A Mobile Application to Improve Case-management and Patient's Functioning in First Episode Psychosis

NCT ID: NCT04657380

Last Updated: 2022-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-04
• Study Completion Date: 2025-01-04

Brief Summary

First Episode Psychosis (FEP) includes perceptual distortions, delusions and cognitive impairment with severe consequences, such as suicidal behaviour. It affects 3% of the population, mainly adolescents and young adults, the majority of with progress to a psychotic disorder.

The early stages of psychotic disorders, from the first full blown symptoms to the next two to five years, represent an opportunity to targeted care and prevention. Indeed, it is a critical period with a worsened clinical prognostic when intervention is delayed, increasing the duration of untreated psychosis (DUP). Also, it is a key period to reduce mortality, as it is characterized by elevated risks of suicide and low physical health outcomes. Besides the symptomatic components, this period is also critical for self-building on educational, professional and emotional levels.

Early intervention programmes involve multi-disciplinary teams, including a care coordination function, embodied by a "case manager". His missions include assessing the patient's needs, developing a care plan to meet the latter, organising access to the different components of the care plan, monitoring and evaluating care, and providing clinical follow-up.

Engagement in the care process is fragile in psychotic disorders, particularly in the context of first episode psychosis with a high risk of care disengagement, often associated with a relapse. It is therefore essential that case-managers involved in FEP services have access to tools designed according to the patient needs and not solely to symptoms, in a "recovery oriented" approach, to foster the feeling of commitment of patients in their care process.

The use of mobile applications for smartphones represents an interesting perspective to improve the engagement of patients with FEP in care. However, the use of an application focused on recovery is feasible and acceptable in patients with first episode psychosis enrolled in a specialised outpatient department (FEP-type service) and allows improvement on clinical criteria, such as psychotic symptoms or mood.

User-centred design methods including identification of users and an inventory of their needs, prototyping with rapid iterations, is a simplification of the procedure and exploitation of existing constraints to increase the rate of use. Moreover, it has recently been shown that such a methodology is feasible in populations with a first episode of psychosis.

Our hypothesis is that the use of a mobile case-management application for planning and monitoring individualised care objectives, co-designed with patients, their careers, and health professionals, improves the functioning of patients managed for a first psychotic episode, compared to usual case management practices.

The originality of our project is built up on two pillars :

• the use of a a mobile monitoring application, which will be used jointly by patients and case-managers,
• the methodological innovation also lies in the collaborative and patient-centred design of the application The originality of our project concerns on the one hand the intervention, an application mobile follow-up, which will be used jointly by patients and case managers. The innovative character also lies at the methodological level in the collaborative and patient-centered design of the application ('user-centered design' approach).

Detailed Description

Psychosis and early intervention First Episode Psychosis (FEP) includes perceptual distortions, delusions and cognitive impairment with severe consequences, such as suicidal behaviour. It affects 3% of the population, mainly adolescents and young adults, the majority of wish progress to a psychotic disorder.

From the first full blown symptoms to the next two to five years, the early stages of psychotic disorders represent an opportunity to targeted care and prevention. Indeed, it is a critical period with a worsened clinical prognostic when intervention is delayed, increasing the duration of untreated psychosis (DUP). Also, it Is a key period to reduce mortality, as it is characterized by elevated risks of suicide and low physical health outcomes. Besides the symptomatic components, this period is also critical for self-building on educational, professional and emotional levels.

A pejorative evolution can be avoided by the establishment of "early intervention in psychosis" (EIP), constituted by a set of integrated supports that allow to reduce the symptoms of the disease, promote recovery, foster better social and professional functioning. Moreover, it has recently been shown that EIP reduces general mortality including by suicide in the population monitored. In addition, medico-economic benefits of early intervention have been demonstrated in terms of direct and indirect costs. Thus, this intervention model is currently considered as the reference care in early intervention.

