Sustainable Hypertension Management in Primary Health Care in Sweden
NCT Number: NCT06580613
Acronym: SHIP-CARE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypertension
Sponsor: Region Skane
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01
Completion Date: 2035-12

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.

Primary Outcome Measures: Blood pressure change, change in proportion of patients reaching blood pressure target of \<140/90 mmHg, 6 months|Blood pressure change, change in proportion of patients reaching blood pressure target of \<140/90 mmHg, 24 months
Secondary Outcome Measures: 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, 24 months|Participants grade of satisfaction, Questionnaires. 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, 24 months|Staffs grade of satisfaction, Questionnaires. 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, 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), 24 months|Kidney function, Change in mean eGFR (ml/min/1,73 m2), 24 months|Kidney complications, Change in % of patients with microalbuminuria (U-albumin/kreatinin-kvot (mg/mmol) 3,0-30), 24 months|Smoking, Change in % of patients who smoke), 24 months