NCT06580613

Brief Summary

New sustainable models of patient-focused and team-based care for patients with hypertension should be developed to achieve health improvements and cost-efficiency. The aim of this project is to evaluate new ways of sustainable hypertension (HT) management in primary care, starting with a pilot study at 2 Primary Health Care Centres (PHCCs). At intervention PHCCs cardiovascular risk is assessed with SCORE2 for all hypertension patients. The staff receives education on HT treatment and an easy-to-follow treatment protocol. Non-physicians lead patient education on HT in groups. Patients receive a home blood pressure (BP) monitor and communicate digitally with the assigned nurse on medication update, blood and urinary tests and follow up. The nurse consults with the physician if needed. Regular face to face visits with the physician are only scheduled for patients with high cardiovascular risk or end organ damage, otherwise for all patients if needed. At the control PHCs hypertension care continues as usual. All participants will be asked to complete questionnaires after 6 and 24 months. Outcomes are feasibility for the pilot study and the proportion of patients reaching BP target plus change in systolic BP, cardiovascular risk factors, patients´ and staff´s grade of satisfaction and knowledge, and health care costs for the main study, compared between intervention and control PHCCS. Results will help to establish sustainable models of treating HT patients in Primary Care.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
116mo left

Started Jan 2025

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Jan 2025Dec 2035

First Submitted

Initial submission to the registry

August 21, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 30, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2035

Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

3.9 years

First QC Date

August 21, 2024

Last Update Submit

April 1, 2025

Conditions

Hypertension

Keywords

Primary Health CareManagement

Outcome Measures

Primary Outcomes (2)

  • Blood pressure change

    change in proportion of patients reaching blood pressure target of \<140/90 mmHg

    6 months

  • Blood pressure change

    change in proportion of patients reaching blood pressure target of \<140/90 mmHg

    24 months

Secondary Outcomes (7)

  • Health economic evaluation

    24 months

  • Participants grade of satisfaction

    24 months

  • Staffs grade of satisfaction

    24 months

  • Blood glucose level and cholesterol

    24 months

  • Kidney function

    24 months

  • +2 more secondary outcomes

Study Arms (2)

Control

ACTIVE COMPARATOR

At the Control Primary Health Care Centers care continues as usual

Other: Control

Intervention

EXPERIMENTAL

Hypertension management based on cardiovascular risk assessment. Low/medium risk: Digital contact with nurse, contact with GP only if needed High risk: Planned contacts with GP Group education on Hypertension for staff and participants

Other: New model of Hypertension Management

Interventions

New model of Hypertension ManagementOTHER

Hypertension management based on cardiovascular risk assessment. For details see description of study arm intervention.

Intervention
ControlOTHER

Hypertension Management as usual

Control

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- Adult patients with hypertension

You may not qualify if:

  • secondary hypertension according to the medical records at the Primary Health Care Center
  • terminal illness
  • pregnancy-induced hypertension
  • cognitive impairment
  • impaired vision (not able to read measurements for the home BP measurements or communicate via "1177 direct" digitally)
  • psychotic disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Husensjö Primary Health Care Center

Helsingborg, Sweden

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Miriam Pikkemaat, PhD

CONTACT

0738185293miriam.pikkemaat@med.lu.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2024

First Posted

August 30, 2024

Study Start

January 1, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2035

Last Updated

April 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)