Case management: a strategy to promote recovery in early psychosis Early intervention programmes involve multi-disciplinary teams, including a care coordination function embodied by a "case manager". His missions include assessing the patient's needs, developing a care plan to meet the latter, organising access to the different components of the care plan, monitoring and evaluating care, and providing clinical follow-up. Those missions are broken down into several actions, the content is adapted to the duration of care according to the severity of the disorder and the level of remission.

Case management require essential qualities/ skills such as: accessibility, flexibility, optimism and competence. This model of intervention is effective for patients with FEP and is now considered as a "standard" of care for this population Psychosis and engagement in healthcare: a critical situation In psychotic disorders, the engagement in the care process is fragile, particularly in the context of first episode psychosis with a high risk of care disengagement, often associated with a relapse. Between 20 and 40% of patients with FEP disengage with care despite significant therapeutic needs. The relapse rate one year after stopping treatment ranges from 28% ( to 67% after a first episode of psychosis. Due to the complexity of factors involved in the engagement, it remains endlessly threatened despite better engagement rates in dedicated FEP services compared to "traditional/usual" care, of which the most important is the perception that the service is not adapted to their needs. It is therefore essential that case-managers involved in FEP services have access to tools designed according to the patient needs and not solely to symptoms, in a recovery-oriented approach, to foster the feeling of commitment of patients in their care process.

Mobile applications in mental health: a promising way to promote engagement in FEP services The use of mobile applications for smartphones represents an interesting perspective to improve the engagement of patients with FEP in care. Mobile mental health applications offer many possibilities: an appointment management, an information on the illness, a monitoring of symptoms, a deployment of psychotherapeutic techniques, etc… Mobile applications appear now as promising tools not only for better engagement in care, but also for better self-management capabilities and better coordination of resources. Recent data show an increase in the rate of smartphone equipment in the population of patients with psychosis (over 80%). Qualitative studies in this population show that this type of tools is in great demand, in particular to promote the bound between the patient and services and strengthen the self-management capacities.

Many of the recently implemented applications are aimed for in-patients with short evaluation periods, which does not allow longer term usage data. However, the use of an application focused on recovery is feasible and acceptable in patients with first episode psychosis enrolled in a specialised outpatient department FEP-type service) and allows improvement on clinical criteria, such as psychotic symptoms or mood.

Despite the fact that some applications specifically designed for FEP patients exist and have shown promising results, none have been developed in French and evaluated in French healthcare system. Moreover, anchoring the design of the application in recovery theory would make it possible to better align the actions resulting from the use of the application with the patient's needs.

User-centred design: a method suitable to build "recovery-oriented" tools User-centred design methods, initially developed for human-computer interactions are generally broken down into several phases, including identification of users and an inventory of their needs, prototyping with rapid iterations (i.e. a trial-and-error type strategy allowing rapid feedback from users), simplification of the procedure and exploitation of existing constraints to increase the rate of use. These approaches are particularly developed in the field of mobile application design because they make it possible to create a product that is closer to the concerns of the target person and is so particularly suitable for a "recovery-oriented" approach. Moreover, it has recently been shown that such a methodology is feasible in populations with a first episode of psychosis.

Research hypothesis Our hypothesis is that the use of a mobile case-management application for planning and monitoring individualised care objectives, co-designed with patients, their careers, and health professionals, improves the functioning of patients managed for a first psychotic episode, compared to usual case management practices

Conditions

Psychosis; Episode

Study Design

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

Study Groups

Usual case management practices

The first-episode psychosis services participating in the study offer case-management, which will correspond to the treatment as usual in the control group. All the centers are part of the National Transition Network (https://idpsy.org/reseau-transition/centres/). Involvement in this network ensures homogeneity of the usual practices which correspond to the internationally standards. Care delivery is based on intensive treatment during the critical period of psychosis, relying on a wide network of caring and non-caregiving professionals, working together with a view to the successful recovery of the patient. The patient and his or her family are at the center of care and receive proposals for psychoeducation and support throughout the different phases of the illness. This is concomitant with a regular evaluation of patients in order to update the care offer according to their clinical needs.

