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 (CAREGIVERSPRO)

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

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 Overview

• Status: Completed
• Conditions: Cognitive Impairment, Mild; Dementia, Mild
• Intervention / Treatment: Other: Platform

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Elbeuf, France
    • Centre Hospitalier Intercommunal Elbeuf Louviers
  • Rouen, France
    • Rouen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Platform; Group with access to the web platform "CAREGIVERSPRO-MMD"	Other: 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
No Intervention: Control; Group without any access to the web platform

What is the study measuring?

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) rated from 0 to 88, 0 is a weak charge and more than 40 is a severe charge.	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 (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
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
Psychological symptoms of caregivers (1)	Geriatric Depression Scale will be used to evaluate depression of older caregivers. Scale with 15 items rated from 0 to 15, 15 is the worse case with the highest degree of depression	6 months
Psychological symptoms of caregivers (1)	Geriatric Depression Scale will be used to evaluate depression of older caregivers. Scale with 15 items rated from 0 to 15, 15 is the worse case with the highest degree of depression	12 months
Psychological symptoms of caregivers (1)	Geriatric Depression Scale will be used to evaluate depression of older caregivers. Scale with 15 items rated from 0 to 15, 15 is the worse case with the highest degree of depression	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). Each item is rated from 0 for dependent and 1 independent. There are 8 items.	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). Each item is rated from 0 for dependent and 1 independent. There are 8 items.	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). Each item is rated from 0 for dependent and 1 independent. There are 8 items.	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). The scale is rated from 0 to 100. 0 is the most dependent stage and 100 is the most independent.	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). The scale is rated from 0 to 100. 0 is the most dependent stage and 100 is the most independent.	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). The scale is rated from 0 to 100. 0 is the most dependent stage and 100 is the most independent.	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Collaborators: Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil
• Investigators: Principal Investigator: Isabelle Landrin, MD, University Hospital, Rouen

Publications and helpful links

General Publications

• Zafeiridi P, Paulson K, Dunn R, Wolverson E, White C, Thorpe JA, Antomarini M, Cesaroni F, Scocchera F, Landrin-Dutot I, Malherbe L, Lingiah H, Berard M, Girones X, Quintana M, Cortes U, Barrue C, Cortes A, Paliokas I, Votis K, Tzovaras D. A Web-Based Platform for People With Memory Problems and Their Caregivers (CAREGIVERSPRO-MMD): Mixed-Methods Evaluation of Usability. JMIR Form Res. 2018 Mar 12;2(1):e4. doi: 10.2196/formative.9083.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): April 29, 2019
• Study Completion (Actual): April 29, 2019

Study Registration Dates

• First Submitted: January 30, 2018
• First Submitted That Met QC Criteria: May 14, 2018
• First Posted (Actual): May 25, 2018

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Cognitive Impairment; Dementia; Mild Dementia
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Neurocognitive Disorders; Cognition Disorders; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Hemic and Lymphatic Diseases; Cognitive Dysfunction; Lymphoma, Follicular; Dementia
• Other Study ID Numbers: 2016/369/HP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No