Feasibility Study of a Computerized Cognitive Stimulation

Study Overview
=================
Brief Summary
-----------------
This non-pharmacological interventional feasibility study evaluate a computerized cognitive stimulation program in elderly with mild cognitive impairment.

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.

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

Conditions
-----------------
Mild Cognitive Impairment, So Stated

Intervention / Treatment
-----------------
* Behavioral: Computerized Cognitive Stimulation
* Behavioral: Multimedia-based internet


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled pilot study, single blind
Masking: Double


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mild Cognitive Impairment, Computerized Cognitive Stimulation, Cognition, Psychosocial factors