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

Access to primary care in France is increasingly constrained due to demographic changes, regional disparities in physician distribution, and the rising prevalence of chronic diseases. APNs were introduced to improve access to care and the coordination of patient management. While the international literature suggests their effectiveness, robust data in the French context remain limited. The objective of this study is to evaluate the impact of a coordinated general practitioner (GP)+APN care pathway on patients' quality of life.

Study Overview

• Status: Not yet recruiting
• Conditions: Stable Chronic Condition
• Intervention / Treatment: Other: Care Pathways

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 880
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aurelie TROTIN; Phone Number: +33687524814; Email: Aurelie.Trotin@univ-lemans.fr
• Study Contact Backup: Name: Violaine DUMUR; Email: affaires-juridiques@univ-lemans.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CG + APN	Other: Care Pathways; 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.
No Intervention: GP alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in physical quality of life	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of an MG+AP care pathway 1	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of an MG+APN care pathway 2	All-cause mortality reported in number of participant deaths, or similar	24 months
Therapeutic adherence	Assessed using the GIRERD questionnaire (Girerd and al., 2001)	12 and 24 months
Evolution of the quality of life	Assessed using the SF-36 questionnaire	24 months

Collaborators and Investigators

• Sponsor: Le Mans Universite

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2028
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2032

Study Registration Dates

• First Submitted: July 2, 2026
• First Submitted That Met QC Criteria: August 21, 2026
• First Posted (Actual): August 25, 2026

Study Record Updates

• Last Update Posted (Actual): August 25, 2026
• Last Update Submitted That Met QC Criteria: August 21, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Services Administration; Patient Care Management; Patient Care Planning; Comprehensive Health Care; Critical Pathways
• Other Study ID Numbers: GAINS - 2026 - 001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No