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

Last updated: May 14, 2018
Sponsor: University Hospital, Rouen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dementia

Mental Disability

Mild Cognitive Impairment

Treatment

N/A

Clinical Study ID

NCT03536975
2016/369/HP
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • For patients People, aged 50 and over, living in the community, who are able to giveinformed consent. Diagnosed with mild cognitive impairment (MCI) according to Petersen criteria or mild tomoderate dementia diagnosed according on DSM-IV criteria. Having a Clinical Dementia Rating (CDR) of 0.5 for MCI, 1-2 for mild to moderate dementiaHaving 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 alsoincluded in the study. Be willing to use Information Technology and Communications (ICT) according to theinvestigator criteria. Affiliated to the social security system.

  • For caregivers People, aged 18 years and over, with no diagnosis or no evidence ofmild 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 cognitiveimpairment or mild to moderate dementia People with Internet access and basic knowledge andskills in managing internet and social networks, or keen to learn, according to theinvestigator criteria Having a Geriatric Depression Scale (GDS-Yesavage - 15 items) scoreless than 11 at the time of entry into the trial indicating no severe depressive symptomsor for people < 50 years a MADRS < 15 Having no specific conditions (evaluated by theinvestigator) reducing their physical abilities below the norm for their age that wouldlimit or impair CAREGIVERSPRO-MMD platform use. Be willing to use Information Technology and Communications (ICT) according to theinvestigator criteria Affiliated to the social security system

Exclusion

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, thatmay interfere with the use of Information and Communications Technology (ICT) tools ;Under guardianship and/or under curatorship

Study Design

Total Participants: 200
Study Start date:
December 01, 2017
Estimated Completion Date:
December 31, 2018

Connect with a study center

  • Centre Hospitalier Intercommunal Elbeuf Louviers

    Elbeuf,
    France

    Active - Recruiting

  • Rouen University Hospital

    Rouen,
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.