Uppsala Self-Screening of Cardiovascular Health: A Randomized Controlled Trial of Home-Based Multimodal Cardiovascular Screening Versus Usual Care in Middle-Aged and Older Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 45,000
- Locations
- 1
Study Overview
Brief Summary
U-SCREEN is a randomized controlled trial evaluating whether systematic home-based multimodal screening for cardiovascular risk conditions, offered to residents in Region Uppsala turning 50, 55, 60, 65, 70 or 75 years of age, can identify clinically actionable cardiovascular risk factors more effectively than usual care. Participants randomized to the screening arm receive a home blood pressure measurement device, a dried blood spot sampling kit (for ApoB, HbA1c and creatinine), and a digital questionnaire. The control arm receives usual care. Recruitment runs 2024-2027 with a target identification of 10,000 cardiovascular risk conditions.
Detailed Description
BACKGROUND Cardiovascular disease remains the leading cause of death and disability in Sweden and globally. Hypertension, dyslipidemia, diabetes, atrial fibrillation, and chronic kidney disease are largely asymptomatic but treatable conditions for which effective preventive interventions exist. Despite this, a substantial proportion of affected individuals are undiagnosed or untreated. Population-based screening at clinics is resource-intensive and reaches only a fraction of those at risk. Digital tools and home-based self-sampling now make it feasible to scale cardiovascular screening to whole populations at limited marginal cost.
OBJECTIVES To determine whether a home-based multimodal cardiovascular screening program identifies more cardiovascular risk conditions than usual care in middle-aged and older adults. To evaluate the impact of screening on initiation of evidence-based preventive treatment; on cardiovascular events; on healthcare utilization and costs; and on participant-reported outcomes including health-related quality of life.
DESIGN Pragmatic, register-based, two-arm parallel-group randomized controlled trial. Eligible residents in Region Uppsala turning 50, 55, 60, 65, 70 or 75 years during the recruitment period are invited and, after digital informed consent, randomized 1:1 to the screening arm or the control arm.
INTERVENTION (SCREENING ARM)
Participants receive a home package containing:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- Single (Outcomes Assessor)
Masking Description
Open-label intervention; outcome assessment is performed via blinded extraction from national health registers and electronic health records.
Eligibility Criteria
- Ages
- 50 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Resident in Region Uppsala, Sweden
- •Turning 50, 55, 60, 65, 70 or 75 years during recruitment period
- •Able to provide informed consent
Exclusion Criteria
- •Inability to provide informed consent
- •Protected identity
Arms & Interventions
Screening
Home cardiovascular screening package: 7-day home BP measurement; dried blood spot self-sampling for ApoB, HbA1c and creatinine; digital questionnaire on lifestyle, symptoms, family history, diagnoses, medications. Above-threshold findings trigger initiation of guideline-recommended pharmacotherapy and referral to clinical care.
Intervention: Home-based multimodal cardiovascular screening (Behavioral)
Control
Usual care. No active screening offered as part of trial. Outcomes via national register and EHR linkage.
Investigators
Johan Sundström
Professor of Epidemiology, Consultant in Cardiology
Uppsala University