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Sustainable Hypertension Management in Primary Health Care in Sweden

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06580613
Acronym
SHIP-CARE
Enrollment
500
Registered
2024-08-30
Start date
2025-01-01
Completion date
2035-12-31
Last updated
2025-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Primary Health Care, Management

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.

Interventions

OTHERNew model of Hypertension Management

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

OTHERControl

Hypertension Management as usual

Sponsors

Region Skane
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Blood pressure change6 monthschange in proportion of patients reaching blood pressure target of \<140/90 mmHg

Secondary

MeasureTime frameDescription
Participants grade of satisfaction24 monthsQuestionnaires. 7 point Likert Scale: Level of Satisfaction - 7 point 1. \- Completely dissatisfied 2. \- Mostly dissatisfied 3. \- Somewhat dissatisfied 4. \- neither satisfied or dissatisfied 5. \- Somewhat satisfied 6. \- Mostly satisfied 7. \- Completely satisfied
Staffs grade of satisfaction24 monthsQuestionnaires. 7 point Likert Scale: Level of Satisfaction - 7 point 1. \- Completely dissatisfied 2. \- Mostly dissatisfied 3. \- Somewhat dissatisfied 4. \- neither satisfied or dissatisfied 5. \- Somewhat satisfied 6. \- Mostly satisfied 7. \- Completely satisfied
Blood glucose level and cholesterol24 monthsChange in mean blood glucose level (mmol/l), mean LDL-cholesterol (mmol/l), mean HDL-cholesterol (mmol/l)
Health economic evaluation24 monthsEstimation 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
Kidney complications24 monthsChange in % of patients with microalbuminuria (U-albumin/kreatinin-kvot (mg/mmol) 3,0-30)
Smoking24 monthsChange in % of patients who smoke)
Kidney function24 monthsChange in mean eGFR (ml/min/1,73 m2)

Countries

Sweden

Contacts

Primary ContactMiriam Pikkemaat, PhD
miriam.pikkemaat@med.lu.se0738185293

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026