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Recruiting NCT06580613

Sustainable Hypertension Management in Primary Health Care in Sweden

No phase Interventional Hypertension

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: New model of Hypertension Management, Control.
Who it may be relevant to
Registry conditions: Hypertension. Basic parameters: No limits · 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 →
Official title

Sustainable Hypertension Management in Primary Health Care in Sweden - Ett hållbart omhändertagande av Blodtryckspatienter i primärvården

Overview

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.

Interventions

  • Other New model of Hypertension Management
    Hypertension management based on cardiovascular risk assessment. For details see description of study arm intervention.
  • Other Control
    Hypertension Management as usual

Primary outcome measures

  • Blood pressure change [Time frame: 6 months]
  • Blood pressure change [Time frame: 24 months]
Secondary outcome measures (7)
  • Health economic evaluation [Time frame: 24 months]
  • Participants grade of satisfaction [Time frame: 24 months]
  • Staffs grade of satisfaction [Time frame: 24 months]
  • Blood glucose level and cholesterol [Time frame: 24 months]
  • Kidney function [Time frame: 24 months]
  • Kidney complications [Time frame: 24 months]
  • Smoking [Time frame: 24 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Sweden · 1 center
  • Husensjö Primary Health Care Center — Helsingborg

Identifiers

NCT: NCT06580613 · 2024-03625-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