Study of Comprehension and Execution of Medication Prescriptions in Parkinsonian Patients and Healthy Volunteers
NCT ID: NCT03976505
Last Updated: 2023-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
57 participants
INTERVENTIONAL
2018-06-15
2021-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This exploratory study aims at identifying the best format for presenting medication prescription to Pd patients. An experiment with Pd patients and healthy volunteers is carried out to analyze their behavior while filling a virtual pillbox from a education prescription presented electronically in different formats on a tablet or a touchscreen. A table format and a verbal format are compared to determine the most effective design for presenting medication schedules. A facilitating effect of the table format is hypothesized.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Rehabilitation of Everyday Memory Impairment in Parkinson Disease: A Pilot Study
NCT01469741
Pilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy Volunteers
NCT02785978
Effect of Donepezil on Cognition in Parkinson's Disease With Mild Cognitive Impairment (PD-MCI)
NCT02450786
European Compliance Study in Parkinson's Disease
NCT00466739
Patient Engagement Investigation of NMS Assist
NCT07038486
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
One-hundred and twenty patients with Parkinson's disease and 120 healthy volunteers participate voluntarily to the study. Their task consists in reading on a touch screen, or on a tablet, two fictive medication prescriptions. One is presented in a table format and the other in a textual format. Each prescription comprises two regular medications (same doses and moments of the day) and two irregular medications (different doses or different moments). For each prescription, participants must fill a virtual pillbox displayed on the screen as prescribed in the prescription. Prescriptions and pillboxes are displayed by a tablet software specifically designed to record in real time all participant's actions and related chronometric data. Half participants perform the task in the " tablet condition ", and the other half in the " touch-screen " condition. In the touch-screen condition an eye-tracker is used to record eye fixations and scanpaths in real time. Once the 2nd pillbox filling is finished a battery of cognitive tests and questionnaires is administered to participants to identify Pd subtypes of impaired performances.
The main hypothesis predicts an effect of the format of prescriptions. More precisely, it consists in two concurrent hypotheses. H1a (the mental model model hypothesis): the table format should facilitate the pillboxes filling in the parkinsonian group and in the healthy volunteer group by facilitating the elaboration of an accurate mental model. H1b (the working memory load hypothesis): because parkinsonian patients are frequently impaired in visuospatial tasks, the tabular format could have no effect or could have a negative effect only in this group. A correlation between cognitive subtypes identified by cluster analyses and task performances is expected. Several secondary hypotheses will be tested.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
textual prescription healthy volunteers
reading a textual format prescription on a touch screen
Task consists in reading on a touch screen, or on a tablet, two fictive medication prescriptions. One is presented in a table format and the other in a textual format. Each prescription comprises two regular medications (same doses and moments of the day) and two irregular medications (different doses or different moments).
filling a virtual pillbox displayed on the screen as prescribed in the prescription
filling a virtual pillbox displayed on the screen as prescribed in the prescription
eye-tracker
In the touch-screen condition an eye-tracker is used to record eye fixations and scanpaths in real time.
cognitive tests and questionary
Once the 2nd pillbox filling is finished a battery of cognitive tests and questionnaires is administered to participants to identify Pd subtypes of impaired performances.
table prescription healthy volunteers
reading a table format prescription on a touch screen
Task consists in reading on a touch screen, or on a tablet, two fictive medication prescriptions. One is presented in a table format and the other in a textual format. Each prescription comprises two regular medications (same doses and moments of the day) and two irregular medications (different doses or different moments).
filling a virtual pillbox displayed on the screen as prescribed in the prescription
filling a virtual pillbox displayed on the screen as prescribed in the prescription
eye-tracker
In the touch-screen condition an eye-tracker is used to record eye fixations and scanpaths in real time.
cognitive tests and questionary
Once the 2nd pillbox filling is finished a battery of cognitive tests and questionnaires is administered to participants to identify Pd subtypes of impaired performances.
textual prescription Parkinson's disease patients
reading a textual format prescription on a touch screen
Task consists in reading on a touch screen, or on a tablet, two fictive medication prescriptions. One is presented in a table format and the other in a textual format. Each prescription comprises two regular medications (same doses and moments of the day) and two irregular medications (different doses or different moments).
filling a virtual pillbox displayed on the screen as prescribed in the prescription
filling a virtual pillbox displayed on the screen as prescribed in the prescription
eye-tracker
In the touch-screen condition an eye-tracker is used to record eye fixations and scanpaths in real time.
cognitive tests and questionary
Once the 2nd pillbox filling is finished a battery of cognitive tests and questionnaires is administered to participants to identify Pd subtypes of impaired performances.
table prescription Parkinson's disease patient
reading a table format prescription on a touch screen
Task consists in reading on a touch screen, or on a tablet, two fictive medication prescriptions. One is presented in a table format and the other in a textual format. Each prescription comprises two regular medications (same doses and moments of the day) and two irregular medications (different doses or different moments).
filling a virtual pillbox displayed on the screen as prescribed in the prescription
filling a virtual pillbox displayed on the screen as prescribed in the prescription
eye-tracker
In the touch-screen condition an eye-tracker is used to record eye fixations and scanpaths in real time.
cognitive tests and questionary
Once the 2nd pillbox filling is finished a battery of cognitive tests and questionnaires is administered to participants to identify Pd subtypes of impaired performances.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
reading a table format prescription on a touch screen
Task consists in reading on a touch screen, or on a tablet, two fictive medication prescriptions. One is presented in a table format and the other in a textual format. Each prescription comprises two regular medications (same doses and moments of the day) and two irregular medications (different doses or different moments).
reading a textual format prescription on a touch screen
Task consists in reading on a touch screen, or on a tablet, two fictive medication prescriptions. One is presented in a table format and the other in a textual format. Each prescription comprises two regular medications (same doses and moments of the day) and two irregular medications (different doses or different moments).
filling a virtual pillbox displayed on the screen as prescribed in the prescription
filling a virtual pillbox displayed on the screen as prescribed in the prescription
eye-tracker
In the touch-screen condition an eye-tracker is used to record eye fixations and scanpaths in real time.
cognitive tests and questionary
Once the 2nd pillbox filling is finished a battery of cognitive tests and questionnaires is administered to participants to identify Pd subtypes of impaired performances.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* be able to sign the written informed consent form and must have reached the age of majority.
* Patients with Pd must have been diagnosed by a neurologist of the Amiens CHU (University Hospital Centre) more than 3 years ago, and must be in a ON period when participating to the two sessions.
Exclusion Criteria
* dyschromatopsias,
* not corrected visual acuity,
* dementia indicated by a Mini Mental State Examination score \< 24,
* alcoholism or other drug addictions conditions known to impair mental status
* acute psychiatric or neurologic illness,
* failing to the training phase.
* Patients with Pd must not have other parkinsonian syndrome nor neurological, psychiatric or motor disorders, other than due to Pd.
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre Hospitalier Universitaire, Amiens
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU Amiens-Picardie
Amiens, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PI2017_843_0025
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.