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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cognitive Impairment, Mild, Dementia, Mild

Intervention / Treatment
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* Other: Platform


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention group using the CAREGIVERSPRO-MMD platform versus control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Platform<br>Group with access to the web platform CAREGIVERSPRO-MMD | Other: Platform<br>* 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<br>|
| No Intervention: Control<br>Group without any access to the web platform | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Burden of primary caregivers | To evaluate the perceived burden of primary caregivers of persons living with mild cognitive impairment or mild to moderate dementia in order to identify a benefit from use of the CAREGIVERSPRO-MMD platform. The perceived burden will be evaluated by using a 29-item scale, Zarit Burden Interview (ZBI). | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life of patients | The 28-item DEMQoL (Dementia Quality of Life Proxy) assesses quality of life of people with mild to moderate dementia. It evaluates five domains: daily activities and locking after health and well-being, cognitive functioning, social relationships and self-concept. | 6 months | 
| Quality of life of patients | The 28-item DEMQoL (Dementia Quality of Life Proxy) assesses quality of life of people with mild to moderate dementia. It evaluates five domains: daily activities and locking after health and well-being, cognitive functioning, social relationships and self-concept. | 18 months | 
| Quality of life of patients | The 28-item DEMQoL (Dementia Quality of Life Proxy) assesses quality of life of people with mild to moderate dementia. It evaluates five domains: daily activities and locking after health and well-being, cognitive functioning, social relationships and self-concept. | 12 months | 
| Quality of life of caregivers | The SF-36v2 - Medical Outcomes Study (MOS) 36-Item Short Form 2nd version will be used for caregivers. | 6 months | 
| Quality of life of caregivers | The SF-36v2 - Medical Outcomes Study (MOS) 36-Item Short Form 2nd version will be used for caregivers. | 12 months | 
| Cognitive symptoms of patients | Mini-Mental State Examination will be used to evaluate cognitive symptoms of patients with mild to moderate dementia. | 18 months | 
| Cognitive symptoms of patients | Mini-Mental State Examination will be used to evaluate cognitive symptoms of patients with mild to moderate dementia. | 6 months | 
| Cognitive symptoms of patients | Mini-Mental State Examination will be used to evaluate cognitive symptoms of patients with mild to moderate dementia. | 12 months | 
| Psychological symptoms of caregivers (1) | Geriatric Depression Scale will be used to evaluate depression of older caregivers | 6 months | 
| Psychological symptoms of caregivers (1) | Geriatric Depression Scale will be used to evaluate depression of older caregivers | 12 months | 
| Psychological symptoms of caregivers (1) | Geriatric Depression Scale will be used to evaluate depression of older caregivers | 18 months | 
| Psychological symptoms of caregivers (2) | State Trait Anxiety Inventory will be used to measure trait and state anxiety of caregivers | 6 months | 
| Psychological symptoms of caregivers (2) | State Trait Anxiety Inventory will be used to measure trait and state anxiety of caregivers | 12 months | 
| Psychological symptoms of caregivers (2) | State Trait Anxiety Inventory will be used to measure trait and state anxiety of caregivers | 18 months | 
| Instrumental Activities of Daily Living | The ability to perform tasks necessary to live independently in the community will be assessed using Lawton Instrumental Activities of Daily Living Scale (IADL), (Lawton and Brody 1969) | 6 months | 
| Instrumental Activities of Daily Living | The ability to perform tasks necessary to live independently in the community will be assessed using Lawton Instrumental Activities of Daily Living Scale (IADL), (Lawton and Brody 1969) | 12 months | 
| Instrumental Activities of Daily Living | The ability to perform tasks necessary to live independently in the community will be assessed using Lawton Instrumental Activities of Daily Living Scale (IADL), (Lawton and Brody 1969) | 18 months | 
| Activities of Daily Living | Performance in activity of daily living will be measured using Barthel Index of Activities of Daily Living scale (BADL) (Mahoney and Barthel 1965). | 12 months | 
| Activities of Daily Living | Performance in activity of daily living will be measured using Barthel Index of Activities of Daily Living scale (BADL) (Mahoney and Barthel 1965). | 18 months | 
| Activities of Daily Living | Performance in activity of daily living will be measured using Barthel Index of Activities of Daily Living scale (BADL) (Mahoney and Barthel 1965). | 6 months | 
| Behavioural-psychological symptoms of patients (1) | Behavioural-psychological symptoms will be evaluated using NeuroPsychiatric Inventory (12-item NPI). The score takes into account the frequency and severity of each behavioural symptom. | 6 months | 
| Behavioural-psychological symptoms of patients (1) | Behavioural-psychological symptoms will be evaluated using NeuroPsychiatric Inventory (12-item NPI). The score takes into account the frequency and severity of each behavioural symptom. | 12 months | 
| Behavioural-psychological symptoms of patients (1) | Behavioural-psychological symptoms will be evaluated using NeuroPsychiatric Inventory (12-item NPI). The score takes into account the frequency and severity of each behavioural symptom. | 18 months | 
| Behavioural-psychological symptoms of patients (2) | Geriatric Depression Scale 15 items evaluate depression of older people. A score above 11 is in favour of depression state. | 18 months | 
| Behavioural-psychological symptoms of patients (2) | Geriatric Depression Scale 15 items evaluate depression of older people. A score above 11 is in favour of depression state. | 6 months | 
| Behavioural-psychological symptoms of patients (2) | Geriatric Depression Scale 15 items evaluate depression of older people. A score above 11 is in favour of depression state. | 12 months | 
| Perceived Social Support | Multidimensional Scale of Perceived Social Support (MSPSS) 12 items scale will be used to assess an individual's perception of the social support received from family, friends and significant others. Each item is quoted from 1(totally disagree) to 7 (totally agree). | 6 months | 
| Perceived Social Support | Multidimensional Scale of Perceived Social Support (MSPSS) 12 items scale will be used to assess an individual's perception of the social support received from family, friends and significant others. Each item is quoted from 1(totally disagree) to 7 (totally agree). | 12 months | 
| Perceived Social Support | Multidimensional Scale of Perceived Social Support (MSPSS) 12 items scale will be used to assess an individual's perception of the social support received from family, friends and significant others. Each item is quoted from 1(totally disagree) to 7 (totally agree). | 18 months | 
| Relationships | The Flourishing Scale will be used to measure of the respondent's self-perceived success in important areas such as relationships, self-esteem, purpose and optimism. The scale provides a single psychological well-being score. It is a 8-item scale quoted from 1(totally disagree) to 7 (totally agree). | 6 months | 
| Relationships | The Flourishing Scale will be used to measure of the respondent's self-perceived success in important areas such as relationships, self-esteem, purpose and optimism. The scale provides a single psychological well-being score. It is a 8-item scale quoted from 1(totally disagree) to 7 (totally agree). | 12 months | 
| Relationships | The Flourishing Scale will be used to measure of the respondent's self-perceived success in important areas such as relationships, self-esteem, purpose and optimism. The scale provides a single psychological well-being score. It is a 8-item scale quoted from 1(totally disagree) to 7 (totally agree). | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dementia, Mild Dementia, Cognitive Impairment