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

NCT04657380 | Unknown

• 1 other identifier: PHRCI19FH
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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).

Conditions

Psychosis; Episode

Keywords

FEP; case management; smartphone application; User-centered design; Mixed method; RCT

Outcome Measures

Primary Outcomes (1)

• Personal and Social Performance (PSP) scale

  Variation in the patient's functioning score measured by the "Personal and Social Performance (PSP)" scale, informed by a psychiatrist, trained in the use of the scale, not directly involved in the patient's follow-up and blinded to the patient's randomisation group. This hetero-evaluative scale, available in French, assesses functioning in a single score that takes into account four domains: productive social activities (work/study), social network, personal care, and disruptive or aggressive behaviour. The integrative score ranges from 0 to 100, with higher scores reflecting better functioning. Functioning corresponds to an individual's capacity to assume his or her social role, in the domestic, professional or school, emotional, family and friendship spheres. This is the final objective of case-managed FEPs.

  Between inclusion and 12 months

Secondary Outcomes (15)

• Evolution of the Personal and Social Performance Scale PSP

  Between inclusion and 6 months and between inclusion and 12 months

• Therapeutic alliance

  Between inclusion and 6 months and between inclusion and 12 months

• Adherence to drug treatment

  Between inclusion and 6 months and between inclusion and 12 months

• Psychotic symptomatology

  Between inclusion and 6 months and between inclusion and 12 months

• Recovery

  Between inclusion and 6 months and between inclusion and 12 months

Study Arms (2)

Usual case management practices

ACTIVE COMPARATOR

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.

Behavioral: Control Group

Mobile case-management application

EXPERIMENTAL

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.

Behavioral: PLAN-e-PSY mobile application

Interventions

PLAN-e-PSY mobile application 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

Mobile case-management application

Control Group 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

Usual case management practices

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (1)

Ch Le Vinatier

Lyon, Auvergne-Rhône-Alpes, 69678, France

Location

Related Publications (1)

• 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.

  PMID: 34521670 DERIVED

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Frederic HAESEBAERT, PH

  Centre Hospitalier le Vinatier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frederic HAESEBAERT, Ph

CONTACT

00 (33) 437 915 565; frederic.haesebaert@ch-le-vinatier.fr

Lydie SARTELET

CONTACT

437915531; lydie.sartelet@ch-le-vinatier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Randomisation 1/1 comparing an early intervention program "standard "and an" extended "program within a specialized team will be carried out by IWRS (ENNOV Clinical solution) using the swapped block method. A stratification will be carried out on the case-manager. There is no blinding for the patient or the case-manager. Nevertheless, the evaluation of the comparative outcomes between the 2 groups will be carried out by a psychiatrist who is not involved in the patient's follow-up and who will be blinded to the patient's group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 8, 2020
• Study Start: December 4, 2022
• Primary Completion: January 4, 2024
• Study Completion: January 4, 2025
• Last Updated: March 24, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)