NCT03342248

Brief Summary

Severe mental illnesses have a significant social cost, as much by their impact on the sick as on their entourage. The Deinstitutionalization and care in the community of patients with severe mental illness result in increased families and loved ones (also known as "informal caregivers" or "informal caregivers") If psychoeducation programs have been developed to help caregivers better manage and cope with the illness of the person being helped (optimize the quality of care, manage anxiety and isolation, these initiatives appear minimal in view of the magnitude of the burden (notion of burden: "burden") and the suffering of caregivers. Quality of life levels remain extremely low compared to the general population, nearly 4 out of 10 caregivers show a sense of inability to cope with the "permanent anxiety" of this load, 1/3 feels depressed and over 1/10 feels isolated on a personal and professional level

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

February 2, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2020

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

2 years

First QC Date

November 8, 2017

Last Update Submit

November 9, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • quality of life

    The quality of life of caregivers is assessed using a specific questionnaire , validated, designed to measure the quality of life of caregivers. caregivers of patients suffering from mental pathology: the CGSQoL (Auquier 2013). This questionnaire has satisfactory psychometric properties and is sensitive to change.

    Baseline

Secondary Outcomes (2)

  • Quality of life

    6 months

  • self-administered questionnaires

    6 months

Study Arms (2)

access to the social network

EXPERIMENTAL

This group is made up of carers who have access to the social network via a digital platform developed during step 1. This network will offer features from step 1 (sharing experiences on a forum, monitoring health status )

Other: access to the social network

no access to the network

NO INTERVENTION

This group consists of caregivers who do not have access to the social network via a digital platform developed during step 1. Access to the social network will be offered to all carers at the end of the study, especially those assigned in the control group to limit their refusal to participate.

Interventions

The development of a social network via a digital platform for carers of patients suffering from severe mental illness and study of the impact of its use on the health status of caregivers

access to the social network

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Caregiver of patient suffering from a severe mental illness and consultant in one of the investigative centers
  • over 18 years old
  • Caregiver who has no problem understanding current French Careguiver who has agreed to participate in the study. The definition of the caregiver is that given by the High Authority of Health (HAS): The so-called natural caregivers are the unprofessional people who come to the help of a person dependent on his entourage for the activities of daily life.

You may not qualify if:

  • Minors caregivers
  • not speaking and not reading enough French to participate in the study
  • not having agreed to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital de la Conception

Marseille, 13354, France

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Urielle DESALBRES

    Assistance Publique Hôpitaux de Marseille

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2017

First Posted

November 14, 2017

Study Start

February 2, 2018

Primary Completion

February 2, 2020

Study Completion

September 2, 2020

Last Updated

November 14, 2017

Record last verified: 2017-11

Locations