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

March 21, 2023 updated by: Centre Hospitalier Universitaire, Amiens

Study of Comprehension and Execution of Medication Prescriptions Displayed on Touch-screens and Tablets in Parkinsonian Patients and Healthy Volunteers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Many Pd patients are non-adherent to their treatments. Because Pd patients are generally over 60 years old, suffer from cognitive disorders, and have complex medication regimens, taking medications as prescribed is a too complex cognitive task for them. It supposes the ability to understand the prescription, to plan and memorize the actions to carry out and to remember them while executing them. As prescriptions are communicated to patients via procedural documents, it should be possible to improve patient's comprehension by using a format suitable for their needs and characteristics. Previous studies with elderly people suggest that the table format is more effective than the textual format. However no study addressed this question with Pd patients.

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.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Amiens, France, 80054
        • CHU Amiens-Picardie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: textual prescription healthy volunteers
Other: 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).
Other: 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
Other: eye-tracker
In the touch-screen condition an eye-tracker is used to record eye fixations and scanpaths in real time.
Other: 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.
Active Comparator: table prescription healthy volunteers
Other: 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
Other: eye-tracker
In the touch-screen condition an eye-tracker is used to record eye fixations and scanpaths in real time.
Other: 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.
Other: 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).
Experimental: textual prescription Parkinson's disease patients
Other: 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).
Other: 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
Other: eye-tracker
In the touch-screen condition an eye-tracker is used to record eye fixations and scanpaths in real time.
Other: 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.
Experimental: table prescription Parkinson's disease patient
Other: 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
Other: eye-tracker
In the touch-screen condition an eye-tracker is used to record eye fixations and scanpaths in real time.
Other: 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.
Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Execution performance
Time Frame: 3 month
concordance rate between prescription and pillbox filling
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2018

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

April 18, 2018

First Submitted That Met QC Criteria

June 4, 2019

First Posted (Actual)

June 6, 2019

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2017_843_0025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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