Group Type: ACTIVE_COMPARATOR

Control Group

Intervention Type: BEHAVIORAL

The first-episode psychosis services participating in the study offer case-management, which will correspond to the treatment as usual in the control group. All the centers are part of the National Transition Network (https://idpsy.org/reseau-transition/centres/). Involvement in this network ensures homogeneity of the usual practices which correspond to the internationally standards. Care delivery is based on intensive treatment during the critical period of psychosis, relying on a wide network

Mobile case-management application

The intervention tested will be a mobile application used during consultations involving the patient and the case manager to define care objectives. The mobile application to be evaluated will result from the process of a co-design phase based on the iterative "user-centered design" approach, involving representatives of carers, patients and caregivers. These stakeholders will define the content and form of the smartphone application during co-building workshops.

The main purpose of the final application will be to assist in the definition of patients' goals using an approach rooted in recovery theory, with the monitoring of goal achievement in three phases : 1) defining priorities for the patients, through a recovery oriented discussion with the patient and the case manager 2) Setting the concrete objectives and list concrete actions tho achieve them 3) evaluating the achievements.

Group Type: EXPERIMENTAL

PLAN-e-PSY mobile application

Intervention Type: BEHAVIORAL

The full version of the application to be evaluated will result from the process of co-design phase of the intervention based on the iterative "user-centered design" approach, involving representatives of carers, patients and caregivers, to define the content and form of the smartphone application during co-building workshops

Interventions

PLAN-e-PSY mobile application

The full version of the application to be evaluated will result from the process of co-design phase of the intervention based on the iterative "user-centered design" approach, involving representatives of carers, patients and caregivers, to define the content and form of the smartphone application during co-building workshops

Intervention Type: BEHAVIORAL

Control Group

The first-episode psychosis services participating in the study offer case-management, which will correspond to the treatment as usual in the control group. All the centers are part of the National Transition Network (https://idpsy.org/reseau-transition/centres/). Involvement in this network ensures homogeneity of the usual practices which correspond to the internationally standards. Care delivery is based on intensive treatment during the critical period of psychosis, relying on a wide network

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Men and women aged between 18 and 30 years old enrolled in a specialised FEP service for a first psychotic episode, defined as follows:

Presence of daily psychotic symptoms for more than a week that have been characterised at the clinical examination by a psychiatrist, Initiation of antipsychotic treatment for less than 6 months, A diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder or brief psychotic disorder established according to DSM-5 criteria.

• Mastery of the French language (read and spoken)
• Owning a smartphone
• Adult patients who have given written consent

Exclusion Criteria

• Patients in psychiatric intensive care units because of severe agitation/disorganisation.
• Patients under guardianship

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital le Vinatier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederic HAESEBAERT, PH

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier le Vinatier

Locations

Ch Le Vinatier

Lyon, Auvergne-Rhône-Alpes, France

Countries

France

Central Contacts

Frederic HAESEBAERT, Ph

Role: CONTACT

frederic.haesebaert@ch-le-vinatier.fr

00 (33) 437 915 565

Lydie SARTELET

Role: CONTACT

lydie.sartelet@ch-le-vinatier.fr

437915531 ext. +33

Facility Contacts

HAESEBAERT FREDERIC, PH

Role: primary

frederic.haesebaert@ch-le-vinatier.fr

0033437914922

Lydie SARTELET

Role: backup

lydie.sartelet@ch-le-vinatier.fr

0033437915531

References

Haesebaert F, El Oussoul S, Pavard A, Fabre D, Cellard C, Magaud L, Subtil F, Damiolini E, Fakra E, Haesebaert J. PLAN-e-PSY, a mobile application to improve case management and patient's functioning in first episode psychosis: protocol for an open-label, multicentre, superiority, randomised controlled trial. BMJ Open. 2021 Sep 14;11(9):e050433. doi: 10.1136/bmjopen-2021-050433.

Reference Type: DERIVED

PMID: 34521670 (View on PubMed)

Other Identifiers

PHRCI19FH

Identifier Type: -

Identifier Source: org_study_id