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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Aurelie TROTIN
- Telefonnummer: +33687524814
- E-post: Aurelie.Trotin@univ-lemans.fr
Studera Kontakt Backup
- Namn: Violaine DUMUR
- E-post: affaires-juridiques@univ-lemans.fr
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
|
Inget ingripande: GP alone
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in physical quality of life
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Effectiveness of an MG+AP care pathway 1
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Effectiveness of an MG+APN care pathway 2
Tidsram: 24 months
|
All-cause mortality reported in number of participant deaths, or similar
|
24 months
|
|
Therapeutic adherence
Tidsram: 12 and 24 months
|
Assessed using the GIRERD questionnaire (Girerd and al., 2001)
|
12 and 24 months
|
|
Evolution of the quality of life
Tidsram: 24 months
|
Assessed using the SF-36 questionnaire
|
24 months
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- GAINS - 2026 - 001
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