First Episode Psychosis (FEP)APIPEPNCT07041463
Psychoeducation Program for Family Caregivers Coordinated by an APRN
A study testing Psychoeducation program coordinated by an APRN in people with First Episode Psychosis (FEP) and Caregiver Burden, run by Hôpital le Vinatier at 5 sites in France.
Trial summary
The aim of this study is to assess the impact of implementing a specific family program coordinated by APRNs, covering the 5 levels of the family care pyramid through a consultation, an individual psychoeducation program and a group psychoeducation program, on improving caregiver burden and thus contributing to the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- First Episode Psychosis (FEP), Caregiver Burden, Nurse Practitioners
- What is being tested?
- Psychoeducation program coordinated by an APRN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 5 sitesFrance
- Study dates
- 5 Jun 2026to 4 Nov 2030
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caregiver relative of a patient under the care of the FEP team and meeting the criteria of international recommendations of FEP diagnosis made by the specialized team of less than 6 months, between 18 and 35 years of age.
- Caregiver having received information about the study and having giveń consent.
- Caregiver covered by a health insurance plan
Who cannot join
- Caregiver under curatorship, guardianship, safeguard of justice, family habilitation or future protection mandate
- Caregiver participating in another study that may interact with this one
- Caregiver not fluent in French (comprehension/reading)
- Caregiver who has already received psycho-education on FEP
- Patient's opposition to caregiver's participation in research
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
CHRU de Brest - Hôpital de BOHARS,
Bohars, 29820
Lucie DUSSAUZE, Nurse, 0607060398 ext. +33, lucie.dussauze@chu-brest.fr
Lucie DUSSAUZE, Nurse
- Recruiting
CH le Vinatier
Bron, 69678
Caroline DAMASCENO, 07 85 58 68 10 ext. +33, caroline.damasceno@ch-le-vinatier.fr
Caroline DAMASCENO
- Not yet recruiting
Groupe Hospitalier Marius Lacroix
La Rochelle, 17000
Hugues MONJARET, Nurse, 07 89 29 08 75 ext. +33, Hugues.monjaret@ght-atlantique17.fr
Hugues MONJARET
- Not yet recruiting
Hôpital La Colombière
Montpellier, 34295
Nathalie FOURNIER, Nurse, 0616740672 ext. +33, ice-uja@chu-montpellier.fr
Nathalie FOURNIER, Nurse
- Not yet recruiting
CHU de Nîmes
Nîmes, 30029
NAdia LIPPLER, Nurse, 0466686868 ext. +33, nadia.LIPPLER@chu-nimes.fr
Nadia LIPPLER, Nurse
About this study
Official title: Impact of a New Psychoeducation Program Coordinated by an Advanced Practce Nurse on the Burden of Family Caregivers of Patients With a First Pyschotic Episode.
The aim of this study is to assess the impact of implementing a specific family program coordinated by APRNs, covering the 5 levels of the family care pyramid through a consultation, an individual psychoeducation program and a group psychoeducation program, on improving caregiver burden and thus contributing to the recovery of users suffering from FEP.
Detailed Description: Psychotic disorders are among the most disabling chronic pathologies in psychiatry. These disorders modify the individual's perceptions, thoughts, moods, behaviours and day-to-day functioning (Implementing interventions as early as possible in the first psychotic episode (FEP) would be likely to decrease the severity and consequences of the illness and improve prospects for recovery. Evidence supports the establishment of multidisciplinary teams to detect early and treat early those experiencing FEP and those at increased risk of psychosis. Recommended interventions include cognitive-behavioral therapies, family interventions, employment and educational support, and above all, at the heart of the system, case management. These specialized teams need to be multidisciplinary, bringing together psychiatrists, psychologists and social workers in addition to case managers. More recently in France, Advanced practice nurse (APRN) have joined these teams. But getting young people to accept both disorders and care is a difficult necessity, and remains a major challenge. Poor compliance with treatment is said to be one of the primary causes of relapse after FEP. Factors that increase the risk of relapse include initially more severe symptoms, persistent substance abuse, poor adherence to treatment and inadequate support from family and friends. Nowadays, support from a close caregiver for a person living with a psychic disorder is recognized as a very favorable factor for long-term prognosis. But the occurrence of a FEP often has the effect of a tidal wave for loved ones, who present high levels of psychological distress and feelings of burden. Unfortunately, it is still difficult for families to gain access to family caregiver support services, which are still insufficiently available and often unknown to them. A number of barriers stand in the way of systematically proposing family interventions, such as health professionals' lack of awareness of the effectiveness of interventions aimed at family carers, their difficulty in establishing a double therapeutic alliance with the young person and his or her family, or the misperception that family interventions are in contradiction with professional secrecy.
