NCT04657380: PLAN-e-PSY

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

Status unknown NA Last updated 24 March 2022

What this trial tests

NA trial testing PLAN-e-PSY mobile application in Psychosis; Episode in 168 participants. Status unknown.

Timeline

4 December 2022

Primary endpoint
4 January 2024

4 January 2025

Quick facts

Lead sponsor	Hôpital le Vinatier
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	168
Start date	4 December 2022
Primary completion	4 January 2024
Estimated completion	4 January 2025
Sites	1 location across France

Drugs / interventions tested

• PLAN-e-PSY mobile application
• Control Group — full drug profile →

Conditions studied

• Psychosis; Episode — all drugs for Psychosis; Episode →

Sponsor

Hôpital le Vinatier — full company profile →

Who can join

Adults 18 to 30, any sex, with Psychosis; Episode. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Haesebaert F, El Oussoul S, Pavard A, Fabre D, et al · · 2021 · cited 3× · PMID 34521670 · DOI 10.1136/bmjopen-2021-050433