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

Mental Illness Clinical Trial

— CONNECT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03342248
• Other study ID #: 2017-17
• Status: Not yet recruiting
• Phase: N/A
• First received: November 8, 2017
• Last updated: November 9, 2017
• Start date: February 2, 2018
• Est. completion date: September 2, 2020

Study information

• Verified date: November 2017
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Laurent BOYER
• Phone: 6 86 93 62 76
• Email: laurent.boyer[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: September 2, 2020
• Est. primary completion date: February 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Mental Illness
• Psychotic Disorders

Intervention

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

Locations

Country	Name	City	State
France	Hôpital de la Conception	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	6 months
Secondary	self-administered questionnaires	Zarit's scale	6 months