The pyramid of family care in early intervention presents the family support that should be available to families of young people with FEP. The levels of intervention are designed to meet the support needs of family caregivers and can be used flexibly depending on specific needs or the phase of the psychotic episode. Also, APRNs could contribute to the success of these caregiver support programs thanks to their skills in prevention, assessment and coordination of complex pathways. This study therefore aims to determine the extent to which a specific program coordinated by APRNs can influence the burden of a family caregiver of a young person suffering from FEP.
Read the detailed description
Implementing a specific family program coordinated by APRNs, covering the 5 levels of the family care pyramid through a consultation, an individual psychoeducation program and a group psychoeducation program, on improving caregiver burden and thus contributing to the recovery of users suffering from FEP.
- Conditions
- First Episode Psychosis (FEP), Caregiver Burden, Nurse Practitioners, IMPACT OF A NEW PSYCHOEDUCATION PROGRAM COORDINATED BY AN ADVANCED PRACTICE NURSE ON THE BURDEN OF FAMILY CAREGIVERS OF PATIENTS WITH A FIRST PSYCHOTIC EPISODE
- Being tested
- Psychoeducation program coordinated by an APRN, Usual Care
- Keywords
- First Episode Psychosis (FEP), Caregiver burden, Advanced Practice Nurse
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducation program coordinated by an APRNOther
Individual and group psycho-education programs. Each investigating center will be trained in the same tools, in order to harmonize practices:
- BREF: This is a 3-session psycho-educational program in which each family is received individually by a pair of caregivers who are not involved in the patient's care.
- PEPs Caregiver: This is a group psycho-education program in 5 2-hour sessions developed in the coordinating center.
Usual CareOther
The caregiver will benefit from the interventions and referrals provided for caregivers "as usual" at each center.
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducation program coordinated by an APRN | Experimental | The intervention includes an APRN reception, listening and orientation consultation, harmonized during a preparatory meeting prior to setting up the study. At the very least, this should include empathetic listening to the young person's problems, a tour of the unit, an explanation of the young person's background and an explanation of the approach.
* Individual and group psycho-education programs. Each investigating center will be trained in the same tools, in order to harmonize practices:
* BREF: This is a 3-session psycho-educational program in which each family is received individually by a pair of caregivers who are not involved in the patient's care.
* PEPs Caregiver: This is a group psycho-education program in 5 2-hour sessions developed in the coordinating center. Receives: Other: Psychoeducation program coordinated by an APRN; Other: Usual Care |
| USUAL intervention | Other | The intervention includes an APRN reception, listening and orientation consultation, harmonized during a preparatory meeting prior to setting up the study. At the very least, this should include empathetic listening to the young person's problems, a tour of the unit, an explanation of the young person's background and an explanation of the approach.
In the control phase, the caregiver will benefit from the interventions and referrals provided for caregivers "as usual" at each center. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver's burden
The ZARIT scale is a validated, self-reported questionnaire that assesses the emotional, physical and financial burden of caring for a sick person. It consists of 22 items, with response modalities on a Likert scale), rated from 0 to 4, giving a score from 0 to 88. A low score represents a limited level of perceived burden, while a high score reflects a heavy burden.
Measured: 2 times : Baseline and at 6 months
Secondary outcomes (14)
Caregiver's burden
Change in ZARIT score of caregiver between inclusion and 3 months, between inclusion and 12 months the same as primary outcome measure
Measured: 2 times : at 3 months and at 12 months
The mood of the caregiver
The CES-D (center of epidemiologic studies depression) scale is a self-administered questionnaire that assesses the subject's mood by asking how often, in the past week, he or she has experienced symptoms or behaviors associated with depression. Symptom frequency is measured using a 4-point Likert scale (0=never to 3=frequently). The overall score ranges from 0 to 60. Higher scores correspond to more severe symptoms
Measured: 4 times : at inclusion, at 3 months, at 6 months and at 12 months
The caregiver's personal effectiveness
General Self-Efficacy Scale GSE French version. This is a self-administered questionnaire where each statement refers to a successful adaptation and implies a stable internal attribution of success. It uses a 1-4 response scale of "Not at all true" "Barely true", "Moderately true" and "Totally true". The total score is calculated by adding up the responses to each statement: it can therefore vary from 10 to 40.
