Uppsala Self-Screening of Cardiovascular Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Home-based multimodal cardiovascular screening.
- Who it may be relevant to
- Registry conditions: Cardiovascular Diseases, Hypertension, Dyslipidemias, Diabetes Mellitus. Basic parameters: 50 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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:
* A validated automated upper-arm blood pressure monitor with instructions for a 7-day home measurement schedule; * A dried blood spot sampling kit for self-collection and mail-back analysis of ApoB, HbA1c, and creatinine; * A digital questionnaire on lifestyle, symptoms, family history, and existing diagnoses and medications.
Results are returned to the participant via a digital portal together with structured advice; participants with findings exceeding pre-specified thresholds receive guideline-directed pharmacotherapy and are referred for clinical follow-up in routine care.
COMPARATOR (CONTROL ARM) Usual care, with no active screening offered as part of the trial.
OUTCOME ASCERTAINMENT Outcomes are ascertained primarily through linkage to Swedish national health registers (the National Patient Register, the Swedish Prescribed Drug Register, the Cause of Death Register, and quality registers including SWEDEHEART and the Swedish Primary Care Cardiovascular Database) and to regional electronic health records.
SAMPLE SIZE AND ANALYSIS The trial targets identification of 10,000 cardiovascular risk conditions. Analyses follow the intention-to-treat principle.
Interventions
- Behavioral Home-based multimodal cardiovascular screening
Self-administered home-based screening program: 7-day home BP, DBS biomarker self-sampling, digital questionnaire; structured digital return of results; threshold-based initiation of guideline-recommended pharmacotherapy and referral to clinical care.
Primary outcome measures
- Rate of total major adverse cardiovascular events over 10 years [Time frame: Within 10 years after randomization]
- Number of initiated guideline-recommended pharmacotherapies for cardiovascular risk factors within 12 months [Time frame: Within 12 months after randomization]
Secondary outcome measures (5)
- All-cause mortality [Time frame: Within 10 years after randomization.]
- Rate of cardiovascular deaths [Time frame: Within 10 years after randomization.]
- Rate of total hospitalizations and deaths [Time frame: Within 10 years after randomization.]
- Rate of cardiovascular hospitalizations and deaths from ischaemic heart disease [Time frame: Within 10 years after randomization.]
- Rate of cardiovascular hospitalizations and deaths from cerebrovascular heart disease [Time frame: Within 10 years after randomization.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Screening
Study locations
Sweden · 1 center
- Uppsala University Hospital — Uppsala
Identifiers
NCT: NCT07614659 · U-SCREEN · 2024-03135-01