Sustainable Hypertension Management in Primary Health Care in Sweden

ConditionHypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorRegion Skane

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

secondary hypertension according to the medical records at the Primary Health Care Center

terminal illness

pregnancy-induced hypertension

cognitive impairment

Trial design

Design model

Parallel

Treatments tested in this trial

  • New model of Hypertension Management

    Other intervention

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

  • Control

    Other intervention

    Hypertension Management as usual

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Blood pressure change

change in proportion of patients reaching blood pressure target of \<140/90 mmHg

Time frame
6 months
2

Blood pressure change

change in proportion of patients reaching blood pressure target of \<140/90 mmHg

Time frame
24 months

Secondary outcomes

1

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

Time frame
24 months
2

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

Time frame
24 months
3

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

Time frame
24 months
4

Blood glucose level and cholesterol

Change in mean blood glucose level (mmol/l), mean LDL-cholesterol (mmol/l), mean HDL-cholesterol (mmol/l)

Time frame
24 months

Other outcomes

Sponsors and contacts

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