Measured: 4 times : at inclusion, at 3 months, at 6 months and at 12 months
Quality of life for caregivers
The World Health Organization Quality of Life WHOQOL-BREF. This 26-item questionnaire is completed by the respondent. It comprises 4 domains: "physical health", "psychological well-being", "social relationships" and "environment". Items are answered using a five-level scale (from "not at all" to "rather no", 'about', "most of the time" to "completely"). The scales are highly internally consistent.
Measured: 2 times : at inclusion, at 12 months
Involvement in patient care
The Service Engagement Scale SES. This is a 14-point measure that assesses service-user engagement from the staff's point of view. The case manager involved in the service user's care assesses his or her agreement with the statements using a four-point Likert scale about the user's availability, collaboration with the user, help-seeking and adherence to treatment.
Measured: 2 times : at inclusion, at 12 months
User recovery
The Stages Of Recovery Instrument STORI. This self-administered questionnaire assesses the stage of recovery reached by a patient with a psychotic disorder. The STORI is made up of 50 items, presented in 10 groups of 5. Each group represents one of the four recovery processes (Hope, Identity, Meaning, Responsibility).
Measured: 2 times : at inclusion, at 12 months
Implementation of the intervention
Acceptability: rate of acceptance of participation in the study by family caregivers, number of refusals and early stops in the program, proportion of family caregivers benefiting from the entire program
Measured: 1 time : at 12 months
Acceptance of study participation
Acceptance of study participation by caregivers will be measured by the proportion of caregivers who agreed to participate in the study among those who were offered the study
Measured: 1 time : at 12 months
Feasibility of the program
Feasibility of the program will be measured by the average length of time between stages of the program
Measured: 1 time at 12 months
qualitative evaluation of the implementation
qualitative evaluation of the implementation during semi-structured interviews with the APRNs at each center and the family caregivers in the experimental group. This qualitative survey will enable us to determine satisfaction with the program, understand the perceived effects of the program and its acceptability, and explore the perceived obstacles and limitations of the program and its implementation. These elements will be studied at both individual (caregivers, users and professionals) and organizational (services, environment) levels. The posture, missions and role of the APRNs with patients, families and within the FEP team will be studied in semi-directed interviews.
Measured: 1 time : at 12 months
Program transferability
Program transferability (the extent to which the effects of an intervention in one context can be observed in another) will be analyzed using the Tool for Analyzing Transferability and Supporting the Adaptation of Health Promotion InteRventions (ASTAIRE Grid). This tool assesses the transferability of an intervention based on the characteristics of the target population, the environment in which the intervention is implemented and the support required for transfer
Measured: 1 time : at 12 months
The relapse
Relapse will be defined as any general worsening of the person's condition (decline in level of functioning) requiring intervention such as hospitalization, day hospital follow-up or mobile team intervention for the duration of study participation
Measured: 1 time : at 12 months
Adherence to the program
Adherence to the program will be measured by the percentage of participants who completed the program among all caregivers included.
Measured: 1 time : at 12 months
The fidelity of the program
The fidelity of the program delivered will be measured by the number of sessions of the program delivered compared with the initial program.
Measured: 1 time at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start5 Jun 2026
- Primary completion4 Nov 2030 (estimated)
- Study completion4 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for First Episode Psychosis (FEP)Studies 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
- Model description
- Multicenter randomized controlled stepped wedge cluster trial
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041463
- Sponsor's protocol ID
- 2025-A00412-47
- Other IDs
- PHRIP-22-0039
- Acronym
- APIPEP
- Status last verified
- Jun 2026
- First submitted
- 28 May 2025
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Caroline D, Julie H, Fabien S, Romain R, Frederic H. Reducing Caregiver Burden in First-Episode Psychosis: Effects of a Psychoeducational Pathway Led by an Advanced Practice Nurse-A Multicentre Stepped-Wedge Randomized Trial. Int J Ment Health Nurs. 2026 Oct;35(5):e70373. doi: 10.1111/inm.70373.
