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

NCT05780762 | Recruiting

• 2 other identifiers: 21GI262ANSM
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 5

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.

Conditions

Chronic Disease

Keywords

advanced practice nurse (APN); patient partnership; health literacy; self-management

Outcome Measures

Primary Outcomes (1)

• The patient/advanced practice nurse partnership

  The patient/advanced practice nurse partnership will be assessed by a measure via the PIH-Fv (Partners In Health scale French version) questionnaire at 9 months. The PIH-Fv (Partners In Health scale in French version) questionnaire was developed and validated in French by Hudon et al. The PIH-Fv scale is a self-assessment questionnaire that includes 12 items, which are answered using 9-point Likert-type scales. The total score goes from 0 to 96: 0 representing poor self-management and 96 better self-management.

  At month 9

Secondary Outcomes (9)

• The patient/advanced practice nurse partnership across the continuum of care

  baseline, 3 and 6 months

• Perception of health-related quality of life

  At inclusion, 3, 6 and 9 months.

• Health literacy level

  at inclusion, 3, 6 and 9 months

• Impact of the quality of advanced practice nurse consultation from patient's perspective

  At baseline, 3, 6 and 9 months

• Adoption of IMPACT program by advanced practice nurse

  3 years

Study Arms (2)

IMPACT program - experimental group

EXPERIMENTAL

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.

Other: IMPACT Program

Usal care : control group

SHAM COMPARATOR

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

Other: usal care

Interventions

IMPACT Program 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.

IMPACT program - experimental group

usal care OTHER

usual management with a Nurse in Advanced Practice.

Usal care : control group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Ministry of Health, France: collaborator

Study Sites (5)

CH le Corbusier - Firminy

Firminy, 42700, France

NOT YET RECRUITING

Hôpital du Gier

Saint-Chamond, 42400, France

NOT YET RECRUITING

Centre Hospitalier Universitaire - Pneumologie

Saint-Etienne, 42055, France

NOT YET RECRUITING

Centre Hospitalier Universitaire - Cardiologie

Saint-Etienne, 42270, France

NOT YET RECRUITING

Direction de la Prévention et de la Santé des Populations

Saint-Etienne, France

RECRUITING

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elise VEROT, MD

  CHUSE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elise VEROT, MD

CONTACT

(0)682309796; elise.verot@univ-st-etienne.fr

Amandine BAUDOT, CRA

CONTACT

(0)477829450; Amandine.Baudot@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: March 23, 2023
• Study Start: April 12, 2024
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)