Feasibility Study of a Computerized Cognitive Stimulation (PSCogStim)

June 20, 2017 updated by: Leila DJABELKHIR

A Computerized Cognitive Stimulation Program in Elderly With Mild Cognitive Impairment: A Feasibility Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Involvement in social and leisure activities has been associated with a decreased risk of dementia in the elderly with Mild Cognitive Impairment (MCI). MCI is a crucial phase to prevent the worsening of cognitive decline in elderly at risk to develop dementia. These last years, the use of computerized training programs to enhance cognitive functioning showed positive and promising results. However, the effects on psychosocial factors still poorly documented in cognitive interventions in MCI. It seems essential to promote these factors involving social ties, group dynamic, the motivation, as factors that can contribute to enhance social life and cognitive functioning.

This feasibility study evaluated a computer-based cognitive stimulation in elderly with MCI and explore the effects on cognitive and psychosocial components.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Computerized cognitive stimulation
Computerized Cognitive Stimulation was administered to intervention group (IG).
Behavioral: Computerized Cognitive Stimulation
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.
Active Comparator: Multimedia-based internet activities
Multimedia-based internet activities was administered to active control group (ACG).
Behavioral: Multimedia-based internet
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GROBER-BUSCHKE TEST
Time Frame: Baseline assessment before intervention, change from baseline at 3 months immediately after intervention
Assessment of free and cued recall of episodic memory
Baseline assessment before intervention, change from baseline at 3 months immediately after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technologies Acceptation Questionnaire
Time Frame: Baseline assessment before intervention, change from baseline at 3 months immediately after intervention
Assessment of acceptability of communication and information technologies
Baseline assessment before intervention, change from baseline at 3 months immediately after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leila DJABELKHIR

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

June 12, 2017

First Submitted That Met QC Criteria

June 20, 2017

First Posted (Actual)

June 22, 2017

Study Record Updates

Last Update Posted (Actual)

June 22, 2017

Last Update Submitted That Met QC Criteria

June 20, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUSAGE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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