PubMed 42861836
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a New Psychoeducation Program Coordinated by an Advanced Practce Nurse on the Burden of Family Caregivers of Patients With a First Pyschotic Episode.
- ClinicalTrials.gov ID
- NCT07041463
- Acronym / sponsor ID
- APIPEP / 2025-A00412-47
- Conditions
- First Episode Psychosis (FEP), Caregiver Burden, Nurse Practitioners, IMPACT OF A NEW PSYCHOEDUCATION PROGRAM COORDINATED BY AN ADVANCED PRACTICE NURSE ON THE BURDEN OF FAMILY CAREGIVERS OF PATIENTS WITH A FIRST PSYCHOTIC EPISODE
- Keywords
- First Episode Psychosis (FEP), Caregiver burden, Advanced Practice Nurse
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 5 Jun 2026 (actual)
- Primary completion
- 4 Nov 2030 (estimated)
- Study completion
- 4 Nov 2030 (estimated)
- First posted
- 27 Jun 2025 (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 aim of this study is to assess the impact of implementing a specific family program coordinated by APRNs, covering the 5 levels of the family care pyramid through a consultation, an individual psychoeducation program and a group psychoeducation program, on improving caregiver burden and thus contributing to the recovery of users suffering from FEP.
Detailed Description: Psychotic disorders are among the most disabling chronic pathologies in psychiatry. These disorders modify the individual's perceptions, thoughts, moods, behaviours and day-to-day functioning (Implementing interventions as early as possible in the first psychotic episode (FEP) would be likely to decrease the severity and consequences of the illness and improve prospects for recovery. Evidence supports the establishment of multidisciplinary teams to detect early and treat early those experiencing FEP and those at increased risk of psychosis. Recommended interventions include cognitive-behavioral therapies, family interventions, employment and educational support, and above all, at the heart of the system, case management. These specialized teams need to be multidisciplinary, bringing together psychiatrists, psychologists and social workers in addition to case managers. More recently in France, Advanced practice nurse (APRN) have joined these teams. But getting young people to accept both disorders and care is a difficult necessity, and remains a major challenge. Poor compliance with treatment is said to be one of the primary causes of relapse after FEP. Factors that increase the risk of relapse include initially more severe symptoms, persistent substance abuse, poor adherence to treatment and inadequate support from family and friends. Nowadays, support from a close caregiver for a person living with a psychic disorder is recognized as a very favorable factor for long-term prognosis. But the occurrence of a FEP often has the effect of a tidal wave for loved ones, who present high levels of psychological distress and feelings of burden. Unfortunately, it is still difficult for families to gain access to family caregiver support services, which are still insufficiently available and often unknown to them. A number of barriers stand in the way of systematically proposing family interventions, such as health professionals' lack of awareness of the effectiveness of interventions aimed at family carers, their difficulty in establishing a double therapeutic alliance with the young person and his or her family, or the misperception that family interventions are in contradiction with professional secrecy.
The pyramid of family care in early intervention presents the family support that should be available to families of young people with FEP. The levels of intervention are designed to meet the support needs of family caregivers and can be used flexibly depending on specific needs or the phase of the psychotic episode. Also, APRNs could contribute to the success of these caregiver support programs thanks to their skills in prevention, assessment and coordination of complex pathways. This study therefore aims to determine the extent to which a specific program coordinated by APRNs can influence the burden of a family caregiver of a young person suffering from FEP.
