Chronic DiseaseIMPACTNCT05780762
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
A study testing IMPACT Program and usal care in people with Chronic Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease
- What is being tested?
- IMPACT Program and usal care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 5 sitesFrance
- Study dates
- 12 Apr 2024to 30 Nov 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A patient receiving care from an advanced practice nurse (APN) for the management of one or more of the following chronic conditions: stroke; chronic arterial disease; heart disease, coronary artery disease; type 1 diabetes and type 2 diabetes; chronic respiratory failure; Parkinson's disease; epilepsy.
- Care provided by an IPA falls under one of the following categories:
- Either as direct care when the IPA practices within a healthcare facility, in accordance with current regulations, Or as care referred or prescribed by a physician when the IPA practices in private practice.
- 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
Who cannot join
- A patient who is not under the care of a nurse practitioner under the conditions set forth in the Public Health Code (lack of authorized direct access or a required physician referral, depending on the practice model).
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Not yet recruiting
CH le Corbusier - Firminy
Firminy, 42700
Yanis MASSARD, (0)662717532 ext. +33, ymassard.ide@laposte.net
- Not yet recruiting
Hôpital du Gier
Saint-Chamond, 42400
Pierrine FORISSIER, (0)675443635 ext. +33, pierrine.forissier@laposte.net
- Not yet recruiting
Centre Hospitalier Universitaire - Pneumologie
Saint-Etienne, 42055
Fabien CHOLVY, (0)477829767 ext. +33, fabien.cholvy@chu-st-etienne.fr
- Not yet recruiting
Centre Hospitalier Universitaire - Cardiologie
Saint-Etienne, 42270
Delphine HANOTTE, (0)477829805 ext. +33, delphine.hanotte@chu-st-etienne.fr
- Recruiting
Direction de la Prévention et de la Santé des Populations
Saint-Etienne
Elise VEROT, MD
About this study
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.
Read the 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
- Being tested
- IMPACT Program, usal care
- Keywords
- advanced practice nurse (APN), patient partnership, health literacy, self-management
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMPACT ProgramOther
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 careOther
usual management with a Nurse in Advanced Practice.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: usal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At month 9
Secondary outcomes (9)
The patient/advanced practice nurse partnership across the continuum of care
Measurement of the impact of the intervention on the partnership via the Partners In Health scale French version.This questionnaire 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.
Measured: baseline, 3 and 6 months
Perception of health-related quality of life
Measurement of the perception of health-related quality of life via the World Health Organisation Quality Of Life questionnaire. This questionnaire questions 4 domains: physical health, psychological health, social sphere and environment. The patient answers according to 3 groups of 5 modalities of the Likert scale. The first group goes from " very weak " to " very good"; the second goes from " very unsatisfied " to "very satisfied" ; the third goes from "not at all" to " extremely"
Measured: At inclusion, 3, 6 and 9 months.
Health literacy level
Measurement of health literacy level via the European Health Literacy Survey (HLS-EU16) questionnaire validated in French version. It consists of 16 items, for which the patient answers according 4 modalities "very easy" to "very difficult".
Measured: at inclusion, 3, 6 and 9 months
Impact of the quality of advanced practice nurse consultation from patient's perspective
Measurement of the impact of the advanced practice nurse consultation on the patient's perceived ability to understand and cope with his or her health problems and illness via the PEI questionnaire vf (Patient Enablement Instrument French version) questionnaire. It consists of 6 questions to which the patient responds in 3 ways "much more", "more", or "as before the visit or less"
Measured: At baseline, 3, 6 and 9 months
Adoption of IMPACT program by advanced practice nurse
Adoption of IMPACT program by advanced practice nurse will be assessed by number of advanced practice nurses including patients and number of patients followed by each APN
Measured: 3 years
Participation in IMPACT program
Participation in IMPACT program will be assessed by number of patients who agreed to be followed with this model of care/number of patients who were offered follow-up
Measured: 3 years
IMPACT program satisfaction for advanced practice nurse
IMPACT program satisfaction will be assessed by semi-structured interview with advanced practice nurse
Measured: 3 years
effectiveness of IMPACT program
Effectiveness of IMPACT program will be assessed by proportion of patients completing the proposed follow-up package
Measured: 3 years
Context of IMPACT program
Context of IMPACT program will be assessed with semi-structured interviews with advanced practice nurse which will evaluate factors favoring and hindering the implementation, the adaptation, the achievement and sustainbility of the IMPACT program
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start12 Apr 2024
- Primary completion28 Feb 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Elise VEROT, MD, Principal investigator, CHUSE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780762
- Sponsor's protocol ID
- 21GI262
- Other IDs
- ANSM
- Acronym
- IMPACT
- Status last verified
- Jun 2026
- First submitted
- 5 Dec 2022
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05780762
- Acronym / sponsor ID
- IMPACT / 21GI262
- Conditions
- Chronic Disease
- Keywords
- advanced practice nurse (APN), patient partnership, health literacy, self-management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 12 Apr 2024 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 23 Mar 2023 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMPACT program - experimental group | Experimental | Other: IMPACT Programpatients 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. |
| Usal care : control group | Sham comparator | Other: usal carepatients followed for one or several stabilized chronic pathology(ies) and benefiting from a usual management with a Nurse in Advanced Practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A patient receiving care from an advanced practice nurse (APN) for the management of one or more of the following chronic conditions: stroke; chronic arterial disease; heart disease, coronary artery disease; type 1 diabetes and type 2 diabetes; chronic respiratory failure; Parkinson's disease; epilepsy.
- Care provided by an IPA falls under one of the following categories:
- Either as direct care when the IPA practices within a healthcare facility, in accordance with current regulations, Or as care referred or prescribed by a physician when the IPA practices in private practice.
- 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
Key exclusion criteria (1 listed)
- A patient who is not under the care of a nurse practitioner under the conditions set forth in the Public Health Code (lack of authorized direct access or a required physician referral, depending on the practice model).
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 |
|---|---|---|
| IMPACT Programcare 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. | Other | IMPACT program - experimental group |
| usal careusual management with a Nurse in Advanced Practice. | Other | Usal care : control group |
Primary outcome
The patient/advanced practice nurse partnership
Time frame: At month 9
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.
9 secondary outcomes
The patient/advanced practice nurse partnership across the continuum of care
Time frame: baseline, 3 and 6 months
Perception of health-related quality of life
Time frame: At inclusion, 3, 6 and 9 months.
Health literacy level
Time frame: at inclusion, 3, 6 and 9 months
Impact of the quality of advanced practice nurse consultation from patient's perspective
Time frame: At baseline, 3, 6 and 9 months
Adoption of IMPACT program by advanced practice nurse
Time frame: 3 years
Participation in IMPACT program
Time frame: 3 years
IMPACT program satisfaction for advanced practice nurse
Time frame: 3 years
effectiveness of IMPACT program
Time frame: 3 years
Context of IMPACT program
Time frame: 3 years
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 10 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Elise VEROT, MD principal investigator
CHUSE
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMPACT Program and usal care in people with Chronic Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 5 sites in France.
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 5 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Elise VEROT, MD ((0)682309796 ext. +33, elise.verot@univ-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The patient/advanced practice nurse partnership (time frame: At month 9). 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 10 Jun 2026.