Sustainable Hypertension Management in Primary Health Care in Sweden

NCT ID: NCT06580613

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2035-12-31

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

At the Control Primary Health Care Centers care continues as usual

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

Hypertension Management as usual

Intervention

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

Group Type: EXPERIMENTAL

New model of Hypertension Management

Intervention Type: OTHER

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

Interventions

New model of Hypertension Management

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

Intervention Type: OTHER

Control

Hypertension Management as usual

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult patients with hypertension

Exclusion Criteria

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Husensjö Primary Health Care Center

Helsingborg, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Miriam Pikkemaat, PhD

Role: CONTACT

miriam.pikkemaat@med.lu.se

0738185293

Facility Contacts

Miriam Pikkemaat, PhD

Role: primary

Other Identifiers

2024-03625-01

Identifier Type: -

Identifier Source: org_study_id