NCT03536975

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 25, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2019

Completed
Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

January 30, 2018

Last Update Submit

April 13, 2026

Conditions

Cognitive Impairment, MildDementia, Mild

Keywords

DementiaMild DementiaCognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (32)

  • Quality of life of patients

    6 months

  • Quality of life of patients

    18 months

  • Quality of life of patients

    12 months

  • Quality of life of caregivers

    6 months

  • Quality of life of caregivers

    12 months

  • +27 more secondary outcomes

Study Arms (2)

Platform

OTHER

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

Other: Platform

Control

NO INTERVENTION

Group without any access to the web platform

Interventions

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

Platform

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Intercommunal Elbeuf Louviers

Elbeuf, France

Location

Rouen University Hospital

Rouen, France

Location

Related Publications (1)

  • 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.

    PMID: 30684403RESULT

MeSH Terms

Conditions

Cognitive DysfunctionDementiaLymphoma, Follicular

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Isabelle Landrin, MD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Intervention group using the "CAREGIVERSPRO-MMD" platform versus control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2018

First Posted

May 25, 2018

Study Start

December 1, 2017

Primary Completion

April 29, 2019

Study Completion

April 29, 2019

Last Updated

April 17, 2026

Record last verified: 2026-04

Locations

FR(2)