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The Effects of Apathy on Different Forms of Fatigue (FAME1)

Primary Purpose

Apathy, Fatigue

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Follow up and Assessment
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Apathy

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Memoire Ressources et Recherche, CHU de Nice

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fatigue Severity Scale scores assessment

Arm Description

Fatigue Severity Scale scores assessment

Outcomes

Primary Outcome Measures

comparison of Fatigue Severity Scale scores between apathetic and non-apathetic subjects.
the minimum score is 9 (worse outcome) and the maximum score is 63 (better outcome)

Secondary Outcome Measures

Full Information

First Posted
September 28, 2020
Last Updated
October 2, 2020
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT04573712
Brief Title
The Effects of Apathy on Different Forms of Fatigue
Acronym
FAME1
Official Title
FAME 1: The Effects of Apathy on Different Forms of Fatigue
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apathy, Fatigue

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fatigue Severity Scale scores assessment
Arm Type
Experimental
Arm Description
Fatigue Severity Scale scores assessment
Intervention Type
Other
Intervention Name(s)
Follow up and Assessment
Intervention Description
each patient should wear an actigraph during a week and will be do some tests during 2hours (6min walk, apathy inventory, fatigue severity scale etc...)
Primary Outcome Measure Information:
Title
comparison of Fatigue Severity Scale scores between apathetic and non-apathetic subjects.
Description
the minimum score is 9 (worse outcome) and the maximum score is 63 (better outcome)
Time Frame
at inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
philippe ROBERT, PU-PH
Phone
0492034770
Email
philippe.robert@univ-cotedazur.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Valéria MANERA, PhD
Phone
0492034770
Email
Valeria.Manera@unice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe ROBERT, PU-PH
Organizational Affiliation
CHU de NICE, Centre Mémoire Ressources et Recherches
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Memoire Ressources et Recherche, CHU de Nice
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valeria MANERA, PhD
Email
Valeria.Manera@unice.fr
First Name & Middle Initial & Last Name & Degree
Philippe ROBERT, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35608793
Citation
Daumas L, Zory R, Robert P, Manera V. Apathetic patients with neurocognitive disorders are more fatigued and fatigable. Aging Clin Exp Res. 2022 Sep;34(9):2237-2241. doi: 10.1007/s40520-022-02146-4. Epub 2022 May 24.
Results Reference
derived

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The Effects of Apathy on Different Forms of Fatigue

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