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Sustainable Hypertension Management in Primary Health Care in Sweden (SHIP-CARE)

R

Region Skane

Status

Enrolling

Conditions

Hypertension

Treatments

Other: Control
Other: New model of Hypertension Management

Study type

Interventional

Funder types

Other

Identifiers

NCT06580613
2024-03625-01

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

500 participants in 2 patient groups

Control
Active Comparator group
Description:
At the Control Primary Health Care Centers care continues as usual
Treatment:
Other: Control
Intervention
Experimental group
Description:
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
Treatment:
Other: New model of Hypertension Management

Trial contacts and locations

1

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Central trial contact

Miriam Pikkemaat, PhD

Data sourced from clinicaltrials.gov

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