Clinical trial NCT03536975: 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
Official title: Pilot Study to 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 Including Persons Living With Mild Cognitive Impairment or Mild to Moderate Dementia and Their Primary Caregivers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Impairment, Mild
Dementia, Mild
Keywords: Dementia
Mild Dementia
Cognitive Impairment
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Intercommunal Elbeuf-Louviers / Val de Reuil
First posted: 2018-05-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group using the "CAREGIVERSPRO-MMD" platform versus control group
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Burden of primary caregivers
timeFrame: 18 months
Secondary outcomes:
measure: Quality of life of patients
timeFrame: 6 months
measure: Quality of life of patients
timeFrame: 18 months
measure: Quality of life of patients
timeFrame: 12 months
measure: Quality of life of caregivers
timeFrame: 6 months
measure: Quality of life of caregivers
timeFrame: 12 months
measure: Cognitive symptoms of patients
timeFrame: 18 months
measure: Cognitive symptoms of patients
timeFrame: 6 months
measure: Cognitive symptoms of patients
timeFrame: 12 months
measure: Psychological symptoms of caregivers (1)
timeFrame: 6 months
measure: Psychological symptoms of caregivers (1)
timeFrame: 12 months
measure: Psychological symptoms of caregivers (1)
timeFrame: 18 months
measure: Psychological symptoms of caregivers (2)
timeFrame: 6 months
measure: Psychological symptoms of caregivers (2)
timeFrame: 12 months
measure: Psychological symptoms of caregivers (2)
timeFrame: 18 months
measure: Instrumental Activities of Daily Living
timeFrame: 6 months
measure: Instrumental Activities of Daily Living
timeFrame: 12 months
measure: Instrumental Activities of Daily Living
timeFrame: 18 months
measure: Activities of Daily Living
timeFrame: 12 months
measure: Activities of Daily Living
timeFrame: 18 months
measure: Activities of Daily Living
timeFrame: 6 months
measure: Behavioural-psychological symptoms of patients (1)
timeFrame: 6 months
measure: Behavioural-psychological symptoms of patients (1)
timeFrame: 12 months
measure: Behavioural-psychological symptoms of patients (1)
timeFrame: 18 months
measure: Behavioural-psychological symptoms of patients (2)
timeFrame: 18 months
measure: Behavioural-psychological symptoms of patients (2)
timeFrame: 6 months
measure: Behavioural-psychological symptoms of patients (2)
timeFrame: 12 months
measure: Perceived Social Support
timeFrame: 6 months
measure: Perceived Social Support
timeFrame: 12 months
measure: Perceived Social Support
timeFrame: 18 months
measure: Relationships
timeFrame: 6 months
measure: Relationships
timeFrame: 12 months
measure: Relationships
timeFrame: 18 months
Other outcomes:
Locations:
city: Elbeuf
country: France
facility: Centre Hospitalier Intercommunal Elbeuf Louviers
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Isabelle Landrin, MD
role: PRINCIPAL_INVESTIGATOR
References: