Impact of an Intervention Integrating the MPHS Nursing Model of Care on the Partnership in Health, With the Patient Followed in Primary Care by an Advanced Practice Nurse (APN) for One or More Stabilized Chronic Pathologies

NCT ID: NCT05780762

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-12
• Study Completion Date: 2028-11-30

Brief Summary

The WHO and our governance advocate that health professionals should organize care around the patient, considering his or her values, needs and preferences, and enabling the patient to develop the capacity to self-manage the chronic health problems he or she faces. Chronic disease is an ongoing dynamic process and adaptation to this process is complicated by the interaction of several determinants: self-management capacity, level of health literacy, quality of life and experience of care. To best support chronic disease, the recommendation is to adopt a management strategy that allows chronic patients to play an active role in the management of their condition and in the day-to-day decision-making process. The management of chronic pathologies is one of the specialties in which Advanced Practice Nurses are positioned, in primary care, outside hospital. Nursing care benefits from care models that allow for more adapted responses, regarding particular care situations, or certain patient typologies. The Humanistic Partnership Health Care Model (MPHS) implement in current Advanced Practice Nurse (APN) practice.

Detailed Description

The IMPACT program proposes to integrate the MPHS model into primary care, within advanced practice nursing care, to strengthen the partnership of the patient with chronic disease. This model will allow the advanced practice nurse to co-construct with the patient partner a care trajectory that will be integrative, considering his aspirations and priorities to carry out his life project, while coping with his chronic pathology(ies). To do this, particular attention to the determinants of adaptation to chronic disease: self-management capacity, health literacy, quality of life and experience of care is pay.

The IMPACT program will use the theoretical framework of the MPHS model of care to structure the advanced practice nursing care management and will incorporate validated measurement tools to address the determinants of patient adaptation to chronic disease. The specific management of the IMPACT program will consist of 3 phases: (1) co-definition of the health situation, (2) co-planning of care and co-actions, and (3) co-assessment with the patient and the team caring for him/her.

Conditions

Chronic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

IMPACT program - experimental group

patients followed for one or more stabilized chronic pathologies and benefiting from usual care with an Advanced Practice Nurse AND benefiting from the IMPACT program, which combines management at 3 levels: (1) co-definition of the health situation, (2) co-planning of care and co-actions, and (3) co-assessment with the patient and his or her care team, and incorporates evidence-based measurement tools.

Group Type: EXPERIMENTAL

IMPACT Program

Intervention Type: OTHER

care at 3 levels:

(1) co-definition of the health situation, (2) co-planning of care and co-actions, and (3) co-assessment with the patient and with the team caring for him or her, and incorporating evidence-based measurement tools.

Usal care : control group

patients followed for one or several stabilized chronic pathology(ies) and benefiting from a usual management with a Nurse in Advanced Practice.

Group Type: SHAM_COMPARATOR

usal care

Intervention Type: OTHER

usual management with a Nurse in Advanced Practice.

Interventions

IMPACT Program

care at 3 levels:

(1) co-definition of the health situation, (2) co-planning of care and co-actions, and (3) co-assessment with the patient and with the team caring for him or her, and incorporating evidence-based measurement tools.

Intervention Type: OTHER

usal care

usual management with a Nurse in Advanced Practice.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Followed by APN, within the framework of an organizational protocol established with a patient's referring physician, for the management of one or more chronic pathology(ies) from the following list: stroke; chronic arterial disease; heart disease, coronary artery disease; type 1 diabetes and type 2 diabetes; chronic respiratory failure; Parkinson's disease; epilepsy
• Affiliated or entitled to a social security plan
• Having received informed information about the study and having co-signed, with the investigator, a consent to participate in the study

Exclusion Criteria

• Patient not referred by a physician for APN follow-up

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elise VEROT, MD

Role: PRINCIPAL_INVESTIGATOR

CHUSE

Locations

CH le Corbusier - Firminy

Firminy, , France

Site Status: NOT_YET_RECRUITING

Hôpital du Gier

Saint-Chamond, , France

Site Status: NOT_YET_RECRUITING

Centre Hospitalier Universitaire - Pneumologie

Saint-Etienne, , France

Site Status: NOT_YET_RECRUITING

Centre Hospitalier Universitaire - Cardiologie

Saint-Etienne, , France

Site Status: NOT_YET_RECRUITING

Direction de la Prévention et de la Santé des Populations

Saint-Etienne, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Elise VEROT, MD

Role: CONTACT

elise.verot@univ-st-etienne.fr

(0)682309796 ext. +33

Amandine BAUDOT, CRA

Role: CONTACT

Amandine.Baudot@chu-st-etienne.fr

(0)477829450 ext. +33

Facility Contacts

Yanis MASSARD

Role: primary

ymassard.ide@laposte.net

(0)662717532 ext. +33

Pierrine FORISSIER

Role: primary

pierrine.forissier@laposte.net

(0)675443635 ext. +33

Fabien CHOLVY

Role: primary

fabien.cholvy@chu-st-etienne.fr

(0)477829767 ext. +33

Delphine HANOTTE

Role: primary

delphine.hanotte@chu-st-etienne.fr

(0)477829805 ext. +33

Other Identifiers

ANSM

Identifier Type: OTHER

Identifier Source: secondary_id

21GI262

Identifier Type: -

Identifier Source: org_study_id