to understand the informed consent due to language comprehension
Lack of discernment
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
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
Other interventionData collection (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)
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Change in Guideline recommended medical therapy
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)
Time frame
1 year2
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: LDL-Cholesterol target value
Time frame
1 year3
Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: blood-pressure (systolic and diastolic)
Change in predefined secondary prevention benchmark performance measures (BPM) at one year after CR: Achievement of target blood-pressure
Time frame
1 year4
Change in smoking status
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)
Time frame
1 yearSecondary outcomes
1
Percentage of patients reaching the predefined secondary prevention benchmark after CR
Percentage of patients reaching the predefined secondary prevention benchmark after CR
Time frame
3 months after baseline2
Change in physical activity
Change in physical activity (measured by exercise capacity (Watt) since last follow-up
Time frame
up to 5 years3
Change in medical therapy between visits
Change in medical therapy between visits
Time frame
up to 5 years4
Change in quality of life questionnaire/ score between visits
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).
Time frame
up to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov