Evaluation of the Impact of Advanced Practice Nurses on Quality of Life in Primary Care in France (EQUIPAGE)
EQUIPAGE Trial: Protocol for a Pragmatic, Multicenter, Randomized Controlled Trial Evaluating the Impact of Advanced Practice Nurses (APNs) on Quality of Life in Primary Care in France
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
EQUIPAGE is a pragmatic, multicenter, open-label, randomized controlled superiority trial. A total of 880 adult patients with stable chronic conditions will be randomized (1:1) between standard care by GP alone and coordinated GP+APN care. The follow-up period is 24 months. The primary outcome measure is the change in physical quality of life at 12 months as measured by the SF-36. Secondary outcomes include hospitalizations, emergency department visits, mortality, adherence, and patient satisfaction. Analyses will be based on mixed-effects models accounting for repeated measures and the multicenter design.
This trial will provide the first randomized data on the impact of APNs in primary care in France and will help inform decisions regarding the organization of care.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Aurelie TROTIN
- Telefonnummer: +33687524814
- E-post: Aurelie.Trotin@univ-lemans.fr
Studer Kontakt Backup
- Navn: Violaine DUMUR
- E-post: affaires-juridiques@univ-lemans.fr
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- 18 years old or older patients,
- patients with a stable chronic condition falling under the indications defined by the french decree of July 18, 2018,
- patients under the care of a general practitioner (GP),
- patients who have signed an informed consent form.
Exclusion Criteria:
- patients with cognitive impairments that compromise their ability to participate in the study,
- patients who require exclusively medical care without the possibility of coordination,
- patients already receiving care in a setting that includes a primary care nurse;
- pregnant women;
- patients with no legal capacity.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: CG + APN
|
A process evaluation will be conducted to document the implementation of the " intervention . It will focus on care pathways, the distribution of consultations, APN activities, deviations from the protocol, and the organizational characteristics of the facilities. |
|
Ingen inngripen: GP alone
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in physical quality of life
Tidsramme: 12 months
|
The primary outcome is the change in physical quality of life at 12 months, measured by the physical composite score of the SF-36 questionnaire. This score aggregates four dimensions: physical activity, physical limitations, physical pain, and perceived health. The SF-36 is a validated tool for measuring health-related quality of life (Ware & Sherbourne, 1992). |
12 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Effectiveness of an MG+AP care pathway 1
Tidsramme: 24 months
|
Measured by the number of unplanned hospitalizations and the number of visits to hospitals and/or emergency departments, in relation to the condition(s) justifying inclusion.
|
24 months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Effectiveness of an MG+APN care pathway 2
Tidsramme: 24 months
|
All-cause mortality reported in number of participant deaths, or similar
|
24 months
|
|
Therapeutic adherence
Tidsramme: 12 and 24 months
|
Assessed using the GIRERD questionnaire (Girerd and al., 2001)
|
12 and 24 months
|
|
Evolution of the quality of life
Tidsramme: 24 months
|
Assessed using the SF-36 questionnaire
|
24 months
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GAINS - 2026 - 001
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .