Clinical trial NCT06580613: Sustainable Hypertension Management in Primary Health Care in Sweden
Official title: Sustainable Hypertension Management in Primary Health Care in Sweden - Ett hållbart omhändertagande av Blodtryckspatienter i primärvården
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: Primary Health Care
Management
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Blood pressure change
timeFrame: 6 months
measure: Blood pressure change
timeFrame: 24 months
Secondary outcomes:
measure: Health economic evaluation
timeFrame: 24 months
measure: Participants grade of satisfaction
timeFrame: 24 months
measure: Staffs grade of satisfaction
timeFrame: 24 months
measure: Blood glucose level and cholesterol
timeFrame: 24 months
measure: Kidney function
timeFrame: 24 months
measure: Kidney complications
timeFrame: 24 months
measure: Smoking
timeFrame: 24 months
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Husensjö Primary Health Care Center
Study officials:
References: