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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 48
- Locations
- 2
- Primary Endpoint
- Burden of primary caregivers
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Control
Group without any access to the web platform
Platform
Group with access to the web platform "CAREGIVERSPRO-MMD"
Intervention: Platform (Other)
Outcomes
Primary Outcomes
Burden of primary caregivers
Time Frame: 18 months
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) rated from 0 to 88, 0 is a weak charge and more than 40 is a severe charge.
Secondary Outcomes
- Psychological symptoms of caregivers (2)(18 months)
- Psychological symptoms of caregivers (1)(18 months)
- Instrumental Activities of Daily Living(18 months)
- Activities of Daily Living(6 months)
- Quality of life of patients(6 months)
- Quality of life of patients(18 months)
- Quality of life of caregivers(6 months)
- Cognitive symptoms of patients(18 months)
- Cognitive symptoms of patients(6 months)
- Psychological symptoms of caregivers (1)(6 months)
- Psychological symptoms of caregivers (1)(12 months)
- Psychological symptoms of caregivers (2)(6 months)
- Psychological symptoms of caregivers (2)(12 months)
- Instrumental Activities of Daily Living(6 months)
- Instrumental Activities of Daily Living(12 months)
- Activities of Daily Living(12 months)
- Activities of Daily Living(18 months)
- Behavioural-psychological symptoms of patients (1)(6 months)
- Behavioural-psychological symptoms of patients (1)(12 months)
- Behavioural-psychological symptoms of patients (2)(18 months)
- Behavioural-psychological symptoms of patients (2)(6 months)
- Perceived Social Support(6 months)
- Perceived Social Support(12 months)
- Relationships(6 months)
- Relationships(12 months)
- Quality of life of patients(12 months)
- Cognitive symptoms of patients(12 months)
- Quality of life of caregivers(12 months)
- Behavioural-psychological symptoms of patients (1)(18 months)
- Perceived Social Support(18 months)
- Relationships(18 months)
- Behavioural-psychological symptoms of patients (2)(12 months)