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Completed

NCT Number: NCT03536975

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

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.

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Key information

Conditions

Cognitive Impairment, Mild Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Dementia, Mild Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mental Disorders Neoplasms Neoplasms by Histologic Type Nervous System Diseases Neurocognitive Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Intercommunal Elbeuf Louviers, Elbeuf, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platform

Other

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 outcomes

  1. 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

  1. Quality of life of patients

    Time frame: 6 months

    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.

  2. Quality of life of patients

    Time frame: 18 months

    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.

  3. Quality of life of patients

    Time frame: 12 months

    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.

  4. Quality of life of caregivers

    Time frame: 6 months

    The SF-36v2 - Medical Outcomes Study (MOS) 36-Item Short Form 2nd version will be used for caregivers.

  5. Quality of life of caregivers

    Time frame: 12 months

    The SF-36v2 - Medical Outcomes Study (MOS) 36-Item Short Form 2nd version will be used for caregivers.

  6. Cognitive symptoms of patients

    Time frame: 18 months

    Mini-Mental State Examination will be used to evaluate cognitive symptoms of patients with mild to moderate dementia.

  7. Cognitive symptoms of patients

    Time frame: 6 months

    Mini-Mental State Examination will be used to evaluate cognitive symptoms of patients with mild to moderate dementia.

  8. Cognitive symptoms of patients

    Time frame: 12 months

    Mini-Mental State Examination will be used to evaluate cognitive symptoms of patients with mild to moderate dementia.

  9. Psychological symptoms of caregivers (1)

    Time frame: 6 months

    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

  10. Psychological symptoms of caregivers (1)

    Time frame: 12 months

    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

  11. Psychological symptoms of caregivers (1)

    Time frame: 18 months

    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. Psychological symptoms of caregivers (2)

    Time frame: 6 months

    State Trait Anxiety Inventory will be used to measure trait and state anxiety of caregivers

  13. Psychological symptoms of caregivers (2)

    Time frame: 12 months

    State Trait Anxiety Inventory will be used to measure trait and state anxiety of caregivers

  14. Psychological symptoms of caregivers (2)

    Time frame: 18 months

    State Trait Anxiety Inventory will be used to measure trait and state anxiety of caregivers

  15. Instrumental Activities of Daily Living

    Time frame: 6 months

    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.

  16. Instrumental Activities of Daily Living

    Time frame: 12 months

    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.

  17. Instrumental Activities of Daily Living

    Time frame: 18 months

    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. Activities of Daily Living

    Time frame: 12 months

    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.

  19. Activities of Daily Living

    Time frame: 18 months

    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.

  20. Activities of Daily Living

    Time frame: 6 months

    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.

  21. Behavioural-psychological symptoms of patients (1)

    Time frame: 6 months

    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.

  22. Behavioural-psychological symptoms of patients (1)

    Time frame: 12 months

    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.

  23. Behavioural-psychological symptoms of patients (1)

    Time frame: 18 months

    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.

  24. Behavioural-psychological symptoms of patients (2)

    Time frame: 18 months

    Geriatric Depression Scale 15 items evaluate depression of older people. A score above 11 is in favour of depression state.

  25. Behavioural-psychological symptoms of patients (2)

    Time frame: 6 months

    Geriatric Depression Scale 15 items evaluate depression of older people. A score above 11 is in favour of depression state.

  26. Behavioural-psychological symptoms of patients (2)

    Time frame: 12 months

    Geriatric Depression Scale 15 items evaluate depression of older people. A score above 11 is in favour of depression state.

  27. Perceived Social Support

    Time frame: 6 months

    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).

  28. Perceived Social Support

    Time frame: 12 months

    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).

  29. Perceived Social Support

    Time frame: 18 months

    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).

  30. Relationships

    Time frame: 6 months

    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).

  31. Relationships

    Time frame: 12 months

    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).

  32. Relationships

    Time frame: 18 months

    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).

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Collaborators

  • Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil

Registry information

Official study 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

Acronym: CAREGIVERSPRO

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 25, 2018
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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