Study of Comprehension and Execution of Medication Prescriptions in Parkinsonian Patients and Healthy Volunteers

NCT03976505 | Completed

• 1 other identifier: PI2017_843_0025
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

Many patients with Parkinson's disease (Pd) don't respect medication prescriptions. Non-adherence is caused by several factors among which three play an important role: treatment complexity, cognitive decline, and patient-provider communication. One way for improving medication adherence in these patients is to identify the best way for adapting medication prescription presentation to these patients. This study is focused on prescriptions displayed on touch-screens and tablets. 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.

Conditions

Parkinson Disease

Keywords

medication prescriptions; eye-tracking; non-adherence; medication schedule

Outcome Measures

Primary Outcomes (1)

• Execution performance

  concordance rate between prescription and pillbox filling

  3 month

Study Arms (4)

textual prescription healthy volunteers

ACTIVE COMPARATOR

Other: reading a textual format prescription on a touch screen; Other: filling a virtual pillbox displayed on the screen as prescribed in the prescription; Other: eye-tracker; Other: cognitive tests and questionary

table prescription healthy volunteers

ACTIVE COMPARATOR

Other: reading a table format prescription on a touch screen; Other: filling a virtual pillbox displayed on the screen as prescribed in the prescription; Other: eye-tracker; Other: cognitive tests and questionary

textual prescription Parkinson's disease patients

EXPERIMENTAL

Other: reading a textual format prescription on a touch screen; Other: filling a virtual pillbox displayed on the screen as prescribed in the prescription; Other: eye-tracker; Other: cognitive tests and questionary

table prescription Parkinson's disease patient

EXPERIMENTAL

Other: reading a table format prescription on a touch screen; Other: filling a virtual pillbox displayed on the screen as prescribed in the prescription; Other: eye-tracker; Other: cognitive tests and questionary

Interventions

reading a table format prescription on a touch screen OTHER

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).

table prescription Parkinson's disease patient; table prescription healthy volunteers

reading a textual format prescription on a touch screen OTHER

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).

textual prescription Parkinson's disease patients; textual prescription healthy volunteers

filling a virtual pillbox displayed on the screen as prescribed in the prescription OTHER

filling a virtual pillbox displayed on the screen as prescribed in the prescription

table prescription Parkinson's disease patient; table prescription healthy volunteers; textual prescription Parkinson's disease patients; textual prescription healthy volunteers

eye-tracker OTHER

In the touch-screen condition an eye-tracker is used to record eye fixations and scanpaths in real time.

table prescription Parkinson's disease patient; table prescription healthy volunteers; textual prescription Parkinson's disease patients; textual prescription healthy volunteers

cognitive tests and questionary OTHER

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; table prescription healthy volunteers; textual prescription Parkinson's disease patients; textual prescription healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all participants must have French as mother tongue,
• 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.

You may not qualify if:

• photosensitive epilepsy,
• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens-Picardie

Amiens, 80054, France

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is exploratory, cross-sectional, experimental and monocentric. The experimental design is a split-plot 2(Group: parkinsonian patients vs. healthy volunteers) X 2(Condition: tablet vs. touch-screen + eye-tracker) X 2(Medication type: regular vs. irregular) X 2(Prescription format: table vs. textual) split-plot design in which Group and Condition are between-participants variables and Medication type and Prescription format are within-participants variables.

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: June 6, 2019
• Study Start: June 15, 2018
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)