Viewing Study NCT05966207



Ignite Creation Date: 2024-05-06 @ 7:18 PM
Last Modification Date: 2024-10-26 @ 3:04 PM
Study NCT ID: NCT05966207
Status: COMPLETED
Last Update Posted: 2023-07-28
First Post: 2023-07-21

Brief Title: Individual Intervention of Cognitive Stimulation
Sponsor: Escola Superior de Enfermagem de Coimbra
Organization: Escola Superior de Enfermagem de Coimbra

Study Overview

Official Title: Making a Difference 3 - Individual Intervention of Cognitive Stimulation
Status: COMPLETED
Status Verified Date: 2023-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Population aging in Portugal has led to problematic social issues American Psychiatric Association 2013 Spector Woods Orrell 2008 Wimo Prince 2010 At the same time there is a noticeable increase in the prevalence of Neurocognitive Disorders NCDs commonly referred to in clinical practice as mild cognitive impairment and dementia Apóstolo Cardoso Silva Costa 2014 Apóstolo Cardoso 2014

NCDs can be classified based on the degree of cognitive decline ranging from mild to major and based on etiology which includes Alzheimers disease Vascular dementia Lewy body dementia Frontotemporal dementia and others American Psychiatric Association 2013

In the European context Portugal is among the minority of countries that do not have an official strategy for the care of people with mild cognitive impairment and dementia Therefore it is imperative to define national health policies that address the identified needs Knapp et al 2006

Currently non-pharmacological interventions such as Individual Cognitive Stimulation ICS are gaining relevance as treatment responses to the aforementioned syndromes due to the increasing clinical social and economic impact of mild cognitive impairment and dementia Aguirre Hoare Spector Woods Orrell 2014 Apóstolo et al 2014

ICS can be considered the implementation of a set of meaningful activities carried out over several sessions usually in a social context with the aim of stimulating various domains including attention thinking language memory and calculation Aguirre et al 2012 Apóstolo et al 2014 Yates Orrell Spector Orgeta 2015

Current evidence supports the effectiveness of this intervention indicating that ICS programs are associated with health benefits particularly in cognition mood well-being functional activity quality of life and communication skills Apóstolo et al 2014 Yates et al 2014

Providing care to people with mild cognitive impairment and dementia poses a challenge for the healthcare system necessitating the implementation of specific interventions to increase self-care potential autonomy adaptation and coping with deficits as well as empowering the family andor support network Alzheimer Europe 2013 Orrell et al 2012 Woods Aguirre Spector Orrell 2012 Yates et al 2015 Due to the global pandemic context of SARS-CoV-2 social care institutions for the elderly underwent changes in their dynamics One of the measures implemented during the emergency plan was the closure of adult day care centers The elderly who previously attended these social care facilities are now staying in their own homes or with familyinformal caregivers thus being deprived of the social and cognitive stimuli they were accustomed to

The mobilization of this population to their homes has led to increased social isolation and loneliness which are underestimated public health risks These factors affect a significant proportion of the elderly population and can lead to cognitive decline feelings of loneliness sadness and abandonment which were previously alleviated by the social care centers National Academies of Sciences Engineering and Medicine 2020

Given the described situation the Making a Difference 3 program - an ICS program - represents an excellent implementation option as it can be developed in various contexts including the home environment using cost-effective resources addressing many of the needs of both individuals with cognitive impairment and their informal family caregivers

In summary in Portugal there is no established practice of implementing structured ICS interventions with individual sessions for use in the home environment Thus there is a need for the MD3 program to be disseminated to promote best practices In response to the needs arising from the current pandemic context the team of this project aims to produce national evidence on the effect of ICS in individuals with mild cognitive impairment and dementia in the home environment of the elderly person managed by informal caregivers and supervised by healthcare professionals
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None