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

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ClinicalTrials.gov Identifier: NCT03342248
Recruitment Status : Not yet recruiting
First Posted : November 14, 2017
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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
Mental Illness Other: access to the social network Not Applicable

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.

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


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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : February 2, 2018
Estimated Primary Completion Date : February 2, 2020
Estimated Study Completion Date : September 2, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. quality of life [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 months ]
    Zarit's scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03342248


Contacts
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Contact: Laurent BOYER 6 86 93 62 76 ext +33 laurent.boyer@ap-hm.fr
Contact: Xavier Zendjidjian 686936276 ext +33 xavier.zendjidjian@ap-hm.fr

Locations
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France
Hôpital de la Conception Not yet recruiting
Marseille, France, 13354
Contact: Laurent BOYER    6 86 93 62 76 ext +33    laurent.boyer@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Urielle DESALBRES Assistance Publique Hôpitaux de Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03342248     History of Changes
Other Study ID Numbers: 2017-17
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders