Bæredygtig hypertensionsbehandling i primær sundhedspleje i Sverige (SHIP-CARE)
Bæredygtig hypertensionsbehandling i primær sundhedspleje i Sverige - 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Miriam Pikkemaat, PhD
- Telefonnummer: 0738185293
- E-mail: miriam.pikkemaat@med.lu.se
Studiesteder
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-
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Helsingborg, Sverige
- Rekruttering
- Husensjö Primary Health Care Center
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Kontakt:
- Miriam Pikkemaat, PhD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Control
At the Control Primary Health Care Centers care continues as usual |
Hypertension Management as usual |
|
Eksperimentel: 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 |
Hypertension management based on cardiovascular risk assessment. For details see description of study arm intervention. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Blood pressure change
Tidsramme: 6 months
|
change in proportion of patients reaching blood pressure target of <140/90 mmHg |
6 months
|
|
Blood pressure change
Tidsramme: 24 months
|
change in proportion of patients reaching blood pressure target of <140/90 mmHg |
24 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Health economic evaluation
Tidsramme: 24 months
|
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
Tidsramme: 24 months
|
Questionnaires. 7 point Likert Scale: Level of Satisfaction - 7 point
|
24 months
|
|
Staffs grade of satisfaction
Tidsramme: 24 months
|
Questionnaires. 7 point Likert Scale: Level of Satisfaction - 7 point
|
24 months
|
|
Blood glucose level and cholesterol
Tidsramme: 24 months
|
Change in mean blood glucose level (mmol/l), mean LDL-cholesterol (mmol/l), mean HDL-cholesterol (mmol/l) |
24 months
|
|
Kidney function
Tidsramme: 24 months
|
Change in mean eGFR (ml/min/1,73 m2) |
24 months
|
|
Kidney complications
Tidsramme: 24 months
|
Change in % of patients with microalbuminuria (U-albumin/kreatinin-kvot (mg/mmol) 3,0-30) |
24 months
|
|
Smoking
Tidsramme: 24 months
|
Change in % of patients who smoke) |
24 months
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2024-03625-01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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