I10 E10-E14 E78 N18
Conditions
Interventions
Group 1: As part of the study, screening assessments for HbA1c, urinary albumin-to-creatinine ratio (UACR), blood pressure, and lipid profile are conducted in on-site pharmacies. Initial assessments a
Sponsors
UKSH Campus Kiel, Klinik für Innere Medizin IV mit den Schwerpunkten Nieren- und Hochdruckkrankheiten
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants must meet all of the following criteria: • Established regular care by a general practitioner • Presence of at least one cardiovascular–metabolic risk indicator, defined as one or more of the following: • Active smoking, or • Prescription of risk-related medication, including antihypertensive, antidiabetic, or lipid-lowering medication, or • Obesity, defined as a body mass index (BMI) = 30 kg/m² or increased waist circumference (= 88 cm for women or = 102 cm for men)
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will be excluded: • Participation in another clinical study • Inability to provide written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (I) Participant-level feasibility The primary feasibility outcome is the participant-level screening completion rate. The outcome is defined as complete completion of the structured patient history, blood pressure measurement, and point-of-care testing for dyslipidemia and HbA1c. Assessment is performed after full enrollment of n = 1,000 participants. The predefined target criterion is an overall completion rate of = 70%. (II) Implementation outcomes from the pharmacy perspective Implementation quality is evaluated across the domains of acceptability, feasibility, and sustainability. Assessment is conducted after full enrollment of n = 1,000 participants using validated, standardized self-administered questionnaires completed by pharmacy staff, including the Acceptability of Intervention Measure (AIM), the Feasibility of Intervention Measure (FIM), and the Normalization Measure Development Questionnaire (NoMad). Ratings are based on Likert scales using validated German versions of the instruments. The outcome is defined as a median Likert-scale score = 3 across all three domains. (III) Screening yield Screening yield is quantified by the number needed to screen (NNS) to identify at least one previously unknown or insufficiently treated cardiovascular–kidney–metabolic (CKM) syndrome risk factor. Assessment is based on screening results and, where applicable, confirmatory testing outcomes. The predefined target criterion is an NNS = 5. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include: • Rate of general practitioner consultations; assessed after completion of follow-up using a structured questionnaire. • Therapy-related consequences (initiation or modification of medication); assessed after completion of follow-up using a structured questionnaire. • Diagnostic performance metrics of the screening (sensitivity, specificity, positive predictive value, and negative predictive value); assessed after completion of recruitment and confirmatory testing. • Workload- and process-related metrics; assessed after completion of recruitment and screening procedures. | — |
Countries
Germany
Contacts
Public ContactFriedrich von Samson-Himmelstjerna
UKSH Campus Kiel, Klinik für Innere Medizin IV mit den Schwerpunkten Nieren- und Hochdruckkrankheiten
Outcome results
None listed