Stable Chronic ConditionEQUIPAGENCT07784153
Evaluation of the Impact of Advanced Practice Nurses on Quality of Life in Primary Care in France
A study testing Care Pathways in people with Stable Chronic Condition, run by Le Mans Universite.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Stable Chronic Condition
- What is being tested?
- Care Pathways
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 880 participants
- Where
- No sites listed yet
- Study dates
- Jul 2028to Jul 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Violaine DUMUR contact
About this study
Official title: 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.
Read the 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.
- Conditions
- Stable Chronic Condition
- Being tested
- Care Pathways
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care PathwaysOther
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.
| Study group | Role | What they receive |
|---|---|---|
| CG + APN | Experimental | Not described Receives: Other: Care Pathways |
| GP alone | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study startJul 2028 (estimated)
- Primary completionJul 2030 (estimated)
- Study completionJul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable Chronic ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 880 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Le Mans Universite
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784153
- Sponsor's protocol ID
- GAINS - 2026 - 001
- Acronym
- EQUIPAGE
- Status last verified
- Aug 2026
- First submitted
- 2 Jul 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07784153
- Acronym / sponsor ID
- EQUIPAGE / GAINS - 2026 - 001
- Conditions
- Stable Chronic Condition
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 880 participants (estimated)
- Lead sponsor
- Le Mans UniversiteUniversity, hospital or other
- Study start
- Jul 2028 (estimated)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2032 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CG + APN | Experimental | Other: Care Pathways |
| GP alone | No intervention | – |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care PathwaysA 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. | Other | CG + APN |
Primary outcome
Change in physical quality of life
Time frame: 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).
1 secondary outcome
Effectiveness of an MG+AP care pathway 1
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Violaine DUMUR contact
Questions about this trial
What is this clinical trial studying?
A study testing Care Pathways in people with Stable Chronic Condition, run by Le Mans Universite.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aurelie TROTIN (+33687524814, Aurelie.Trotin@univ-lemans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical quality of life (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.