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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)

Primary Purpose

Cognitive Impairment, Mild, Dementia, Mild

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Platform
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cognitive Impairment, Mild focused on measuring Dementia, Mild Dementia, Cognitive Impairment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centre Hospitalier Intercommunal Elbeuf LouviersRecruiting
  • Rouen University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Platform

Control

Arm Description

Group with access to the web platform "CAREGIVERSPRO-MMD"

Group without any access to the web platform

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.
Quality of life of caregivers
The SF-36v2 - Medical Outcomes Study (MOS) 36-Item Short Form 2nd version will be used for caregivers.
Quality of life of caregivers
The SF-36v2 - Medical Outcomes Study (MOS) 36-Item Short Form 2nd version will be used for caregivers.
Cognitive symptoms of patients
Mini-Mental State Examination will be used to evaluate cognitive symptoms of patients with mild to moderate dementia.
Cognitive symptoms of patients
Mini-Mental State Examination will be used to evaluate cognitive symptoms of patients with mild to moderate dementia.
Cognitive symptoms of patients
Mini-Mental State Examination will be used to evaluate cognitive symptoms of patients with mild to moderate dementia.
Psychological symptoms of caregivers (1)
Geriatric Depression Scale will be used to evaluate depression of older caregivers
Psychological symptoms of caregivers (1)
Geriatric Depression Scale will be used to evaluate depression of older caregivers
Psychological symptoms of caregivers (1)
Geriatric Depression Scale will be used to evaluate depression of older caregivers
Psychological symptoms of caregivers (2)
State Trait Anxiety Inventory will be used to measure trait and state anxiety of caregivers
Psychological symptoms of caregivers (2)
State Trait Anxiety Inventory will be used to measure trait and state anxiety of caregivers
Psychological symptoms of caregivers (2)
State Trait Anxiety Inventory will be used to measure trait and state anxiety of caregivers
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)
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)
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)
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).
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).
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).
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.
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.
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.
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.
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.
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.
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).
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).
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).
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).
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).
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).

Full Information

First Posted
January 30, 2018
Last Updated
May 14, 2018
Sponsor
University Hospital, Rouen
Collaborators
Centre Hospitalier Intercommunal Elbeuf-Louviers / Val de Reuil
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1. Study Identification

Unique Protocol Identification Number
NCT03536975
Brief Title
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
Acronym
CAREGIVERSPRO
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

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
Collaborators
Centre Hospitalier Intercommunal Elbeuf-Louviers / Val de Reuil

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment, Mild, Dementia, Mild
Keywords
Dementia, Mild Dementia, Cognitive Impairment

