Clinical Trials Directory

Trials / Completed

CompletedNCT04417751

Care at 360º: A Long-term Individual Cognitive Stimulation Program

Care at 360º: A Long-term Individual Cognitive Stimulation Program for Older Adults With Neurocognitive Disorders, Non-Institutionalized and Socially Vulnerable

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
59 (actual)
Sponsor
CEDIARA - Assoc. Solidariedade Social de Ribeira de Fráguas · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

Summary

The aim of the intervention proposed in the present study is to assess the effect of a cognitive stimulation (CS) intervention program in an individual and long-term format, for non-institutionalized elderly people with neurocognitive disorders and in a situation of social vulnerability. Specifically, to test the effectiveness of CS on the global cognitive state, on mood state, on quality of life and on functional state. The program will be composed by 50 sessions, including three of assessment sessions (pre, intra and post-intervention). Each session will have a duration of 45 minutes with a weekly frequency. Control group participants will maintain their treatment as usual.

Detailed description

According to World Health Organization, between 2000 and 2050, the proportion of the planet's inhabitants over 60 years of age will double, from 11% to 22%. Specifically, this age group will increase from 605 million to 2000 million worldwide by the middle of the century. As for Portugal, according to data from the National Statistics Institute, the resident population was composed by 21.5% of elderly people. This percentage was higher than the European Union average of 28 countries (EU28), which does not reach 20%, with Portugal being the fourth country with the highest percentage of elderly people. Aging implies an increased risk for the development of biological, socioeconomic and psychosocial vulnerabilities, derived from biological decline and from an increase in pathologies associated with aging itself. In view of the current Covid-19 pandemic, the risk of vulnerability is heightened. There are several chronic diseases that affect the elderly. Regarding mental disorders, the most frequent as age, are neurocognitive disorders. The diagnostic criteria for this pathology emphasize cognitive changes, and as such, it is clinically based on cognitive and memory decline. There is evidence that in the early stages of neurocognitive disorders, people are able to learn and improve their cognitive function through interventions, such as cognitive stimulation. There are three types of cognitive intervention: cognitive stimulation, cognitive rehabilitation and cognitive training. Cognitive rehabilitation is an individual approach to cognitive impairment and improves daily functioning. Cognitive training is designed for the patient to perform a set of tasks in order to improve or maintain cognitive function through guided practice. Cognitive stimulation is an intervention where the cognitive domains are not used isolated, but rather integrated. Cognitive stimulation can be structured in an individual or group format. Individual cognitive stimulation includes activities designed to stimulate cognition, conducted only with the therapist and the patient. In a Portuguese study, with participants in the same geographic area, who applied individual cognitive stimulation therapy to patients with mild neurocognitive disorder, over a year, a significant improvement was found in the intervention group in terms of cognitive performance and a reduction of depressive symptoms, with a moderate to large effect size, suggesting that cognitive stimulation therapy is effective in an individual format. According to this evidence, the National Institute for Health and Clinical Excellence recommended cognitive stimulation as a non-pharmacological therapy for people with mild to moderate neurocognitive disorder. In a systematic review about cognitive stimulation, studies showed a strong evidence that cognitive stimulation has a positive impact on cognitive performance, depression, activities of daily living and behavior in people with neurocognitive disorders. Considering the previous information, the aim of this project is to apply cognitive stimulation in an individual format to improve cognitive status and performance, quality of life and functionality, and reduce depressive symptoms in non-institutionalized elderly people in a vulnerable social context with a diagnosis of neurocognitive disorder.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCognitive StimulationThe intervention includes 50 sessions, over the course of one year, being that 3 of those sessions will be the pretest, intratest and posttest evaluations. The intervention sessions will last approximately 45 minutes and they will be developed according to the following structure: welcoming and greeting the participants (5 minutes); reality orientation therapy (10 minutes), cognitive stimulation \[CS\] activity (25 minutes); return to calm and closure of the session, and session evaluation (5 minutes). CS sessions will be conducted in an individual intervention format. The intervention sessions will include several activities based on different non-pharmacological therapies (e.g., reminiscence therapy, reality orientation therapy, cognitive training) whose effectiveness in older adults with neurocognitive disorders has been scientifically proven. All individual CS sessions will be conducted by one therapist (clinical psychologist) with more than five years of experience in CS.

Timeline

Start date
2020-07-01
Primary completion
2021-07-26
Completion
2021-07-26
First posted
2020-06-05
Last updated
2021-07-27

Locations

1 site across 1 country: Portugal

Source: ClinicalTrials.gov record NCT04417751. Inclusion in this directory is not an endorsement.