Sustainable Hypertension Management in Primary Health Care in Sweden (SHIP-CARE)

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).

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: Other: Control; Other: New model of Hypertension Management

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Miriam Pikkemaat, PhD; Phone Number: 0738185293; Email: miriam.pikkemaat@med.lu.se

Study Locations

• Sweden
  • Helsingborg, Sweden
    • Recruiting
    • Husensjö Primary Health Care Center
    • Contact: Miriam Pikkemaat, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; At the Control Primary Health Care Centers care continues as usual	Other: Control; Hypertension Management as usual
Experimental: Intervention; 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	Other: New model of Hypertension Management; Hypertension management based on cardiovascular risk assessment. For details see description of study arm intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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; - Completely dissatisfied; - Mostly dissatisfied; - Somewhat dissatisfied; - neither satisfied or dissatisfied; - Somewhat satisfied; - Mostly satisfied; - Completely satisfied	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	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

Collaborators and Investigators

• Sponsor: Region Skane

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2035

Study Registration Dates

• First Submitted: August 21, 2024
• First Submitted That Met QC Criteria: August 29, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Primary Health Care; Management
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: 2024-03625-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No