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

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



Sponsors


Source

Assistance Publique Hopitaux De Marseille

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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

Overall Status

Not yet recruiting

Start Date

2018-02-02

Completion Date

2020-09-02

Primary Completion Date

2020-02-02

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

quality of life
Baseline

Secondary Outcome

Measure

Time Frame

Quality of life
6 months
self-administered questionnaires
6 months

Enrollment

350

Condition


Intervention

Intervention Type

Other

Intervention Name


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

Arm Group Label

access to the social network


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.

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Urielle DESALBRES
Study Director
Assistance Publique Hôpitaux de Marseille

Overall Contact

Last Name

Laurent BOYER

Phone

6 86 93 62 76

Phone Ext

+33

Email



Location

Facility

Status

Contact

Hôpital de la Conception
Marseille 13354 France
Not yet recruiting
Last Name: Laurent BOYER
Phone: 6 86 93 62 76
Phone Ext: +33
Email: [email protected]

Location Countries

Country

France


Verification Date

2017-11-01

Lastchanged Date

2017-11-09

Firstreceived Date

2017-11-08

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Arm Group

Arm Group Label

access to the social network

Arm Group Type

Experimental

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 Group Label

no access to the network

Arm Group Type

No Intervention

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.



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Xavier Zendjidjian

Phone

686936276

Phone Ext

+33

Email



Acronym

CONNECT

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Other

Masking

None (Open Label)


Study First Submitted

November 8, 2017

Study First Submitted Qc

November 9, 2017

Study First Posted

November 14, 2017

Last Update Submitted

November 9, 2017

Last Update Submitted Qc

November 9, 2017

Last Update Posted

November 14, 2017


ClinicalTrials.gov processed this data on November 14, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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