Evaluation of the Impact of a Social Network Via a Digital Platform for Caregivers of Patients Suffering From Mental Disorders (CONNECT)
Primary Purpose
Mental Illness
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
access to the social network
Sponsored by
About this trial
This is an interventional other trial for Mental Illness
Eligibility 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.
Sites / Locations
- Hôpital de la Conception
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
access to the social network
no access to the network
Arm Description
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 )
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
self-administered questionnaires
Zarit's scale
Full Information
NCT ID
NCT03342248
First Posted
November 8, 2017
Last Updated
November 9, 2017
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT03342248
Brief Title
Evaluation of the Impact of a Social Network Via a Digital Platform for Caregivers of Patients Suffering From Mental Disorders
Acronym
CONNECT
Official Title
Evaluation of the Impact of a Social Network Via a Digital Platform for Caregivers of Patients Suffering From Mental Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2, 2018 (Anticipated)
Primary Completion Date
February 2, 2020 (Anticipated)
Study Completion Date
September 2, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Illness
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
access to the social network
Arm Type
Experimental
Arm Description
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 )
Arm Title
no access to the network
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
access to the social network
Intervention Description
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
Primary Outcome Measure Information:
Title
quality of life
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Quality of life
Description
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.
Time Frame
6 months
Title
self-administered questionnaires
Description
Zarit's scale
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurent BOYER
Phone
6 86 93 62 76
Ext
+33
Email
laurent.boyer@ap-hm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Xavier Zendjidjian
Phone
686936276
Ext
+33
Email
xavier.zendjidjian@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urielle DESALBRES
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital de la Conception
City
Marseille
ZIP/Postal Code
13354
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent BOYER
Phone
6 86 93 62 76
Ext
+33
Email
laurent.boyer@ap-hm.fr
12. IPD Sharing Statement
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Evaluation of the Impact of a Social Network Via a Digital Platform for Caregivers of Patients Suffering From Mental Disorders
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