Major Memory 2: A Long-term Group Cognitive Stimulation Program (NCT04178564) | Clinical Trial Compass
SuspendedNot Applicable
Major Memory 2: A Long-term Group Cognitive Stimulation Program
Stopped: Covid-19 pandemic
Portugal70 participantsStarted 2020-02-10
Plain-language summary
This study aims to evaluate the effect of a long-term group cognitive stimulation (CS) program on the cognitive function of institutionalized elderly people with neurocognitive disorders. The study also aims to assess the program's feasibility in institutions located in the Portuguese town of Oliveira do Bairro.
The investigators propose the realization of a quasi-experimental longitudinal study with a one-group pretest-posttest design. The subjects will participate in CS sessions as part of a group, once a week, for one year, while maintaining their usual care in the institution. The program will have 47 sessions, once per week, with 1 hour each. In each participating institution, one group will be formed. In groups composed by participants with mild neurocognitive disorder, the maximum number will be 10 participants per group, in groups composed by participants with major neurocognitive disorder, the maximum number will be 6 participants per group. In each institution, patients who meet the inclusion and exclusion criteria will be selected to become part of a cognitive stimulation group program.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Having a diagnosis of neurocognitive disorder according to the Diagnostic and Statistical Manual of Mental Disorder.
* Having a score between 2 and 5 according to the Global Deterioration Scale (obtained from the participant's score on Mini-Mental State Examination).
* Age over 60 years old.
* Attending one of the institutions participating in the study.
Exclusion Criteria:
* To have received psychological or psychiatric care in the last two months.
* Not being able to communicate and understand.
* To suffer from an acute or severe illness that makes their participation in the sessions impossible.
* Sensory and physical limitation that prevent their participation in the sessions.
* Limited attention span that prevents attending a one-hour group session.
* Presence of severe neuropsychiatric symptoms that prevent their participation in the sessions or uncontrolled delirium.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cognitive functioning evaluated through Mini-Mental State Examination
Timeframe: Time Frame: Pre, intra (6 months) and post intervention (12 months)
2
Cognitive functioning evaluated through Frontal Assessment Battery
Timeframe: Time Frame: Pre, intra (6 months) and post intervention (12 months)