The Effects of Apathy on Different Forms of Fatigue (NCT04573712) | Clinical Trial Compass
CompletedNot Applicable
The Effects of Apathy on Different Forms of Fatigue
France57 participantsStarted 2021-01-14
Plain-language summary
60 participants with light neuro-cognitive disorders (30 apathetic, 30 non-apathetic) will be recruited from the CMRR (Centre Mémoire Ressources et Recherche) in Nice University Hospital and from the " Fragilily " Platform of the Nice University Hospital.
After verification by the investigator, if they meet the inclusion criteria and sign the informed consent, participants will have to wear an actigraph for one week in order to measure their level of activity.
Afterwards, participants will have to complete assessments and questionnaires to evaluate apathy (Apathy Motivation Index, Apathy Inventory), perceived fatigue (Fatigue Severity Scale, Borg scale), fatigability (6-min walking test, isometric strength test, double task), the stress level (Perceived Stress Scale) and depression (Geriatric Depression Scale).
Regarding the activity level, they will also be asked to perform tasks to evaluate their kinematic movements( through an actigraph), and their particular sensitivity towards effort and reward (through serious game 'Tap-piscine').
The total duration of the evaluation is a maximum of 2 hours.
Who can participate
Age range
65 Years – 85 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:
* Men or women aged between 65 and 85 years old coming for consultation at the RMC and the Fragility Platform
* DSM-5 diagnosis: minor neurocognitive disorders
* Subject must read and write in French.
* Subject must be registered in the national social security scheme.
* Ability to sign free and informed consent.
For the 'apathetic' group:
\- Presence of apathy/emotional symptoms: at least 2 criteria according to the diagnostic criteria for apathy and a score higher than 8.5 in the MBI affective dimension.
For the 'non-apathetic' group:
\- Absence of apathy/emotional symptoms: no criteria according to the diagnostic criteria for apathy and a score of less than 8.5 in the MBI affective dimension.
Exclusion Criteria:
* Motor or sensory disabilities likely to interfere with the tests.
* Presence of major psychiatric disorders (e.g., schizophrenia, major depressive episode, bipolar disorder)
* Patient under guardianship, curatorship or under legal protection
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
comparison of Fatigue Severity Scale scores between apathetic and non-apathetic subjects.