Bærekraftig hypertensjonsbehandling i primærhelsetjenesten i Sverige (SHIP-CARE)
Bærekraftig hypertensjonsbehandling i primærhelsetjenesten 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Miriam Pikkemaat, PhD
- Telefonnummer: 0738185293
- E-post: miriam.pikkemaat@med.lu.se
Studiesteder
-
-
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Helsingborg, Sverige
- Rekruttering
- Husensjö Primary Health Care Center
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Ta kontakt med:
- Miriam Pikkemaat, PhD
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Control
At the Control Primary Health Care Centers care continues as usual |
Hypertension Management as usual |
|
Eksperimentell: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2024-03625-01
Plan for individuelle deltakerdata (IPD)
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