Detailed description
Implementing a specific family program coordinated by APRNs, covering the 5 levels of the family care pyramid through a consultation, an individual psychoeducation program and a group psychoeducation program, on improving caregiver burden and thus contributing to the recovery of users suffering from FEP.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter randomized controlled stepped wedge cluster trial
| Arm | Type | Receives |
|---|---|---|
| Psychoeducation program coordinated by an APRN | Experimental | Other: Psychoeducation program coordinated by an APRN, Other: Usual CareThe intervention includes an APRN reception, listening and orientation consultation, harmonized during a preparatory meeting prior to setting up the study. At the very least, this should include empathetic listening to the young person's problems, a tour of the unit, an explanation of the young person's background and an explanation of the approach. * Individual and group psycho-education programs. Each investigating center will be trained in the same tools, in order to harmonize practices: * BREF: This is a 3-session psycho-educational program in which each family is received individually by a pair of caregivers who are not involved in the patient's care. * PEPs Caregiver: This is a group psycho-education program in 5 2-hour sessions developed in the coordinating center. |
| USUAL intervention | Other | Other: Usual CareThe intervention includes an APRN reception, listening and orientation consultation, harmonized during a preparatory meeting prior to setting up the study. At the very least, this should include empathetic listening to the young person's problems, a tour of the unit, an explanation of the young person's background and an explanation of the approach. In the control phase, the caregiver will benefit from the interventions and referrals provided for caregivers "as usual" at each center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Caregiver relative of a patient under the care of the FEP team and meeting the criteria of international recommendations of FEP diagnosis made by the specialized team of less than 6 months, between 18 and 35 years of age.
- Caregiver having received information about the study and having giveń consent.
- Caregiver covered by a health insurance plan
Key exclusion criteria (5 listed)
- Caregiver under curatorship, guardianship, safeguard of justice, family habilitation or future protection mandate
- Caregiver participating in another study that may interact with this one
- Caregiver not fluent in French (comprehension/reading)
- Caregiver who has already received psycho-education on FEP
- Patient's opposition to caregiver's participation in research
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 |
|---|---|---|
| Psychoeducation program coordinated by an APRNIndividual and group psycho-education programs. Each investigating center will be trained in the same tools, in order to harmonize practices: * BREF: This is a 3-session psycho-educational program in which each family is received individually by a pair of caregivers who are not involved in the patient's care. * PEPs Caregiver: This is a group psycho-education program in 5 2-hour sessions developed in the coordinating center. | Other | Psychoeducation program coordinated by an APRN |
| Usual CareThe caregiver will benefit from the interventions and referrals provided for caregivers "as usual" at each center. | Other | Psychoeducation program coordinated by an APRN, USUAL intervention |
Primary outcome
Caregiver's burden
Time frame: 2 times : Baseline and at 6 months
The ZARIT scale is a validated, self-reported questionnaire that assesses the emotional, physical and financial burden of caring for a sick person. It consists of 22 items, with response modalities on a Likert scale), rated from 0 to 4, giving a score from 0 to 88. A low score represents a limited level of perceived burden, while a high score reflects a heavy burden.
14 secondary outcomes
Caregiver's burden
Time frame: 2 times : at 3 months and at 12 months
The mood of the caregiver
Time frame: 4 times : at inclusion, at 3 months, at 6 months and at 12 months
The caregiver's personal effectiveness
Time frame: 4 times : at inclusion, at 3 months, at 6 months and at 12 months
Quality of life for caregivers
Time frame: 2 times : at inclusion, at 12 months
Involvement in patient care
Time frame: 2 times : at inclusion, at 12 months
User recovery
Time frame: 2 times : at inclusion, at 12 months
Implementation of the intervention
Time frame: 1 time : at 12 months
Acceptance of study participation
Time frame: 1 time : at 12 months
Feasibility of the program
Time frame: 1 time at 12 months
qualitative evaluation of the implementation
Time frame: 1 time : at 12 months
Program transferability
Time frame: 1 time : at 12 months
The relapse
Time frame: 1 time : at 12 months
Adherence to the program
Time frame: 1 time : at 12 months
The fidelity of the program
Time frame: 1 time at 12 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 9 Jun 2026.
- Derived from this study: PubMed 42861836Caroline D, Julie H, Fabien S, Romain R, Frederic H. Reducing Caregiver Burden in First-Episode Psychosis: Effects of a Psychoeducational Pathway Led by an Advanced Practice Nurse-A Multicentre Stepped-Wedge Randomized Trial. Int J Ment Health Nurs. 2026 Oct;35(5):e70373. doi: 10.1111/inm.70373.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation program coordinated by an APRN in people with First Episode Psychosis (FEP) and Caregiver Burden, run by Hôpital le Vinatier 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 3 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: looking for participants now, as of the sponsor's last update on 9 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. 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 Caroline DAMASCENO, Nurse (07 85 58 68 10 ext. +33, caroline.damasceno@ch-le-vinatier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver's burden (time frame: 2 times : Baseline and at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07041463, which also lists 1 linked publication.
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 9 Jun 2026.