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NCT Number: NCT06580613

Sustainable Hypertension Management in Primary Health Care in Sweden

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Husensjö Primary Health Care Center

Helsingborg, Sweden

Location status: Recruiting

Location contact

Miriam Pikkemaat, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

New model of Hypertension Management

Other

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

Control

Other

Hypertension Management as usual

Primary outcomes

  1. Blood pressure change

    Time frame: 6 months

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

  2. Blood pressure change

    Time frame: 24 months

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

Secondary outcomes

  1. Health economic evaluation

    Time frame: 24 months

    Estimation of the ICER values (cost per unit of effect). Calculation of QALY, based on EQ5D (questionnaires). Comparison of ICER per QALY with values from the National Board of Health and Welfare

  2. Participants grade of satisfaction

    Time frame: 24 months

    Questionnaires. 7 point Likert Scale: Level of Satisfaction - 7 point

    • - Completely dissatisfied
    • - Mostly dissatisfied
    • - Somewhat dissatisfied
    • - neither satisfied or dissatisfied
    • - Somewhat satisfied
    • - Mostly satisfied
    • - Completely satisfied

  3. Staffs grade of satisfaction

    Time frame: 24 months

    Questionnaires. 7 point Likert Scale: Level of Satisfaction - 7 point

    • - Completely dissatisfied
    • - Mostly dissatisfied
    • - Somewhat dissatisfied
    • - neither satisfied or dissatisfied
    • - Somewhat satisfied
    • - Mostly satisfied
    • - Completely satisfied

  4. Blood glucose level and cholesterol

    Time frame: 24 months

    Change in mean blood glucose level (mmol/l), mean LDL-cholesterol (mmol/l), mean HDL-cholesterol (mmol/l)

  5. Kidney function

    Time frame: 24 months

    Change in mean eGFR (ml/min/1,73 m2)

  6. Kidney complications

    Time frame: 24 months

    Change in % of patients with microalbuminuria (U-albumin/kreatinin-kvot (mg/mmol) 3,0-30)

  7. Smoking

    Time frame: 24 months

    Change in % of patients who smoke)

Study contacts

Contact information is provided by the study sponsor or research team.

Miriam Pikkemaat, PhD

CONTACT

[email protected]

0738185293

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

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

Acronym: SHIP-CARE

Important dates

Study start
2025
Primary completion
2028
Study completion
2035
First posted
Aug 30, 2024
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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