Identify the Benefits CAREGIVERSPRO-MMD Platform Use Based on the Information and Communications Technology, Dedicated to the Support and Assistance of Dyads Living With Neurocognitive Diseases and Their Primary Caregivers

NCT ID: NCT03536975

Last Updated: 2018-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2018-12-31

Brief Summary

Our main goal is to test a web platform accessible by computers, smartphones and tablets, addressed specifically to caregivers and people with mild cognitive deterioration or mild to moderate dementia providing added value services based on social networks, adapted interventions, clinic strategies and gamification to improve the quality of life of caregivers and people living with dementia (dyads) and permitting to leave in the community as long as possible.

To evaluate the platform effectiveness and impact in dementia type disease affected people and caregivers a randomized, controlled, parallel, longitudinal is proposed. The objective will be to assess during 18 months aspects related to health of individuals (general aspect of health, neuropsychological, daily living functionalities, quality of life, treatment adherence, comorbidities ...), social aspects (improving dyad relationship…) and economics (cost-effectiveness of platform utilization), as well as satisfaction degree and usability of platform.

Conditions

Cognitive Impairment, Mild; Dementia, Mild

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Platform

Group with access to the web platform "CAREGIVERSPRO-MMD"

Group Type: OTHER

Platform

Intervention Type: OTHER

The groups will be comprised of one "intervention" group with access to the web platform "CAREGIVERSPRO-MMD" and another "control" group without any access to it

Control

Group without any access to the web platform

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Platform

The groups will be comprised of one "intervention" group with access to the web platform "CAREGIVERSPRO-MMD" and another "control" group without any access to it

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• For patients People, aged 50 and over, living in the community, who are able to give informed consent.

Diagnosed with mild cognitive impairment (MCI) according to Petersen criteria or mild to moderate dementia diagnosed according on DSM-IV criteria.

Having a Clinical Dementia Rating (CDR) of 0.5 for MCI, 1-2 for mild to moderate dementia Having a Mini-Mental Exam score (MMSE) between 30 and 25 (inclusive) for MCI, and between 24 and 10 (inclusive) for dementia.

Having a primary caregiver, familiar (or not), informal (or not) identified and also included in the study.

Be willing to use Information Technology and Communications (ICT) according to the investigator criteria.

Affiliated to the social security system.

• For caregivers People, aged 18 years and over, with no diagnosis or no evidence of mild cognitive impairment or mild to moderate dementia (according DSM-IV criteria), who are able to give informed consent and with an intention to complete the study.

Primary caregivers, informal (or not), familiar (or not), of person with mild cognitive impairment or mild to moderate dementia People with Internet access and basic knowledge and skills in managing internet and social networks, or keen to learn, according to the investigator criteria Having a Geriatric Depression Scale (GDS-Yesavage - 15 items) score less than 11 at the time of entry into the trial indicating no severe depressive symptoms or for people < 50 years a MADRS < 15 Having no specific conditions (evaluated by the investigator) reducing their physical abilities below the norm for their age that would limit or impair CAREGIVERSPRO-MMD platform use.

Be willing to use Information Technology and Communications (ICT) according to the investigator criteria Affiliated to the social security system

Exclusion Criteria

• Terminal or severe illness with survival prognosis less than 18 months
• Not speaking nor reading French
• Enrolled in another clinical trial
• For the patients : Having delusions, hallucinations, behavioural disturbances, that may interfere with the use of Information and Communications Technology (ICT) tools ; Under guardianship and/or under curatorship

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Isabelle Landrin, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

Centre Hospitalier Intercommunal Elbeuf Louviers

Elbeuf, , France

Site Status: RECRUITING

Rouen University Hospital

Rouen, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Isabelle Landrin

Role: CONTACT

isabelle.landrin@chu-rouen.fr

33 2 32 88 6523

Facility Contacts

Thibault Simon, MD

Role: primary

Isabelle Landrin, MD

Role: primary

Other Identifiers

2016/369/HP

Identifier Type: -

Identifier Source: org_study_id