NCT05791006

Brief Summary

The present project aims to investigate the financial capacity in patients diagnosed with Parkinson's Disease or parkinsonism, brain tumor (glioma or meningioma) and cerebrovascular lesion (stroke), in order to evaluate the presence and degree of impairment, and the role of some factors as potential predictors of financial incapacity. The term 'financial capacity' means both operations relating, for example, to asset management or investing money, and activities of daily life such as shopping or using small sums of money; these activities are mediated by different cognitive functions, from numerical and arithmetic skills to decision making. Financial capacity is, in fact, an instrumental activity of daily life (i.e. Instrumental Activity Of Daily Living, I-ADL) whose impairment negatively affects the functional autonomy of the individual, so as to be subject to legal protection. To assess financial capacity, the Numerical Activities of Daily Living - Financial (NADL-F; Arcara et al., 2017) will be administered, a battery of tests aimed at investigating both financial performance and financial competence according to the most recent neuropsychological models proposed in the literature.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 4, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

3.3 years

First QC Date

March 5, 2023

Last Update Submit

March 16, 2023

Conditions

Outcome Measures

Primary Outcomes (6)

  • Numerical Activity of Daily Living Financial (NADL-F) in Patients with Parkinson's Disease/Parkinsonisms

    Assessment of financial capacity; score range=0-62; higher scores indicate higher financial capacities

    At baseline

  • Numerical Activity of Daily Living Financial (NADL-F) in Patients with ischemic or haemorrhagic stroke

    Assessment of financial capacity; score range=0-62; higher scores indicate higher financial capacities

    At baseline

  • Change from baseline in Numerical Activity of Daily Living - Financial (NADL-F)Patients with brain tumors

    Assessment of financial capacity; score range=0-62; higher scores indicate higher financial capacities

    At 3 and 12 months follow up

  • Montreal Cognitive Assessment (MoCA)

    Assessment of global cognitive functioning

    At baseline

  • Frontal Assessment Battery (FAB)

    Assessment of global cognitive functioning

    At baseline

  • Activities of daily living questionnaire (ADL)

    Assessment of function independence in everyday life

    At baseline

Study Arms (4)

Patients with Parkinson's Disease/Parkinsonisms

Behavioral: Neuropsychological tests

Patients with brain tumors

Behavioral: Neuropsychological tests

Patients with ischemic or haemorrhagic stroke

Behavioral: Neuropsychological tests

Healthy Controls

Behavioral: Neuropsychological tests

Interventions

Neuropsychological assessment with: * NADL-F * Frontal Assessment Battery (FAB) * functional scales assessing activities of daily living (ADL) and instrumental activities of daily living (I-ADL) * Mini-Mental Parkinson (MMP) - For Parkinson's Disease patients * Montreal Cognitive Assessment (MoCA) - for brain tumor and stroke patients

Healthy ControlsPatients with Parkinson's Disease/ParkinsonismsPatients with brain tumorsPatients with ischemic or haemorrhagic stroke

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Patients with Parkinson's Disease/parkinsonisms * Patients with brain tumor * Patients with stroke * Healthy controls

You may qualify if:

  • age \> 18 years
  • Clinical diagnosis of interest for clinical groups
  • For stroke patients: disease duration \> 1 month

You may not qualify if:

  • Other brain disorders different from those of interest
  • Sensory-motor deficits that could prevent neuropsychological assessment
  • Language disorders that could prevent neuropsychological assessment
  • Global cognitive impairment as indexed by MoCA \< 26 or MMP \< 22.85

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano IRCCS

Milan, Lombardy, 20122, Italy

RECRUITING

Related Publications (1)

  • Arcara G, Burgio F, Benavides-Varela S, Toffano R, Gindri P, Tonini E, Meneghello F, Semenza C. Numerical Activities of Daily Living - Financial (NADL-F): A tool for the assessment of financial capacities double dagger. Neuropsychol Rehabil. 2019 Aug;29(7):1062-1084. doi: 10.1080/09602011.2017.1359188. Epub 2017 Sep 7.

    PMID: 28880732BACKGROUND

MeSH Terms

Conditions

Parkinson DiseaseBrain NeoplasmsStroke

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsCerebrovascular DisordersVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Central Study Contacts

Nadia Bolognini, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2023

First Posted

March 30, 2023

Study Start

August 4, 2021

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

March 30, 2023

Record last verified: 2023-03

Locations