Cognitive Impairment, MildCAREGIVERSPRONCT03536975
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
A study testing Platform in people with Cognitive Impairment, Mild and Dementia, Mild, run by University Hospital, Rouen at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Mild, Dementia, Mild
- What is being tested?
- Platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Dec 2017to 29 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Intercommunal Elbeuf Louviers
Elbeuf
Rouen University Hospital
Rouen
About this study
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
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.
- Conditions
- Cognitive Impairment, Mild, Dementia, Mild
- Being tested
- Platform
- Keywords
- Dementia, Mild Dementia, Cognitive Impairment
- Medical subject headings
- Cognitive Dysfunction, Dementia, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlatformOther
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
| Study group | Role | What they receive |
|---|---|---|
| Platform | Other | Group with access to the web platform "CAREGIVERSPRO-MMD" Receives: Other: Platform |
| Control | No intervention | Group without any access to the web platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (32)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Cognitive symptoms of patients
Mini-Mental State Examination will be used to evaluate cognitive symptoms of patients with mild to moderate dementia.
Measured: 18 months
Cognitive symptoms of patients
Mini-Mental State Examination will be used to evaluate cognitive symptoms of patients with mild to moderate dementia.
Measured: 6 months
Cognitive symptoms of patients
Mini-Mental State Examination will be used to evaluate cognitive symptoms of patients with mild to moderate dementia.
Measured: 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
Measured: 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
Measured: 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
Measured: 18 months
Psychological symptoms of caregivers (2)
State Trait Anxiety Inventory will be used to measure trait and state anxiety of caregivers
Measured: 6 months
Psychological symptoms of caregivers (2)
State Trait Anxiety Inventory will be used to measure trait and state anxiety of caregivers
Measured: 12 months
Psychological symptoms of caregivers (2)
State Trait Anxiety Inventory will be used to measure trait and state anxiety of caregivers
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start1 Dec 2017
- Primary completion29 Apr 2019
- Study completion29 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive Impairment, MildStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group using the "CAREGIVERSPRO-MMD" platform versus control group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil
- Responsible party
- Sponsor
- Investigators
- Isabelle Landrin, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536975
- Sponsor's protocol ID
- 2016/369/HP
- Acronym
- CAREGIVERSPRO
- Status last verified
- Apr 2026
- First submitted
- 30 Jan 2018
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 30684403
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03536975
- Acronym / sponsor ID
- CAREGIVERSPRO / 2016/369/HP
- Conditions
- Cognitive Impairment, Mild, Dementia, Mild
- Keywords
- Dementia, Mild Dementia, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Collaborators
- Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 29 Apr 2019 (actual)
- Study completion
- 29 Apr 2019 (actual)
- First posted
- 25 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention group using the "CAREGIVERSPRO-MMD" platform versus control group
| Arm | Type | Receives |
|---|---|---|
| Platform | Other | Other: PlatformGroup with access to the web platform "CAREGIVERSPRO-MMD" |
| Control | No intervention | –Group without any access to the web platform |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlatformThe 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 | Other | Platform |
Primary outcome
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.
32 secondary outcomes
Quality of life of patients
Time frame: 6 months
Quality of life of patients
Time frame: 18 months
Quality of life of patients
Time frame: 12 months
Quality of life of caregivers
Time frame: 6 months
Quality of life of caregivers
Time frame: 12 months
Cognitive symptoms of patients
Time frame: 18 months
Cognitive symptoms of patients
Time frame: 6 months
Cognitive symptoms of patients
Time frame: 12 months
Psychological symptoms of caregivers (1)
Time frame: 6 months
Psychological symptoms of caregivers (1)
Time frame: 12 months
Psychological symptoms of caregivers (1)
Time frame: 18 months
Psychological symptoms of caregivers (2)
Time frame: 6 months
Psychological symptoms of caregivers (2)
Time frame: 12 months
Psychological symptoms of caregivers (2)
Time frame: 18 months
Instrumental Activities of Daily Living
Time frame: 6 months
Instrumental Activities of Daily Living
Time frame: 12 months
Instrumental Activities of Daily Living
Time frame: 18 months
Activities of Daily Living
Time frame: 12 months
Activities of Daily Living
Time frame: 18 months
Activities of Daily Living
Time frame: 6 months
Behavioural-psychological symptoms of patients (1)
Time frame: 6 months
Behavioural-psychological symptoms of patients (1)
Time frame: 12 months
Behavioural-psychological symptoms of patients (1)
Time frame: 18 months
Behavioural-psychological symptoms of patients (2)
Time frame: 18 months
Behavioural-psychological symptoms of patients (2)
Time frame: 6 months
Behavioural-psychological symptoms of patients (2)
Time frame: 12 months
Perceived Social Support
Time frame: 6 months
Perceived Social Support
Time frame: 12 months
Perceived Social Support
Time frame: 18 months
Relationships
Time frame: 6 months
Relationships
Time frame: 12 months
Relationships
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Results publication: PubMed 30684403Zafeiridi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Landrin, MD principal investigator
University Hospital, Rouen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platform in people with Cognitive Impairment, Mild and Dementia, Mild, run by University Hospital, Rouen at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Burden of primary caregivers (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03536975, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.