Evaluation of the Impact of Advanced Practice Nurses on Quality of Life in Primary Care in France

NCT07784153 | Not Yet Recruiting

• 1 other identifier: GAINS - 2026 - 001
• Study Type: interventional
• Target: 880
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Stable Chronic Condition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Effectiveness of an MG+AP care pathway 1

  24 months

Other Outcomes (3)

• Effectiveness of an MG+APN care pathway 2

  24 months

• Therapeutic adherence

  12 and 24 months

• Evolution of the quality of life

  24 months

Study Arms (2)

CG + APN

EXPERIMENTAL

Other: Care Pathways

GP alone

NO INTERVENTION

Interventions

Care Pathways OTHER

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.

CG + APN

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Le Mans Universite: lead

MeSH Terms

Interventions

Critical Pathways

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Central Study Contacts

Aurelie TROTIN

CONTACT

+33687524814; Aurelie.Trotin@univ-lemans.fr

Violaine DUMUR

CONTACT

affaires-juridiques@univ-lemans.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: August 25, 2026
• Study Start (Estimated): July 1, 2028
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2032
• Last Updated: August 25, 2026

Record last verified: 2026-08