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention group using the "CAREGIVERSPRO-MMD" platform versus control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Platform
Arm Type
Other
Arm Description
Group with access to the web platform "CAREGIVERSPRO-MMD"
Arm Title
Control
Arm Type
No Intervention
Arm Description
Group without any access to the web platform
Intervention Type
Other
Intervention Name(s)
Platform
Intervention Description
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
Primary Outcome Measure Information:
Title
Burden of primary caregivers
Description
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).
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Quality of life of patients
Description
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.
Time Frame
6 months
Title
Quality of life of patients
Description
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.
Time Frame
18 months
Title
Quality of life of patients
Description
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.
Time Frame
12 months
Title
Quality of life of caregivers
Description
The SF-36v2 - Medical Outcomes Study (MOS) 36-Item Short Form 2nd version will be used for caregivers.
Time Frame
6 months
Title
Quality of life of caregivers
Description
The SF-36v2 - Medical Outcomes Study (MOS) 36-Item Short Form 2nd version will be used for caregivers.
Time Frame
12 months
Title
Cognitive symptoms of patients
Description
Mini-Mental State Examination will be used to evaluate cognitive symptoms of patients with mild to moderate dementia.
Time Frame
18 months
Title
Cognitive symptoms of patients
Description
Mini-Mental State Examination will be used to evaluate cognitive symptoms of patients with mild to moderate dementia.
Time Frame
6 months
Title
Cognitive symptoms of patients
Description
Mini-Mental State Examination will be used to evaluate cognitive symptoms of patients with mild to moderate dementia.
Time Frame
12 months
Title
Psychological symptoms of caregivers (1)
Description
Geriatric Depression Scale will be used to evaluate depression of older caregivers
Time Frame
6 months
Title
Psychological symptoms of caregivers (1)
Description
Geriatric Depression Scale will be used to evaluate depression of older caregivers
Time Frame
12 months
Title
Psychological symptoms of caregivers (1)
Description
Geriatric Depression Scale will be used to evaluate depression of older caregivers
Time Frame
18 months
Title
Psychological symptoms of caregivers (2)
Description
State Trait Anxiety Inventory will be used to measure trait and state anxiety of caregivers
Time Frame
6 months
Title
Psychological symptoms of caregivers (2)
Description
State Trait Anxiety Inventory will be used to measure trait and state anxiety of caregivers
Time Frame
12 months
Title
Psychological symptoms of caregivers (2)
Description
State Trait Anxiety Inventory will be used to measure trait and state anxiety of caregivers
Time Frame
18 months
Title
Instrumental Activities of Daily Living
Description
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)
Time Frame
6 months
Title
Instrumental Activities of Daily Living
Description
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)
Time Frame
12 months
Title
Instrumental Activities of Daily Living
Description
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)
Time Frame
18 months
Title
Activities of Daily Living
Description
Performance in activity of daily living will be measured using Barthel Index of Activities of Daily Living scale (BADL) (Mahoney and Barthel 1965).
Time Frame
12 months
Title
Activities of Daily Living
Description
Performance in activity of daily living will be measured using Barthel Index of Activities of Daily Living scale (BADL) (Mahoney and Barthel 1965).
Time Frame
18 months
Title
Activities of Daily Living
Description
Performance in activity of daily living will be measured using Barthel Index of Activities of Daily Living scale (BADL) (Mahoney and Barthel 1965).
Time Frame
6 months
Title
Behavioural-psychological symptoms of patients (1)
Description
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.
Time Frame
6 months
Title
Behavioural-psychological symptoms of patients (1)
Description
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.
Time Frame
12 months
Title
Behavioural-psychological symptoms of patients (1)
Description
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.
Time Frame
18 months
Title
Behavioural-psychological symptoms of patients (2)
Description
Geriatric Depression Scale 15 items evaluate depression of older people. A score above 11 is in favour of depression state.
Time Frame
18 months
Title
Behavioural-psychological symptoms of patients (2)
Description
Geriatric Depression Scale 15 items evaluate depression of older people. A score above 11 is in favour of depression state.
Time Frame
6 months
Title
Behavioural-psychological symptoms of patients (2)
Description
Geriatric Depression Scale 15 items evaluate depression of older people. A score above 11 is in favour of depression state.
Time Frame
12 months
Title
Perceived Social Support
Description
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).
Time Frame
6 months
Title
Perceived Social Support
Description
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).
Time Frame
12 months
Title
Perceived Social Support
Description
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).
Time Frame
18 months
Title
Relationships
Description
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).
Time Frame
6 months
Title
Relationships
Description
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).
Time Frame
12 months
Title
Relationships
Description
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).
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle Landrin
Phone
33 2 32 88 6523
Email
isabelle.landrin@chu-rouen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle Landrin, MD
Organizational Affiliation
University Hospital, Rouen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Intercommunal Elbeuf Louviers
City
Elbeuf
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thibault Simon, MD
First Name & Middle Initial & Last Name & Degree
Thibault Simon, MD
Facility Name
Rouen University Hospital
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Landrin, MD
First Name & Middle Initial & Last Name & Degree
Isabelle Landrin, MD

12. IPD Sharing Statement

Learn more about this trial

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

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