Uppsala Self-Screening of Cardiovascular Health (U-SCREEN) (U-SCREEN)

May 20, 2026 updated by: Johan Sundström

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

45000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
      • Uppsala, Sweden, 751 85
        • Recruiting
        • Uppsala University Hospital
        • Contact:
        • Principal Investigator:
          • Sundström
        • Principal Investigator:
          • Wanhainen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
No Intervention: Control
Usual care. No active screening offered as part of trial. Outcomes via national register and EHR linkage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of total major adverse cardiovascular events over 10 years
Time Frame: Within 10 years after randomization
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
Within 12 months after randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality
Time Frame: Within 10 years after randomization.
Within 10 years after randomization.
Rate of cardiovascular deaths
Time Frame: Within 10 years after randomization.
Within 10 years after randomization.
Rate of total hospitalizations and deaths
Time Frame: Within 10 years after randomization.
Within 10 years after randomization.
Rate of cardiovascular hospitalizations and deaths from ischaemic heart disease
Time Frame: Within 10 years after randomization.
Within 10 years after randomization.
Rate of cardiovascular hospitalizations and deaths from cerebrovascular heart disease
Time Frame: Within 10 years after randomization.
Within 10 years after randomization.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johan Sundström

Collaborators

Region of Uppsala

Investigators

  • Principal Investigator: Johan Sundström, MD, PhD, Uppsala University
  • Principal Investigator: Anders Wanhainen, MD, PhD, Uppsala University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2037

Study Registration Dates

First Submitted

May 20, 2026

First Submitted That Met QC Criteria

May 20, 2026

First Posted (Actual)

May 29, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U-SCREEN
  • 2024-03135-01 (Other Identifier: Swedish Ethical Review Authority)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Decisions on sharing of de-identified IPD will follow Swedish and EU data protection legislation and sponsor/Uppsala University policies. Aggregate results will be published in peer-reviewed journals.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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