Study of Comprehension and Execution of Medication Prescriptions in Parkinsonian Patients and Healthy Volunteers (TACTIPARK)
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
reading a table format prescription on a touch screen
reading a textual format prescription on a touch screen
filling a virtual pillbox displayed on the screen as prescribed in the prescription
eye-tracker
cognitive tests and questionary
Sponsored by
About this trial
This is an interventional other trial for Parkinson Disease focused on measuring medication prescriptions, eye-tracking, non-adherence, medication schedule
Eligibility Criteria
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.
Sites / Locations
- CHU Amiens-Picardie
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Experimental
Experimental
Arm Label
textual prescription healthy volunteers
table prescription healthy volunteers
textual prescription Parkinson's disease patients
table prescription Parkinson's disease patient
Arm Description
Outcomes
Primary Outcome Measures
Execution performance
concordance rate between prescription and pillbox filling
Secondary Outcome Measures
Full Information
NCT ID
NCT03976505
First Posted
April 18, 2018
Last Updated
March 21, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT03976505
Brief Title
Study of Comprehension and Execution of Medication Prescriptions in Parkinsonian Patients and Healthy Volunteers
Acronym
TACTIPARK
Official Title
Study of Comprehension and Execution of Medication Prescriptions Displayed on Touch-screens and Tablets in Parkinsonian Patients and Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
medication prescriptions, eye-tracking, non-adherence, medication schedule
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
textual prescription healthy volunteers
Arm Type
Active Comparator
Arm Title
table prescription healthy volunteers
Arm Type
Active Comparator
Arm Title
textual prescription Parkinson's disease patients
Arm Type
Experimental
Arm Title
table prescription Parkinson's disease patient
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
reading a table format prescription on a touch screen
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
reading a textual format prescription on a touch screen
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
filling a virtual pillbox displayed on the screen as prescribed in the prescription
Intervention Description
filling a virtual pillbox displayed on the screen as prescribed in the prescription
Intervention Type
Other
Intervention Name(s)
eye-tracker
Intervention Description
In the touch-screen condition an eye-tracker is used to record eye fixations and scanpaths in real time.
Intervention Type
Other
Intervention Name(s)
cognitive tests and questionary
Intervention Description
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.
Primary Outcome Measure Information:
Title
Execution performance
Description
concordance rate between prescription and pillbox filling
Time Frame
3 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
CHU Amiens-Picardie
City
Amiens
ZIP/Postal Code
80054
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Study of Comprehension and Execution of Medication Prescriptions in Parkinsonian Patients and Healthy Volunteers
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