CONNECT: Evaluation of the Impact of a Social Network Via a Digital Platform for Caregivers of Patients Suffering From Mental Disorders

Sponsor
Assistance Publique Hopitaux De Marseille (Other)
Overall Status
Unknown status
CT.gov ID
NCT03342248
Collaborator
(none)
350
1
2
31
11.3

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: access to the social network
N/A

Detailed Description

This project will take place in three stages:

1- Development and development of the network: the conception of the social network is based on the point of view of the caregivers, which is one of the originalities of this project. Current social networks are very "medico-centric" And often poorly adapted to the needs of caregivers of patients suffering from pathologies mental disorders. This step is based on a qualitative approach to these caregivers. Focus groups (5 focus of 5 carers) will be led by a psychologist in order to understand their experience and identify the resulting needs in order to determine the architecture and services offered on the network social. From emerging needs, a study based on Delphi method will be conducted with professionals from different disciplines psychiatry, public health, communication and information professionals, ethicists, health economists and sociologists) to provide a light on the professional responses that can be proposed to the needs of carers. The development of the social network will be done in close collaboration with a caregiver who will be in charge of the animation and moderation of the network 2. Implementation of the randomized trial comparing two groups of caregivers (access to the social network vs. lack of access to the social network) over a period of 6 month. The same scales will be filled by both groups at T0 and then at 6 months.

  1. Qualitative approach to network perception: semidirective interviews made by a psychologist to a panel of caregivers using the network at course of 6 months

Study Design

Study Type:
Interventional
Anticipated Enrollment :
350 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Evaluation of the Impact of a Social Network Via a Digital Platform for Caregivers of Patients Suffering From Mental Disorders
Anticipated Study Start Date :
Feb 2, 2018
Anticipated Primary Completion Date :
Feb 2, 2020
Anticipated Study Completion Date :
Sep 2, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: access to the social network

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
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

No Intervention: no access to the network

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.

Outcome Measures

Primary Outcome Measures

  1. quality of life [Baseline]

    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.

Secondary Outcome Measures

  1. Quality of life [6 months]

    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.

  2. self-administered questionnaires [6 months]

    Zarit's scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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.

Exclusion Criteria:
  • Minors caregivers

  • not speaking and not reading enough French to participate in the study

  • not having agreed to participate in the study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital de la Conception Marseille France 13354

Sponsors and Collaborators

  • Assistance Publique Hopitaux De Marseille

Investigators

  • Study Director: Urielle DESALBRES, Assistance Publique Hôpitaux de Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT03342248
Other Study ID Numbers:
  • 2017-17
First Posted:
Nov 14, 2017
Last Update Posted:
Nov 14, 2017
Last Verified:
Nov 1, 2017
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 14, 2017