HypertensionSHIP-CARENCT06580613
Sustainable Hypertension Management in Primary Health Care in Sweden
A study testing New model of Hypertension Management in people with Hypertension, run by Region Skane at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension
- What is being tested?
- New model of Hypertension Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2025to Dec 2035
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult patients with hypertension
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Husensjö Primary Health Care Center
Helsingborg
Miriam Pikkemaat, PhD
About this study
Official title: Sustainable Hypertension Management in Primary Health Care in Sweden - Ett hållbart omhändertagande av Blodtryckspatienter i primärvården
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).
Read more
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
- Being tested
- New model of Hypertension Management, Control
- Keywords
- Primary Health Care, Management
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New model of Hypertension ManagementOther
Hypertension management based on cardiovascular risk assessment. For details see description of study arm intervention.
ControlOther
Hypertension Management as usual
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | At the Control Primary Health Care Centers care continues as usual Receives: Other: Control |
| Intervention | Experimental | 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 Receives: Other: New model of Hypertension Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure change
change in proportion of patients reaching blood pressure target of <140/90 mmHg
Measured: 6 months
Blood pressure change
change in proportion of patients reaching blood pressure target of <140/90 mmHg
Measured: 24 months
Secondary outcomes (7)
Health economic evaluation
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
Measured: 24 months
Participants grade of satisfaction
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
Measured: 24 months
Staffs grade of satisfaction
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
Measured: 24 months
Blood glucose level and cholesterol
Change in mean blood glucose level (mmol/l), mean LDL-cholesterol (mmol/l), mean HDL-cholesterol (mmol/l)
Measured: 24 months
Kidney function
Change in mean eGFR (ml/min/1,73 m2)
Measured: 24 months
Kidney complications
Change in % of patients with microalbuminuria (U-albumin/kreatinin-kvot (mg/mmol) 3,0-30)
Measured: 24 months
Smoking
Change in % of patients who smoke)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start1 Jan 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580613
- Sponsor's protocol ID
- 2024-03625-01
- Acronym
- SHIP-CARE
- Status last verified
- Sep 2026
- First submitted
- 21 Aug 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No