NCT03195829

Brief Summary

This non-pharmacological interventional feasibility study evaluate a computerized cognitive stimulation program in elderly with mild cognitive impairment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable

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, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 22, 2017

Completed
Last Updated

June 22, 2017

Status Verified

June 1, 2017

Enrollment Period

7 months

First QC Date

June 12, 2017

Last Update Submit

June 20, 2017

Conditions

Keywords

Mild Cognitive ImpairmentComputerized Cognitive StimulationCognitionPsychosocial factors

Outcome Measures

Primary Outcomes (1)

  • GROBER-BUSCHKE TEST

    Assessment of free and cued recall of episodic memory

    Baseline assessment before intervention, change from baseline at 3 months immediately after intervention

Secondary Outcomes (1)

  • Technologies Acceptation Questionnaire

    Baseline assessment before intervention, change from baseline at 3 months immediately after intervention

Study Arms (2)

Computerized cognitive stimulation

EXPERIMENTAL

Computerized Cognitive Stimulation was administered to intervention group (IG).

Behavioral: Computerized Cognitive Stimulation

Multimedia-based internet activities

ACTIVE COMPARATOR

Multimedia-based internet activities was administered to active control group (ACG).

Behavioral: Multimedia-based internet

Interventions

The intervention group performed 12-week, 90-minutes per week of cognitive stimulation in group using a tablet with a commercial software with specific exercises to train the cognitive functioning and promote the relation ties in group-session.The program's difficulty level was adjusted to the MMSE score, and was gradually increased.

Computerized cognitive stimulation

The active control group had access to different Multimedia contents (travel, photos, music, TV program, cooking recipes) using a tablet, 90-minutes per week each week during 3-months. Each group session was centered in a particular topic, participants were able to select different media free available in Internet.

Multimedia-based internet activities

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Mild Cognitive Impairment
  • Absence of history of alcohol or other substance consumption
  • No engagement in other cognitive intervention program

You may not qualify if:

  • Psychiatric and neurological disorders
  • Conversion toward dementia during intervention
  • Sensory and or motor deficit that could interfere with the use of computer tool

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Anne-Sophie AR RIGAUD, Professor

    Broca University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled pilot study, single blind
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Neuropsychologist

Study Record Dates

First Submitted

June 12, 2017

First Posted

June 22, 2017

Study Start

December 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

June 22, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share