Neurocognitive Disorders
Conditions
Interventions
This is a non-randomized, unblinded, waitlist-controlled clinical trial with two arms. Participants will begin in the Control group (Waitlist): 60 participants will initially receive no intervention.
Quality of Life: Quality of Life in Alzheimer’s Disease (QoL-AD)
Depression: Cornell Scale for Depression in Dementia
Caregiver Burden: Zarit Caregiver Burden Scale (completed by caregivers)
F04.754.137.365
Sponsors
Faculdade de Medicina da Universidade Federal de Minas Gerais
Faculdade de Medicina da Universidade Federal de Minas Gerais
Eligibility
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: Older adults living in Long Term Care Facilities for the aged; with mild dementia; or with mild neurocognitive disorder; aged at least 60 years; both sexes
Exclusion criteria
Exclusion criteria: Communication disabilities; moderate to severe dementia; other severe decompensated mental disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to validate the Cognitive Stimulation Therapy protocol for Brazilian older adults residents of Long-Term Care Institutions for the Aged. Validation will be assessed by recruitment feasibility, retention rate, acceptability and fidelity of the intervention;It is expected to assess the feasibility of recruitment through the recruitment rate. This will be obtained by the ratio between the total number of participants who started the interventions and the total number of individuals screened. It is expected to achieve a recruitment rate of around 70%-80% ;It is expected to evaluate the retention rate, which consists of the ratio between the total number of participants who completed all Cognitive Stimulation Therapy sessions. The attendance rate calculated as the ratio between the number of sessions held and the number of sessions offered will also be evaluated. Expected to achieve a retention and attendance rate of 75%-85%;It is expected to evaluate the rate and acceptability of Cognitive Stimulation Therapy assessed by the description of negative or adverse events by the older adults that are related to the intervention;It is expected to evaluate the fidelity rate of the intervention according to the protocol. It will be assessed if, for any reason, it was not possible to carry out any step of the protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to evaluate the impact on the cognition of elderly people measured by the Mini Mental State Examination and Cambridge Cognitive Examination scales. It is expected that cognition may present less statistically significant decline or stability compared to the waiting list group;It is expected to evaluate the impact on emotional regulation and behavior of the older adults measured by the Cornell Scale for Depression in Dementia. It is expected that mood may show a statistically significant improvement in relation to the waiting list group. It is expected that participants with a score >10 probable depressive episode and >18 defined major depressive episode may present a change in clinical status;It is expected to evaluate improvements in quality of life measured by the Quality of Life in Alzheimer’s Disease. It is expected that the quality of life may present a statistically significant improvement in relation to the waiting list group;It is expected to evaluate improvement in caregiver burden measured by the caregiver burden scale for long-term care institutions for the elderly. It is expected that caregiver burden may present a statistically significant reduction in relation to the waiting list group | — |
Countries
Brazil
Contacts
Public ContactBernardo Viana
Faculdade de Medicina da Universidade Federal de Minas Gerais
Outcome results
None listed