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出境医 / 临床实验 / Study of Comprehension and Execution of Medication Prescriptions in Parkinsonian Patients and Healthy Volunteers (TACTIPARK)

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

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.


Condition or disease Intervention/treatment Phase
Parkinson Disease Other: reading a table format prescription on a touch screen 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 Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 258 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Other
Official Title: Study of Comprehension and Execution of Medication Prescriptions Displayed on Touch-screens and Tablets in Parkinsonian Patients and Healthy Volunteers
Actual Study Start Date : June 15, 2018
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021
Arms and Interventions
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: 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).

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: 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: 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).

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.

Outcome Measures
Primary Outcome Measures :
  1. Execution performance [ Time Frame: 3 month ]
    concordance rate between prescription and pillbox filling


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Pierre KRYSTKOWIAK 03-22-66-82-40 krystkowiak.pierre@chu-amiens.fr

Locations
Layout table for location information
France
CHU Amiens-Picardie Recruiting
Amiens, France, 80054
Contact: Pierre KRYSTKOWIAK    03-22-66-82-40    krystkowiak.pierre@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Tracking Information
First Submitted Date  ICMJE April 18, 2018
First Posted Date  ICMJE June 6, 2019
Last Update Posted Date June 6, 2019
Actual Study Start Date  ICMJE June 15, 2018
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
Execution performance [ Time Frame: 3 month ]
concordance rate between prescription and pillbox filling
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Comprehension and Execution of Medication Prescriptions in Parkinsonian Patients and Healthy Volunteers
Official Title  ICMJE Study of Comprehension and Execution of Medication Prescriptions Displayed on Touch-screens and Tablets in Parkinsonian Patients and Healthy Volunteers
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Other
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • 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).
  • 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.
Study Arms  ICMJE
  • Active Comparator: textual prescription healthy volunteers
    Interventions:
    • 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
  • Active Comparator: table prescription healthy volunteers
    Interventions:
    • 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
  • Experimental: textual prescription Parkinson's disease patients
    Interventions:
    • 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
  • Experimental: table prescription Parkinson's disease patient
    Interventions:
    • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 4, 2019)
258
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2021
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03976505
Other Study ID Numbers  ICMJE PI2017_843_0025
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire, Amiens
Study Sponsor  ICMJE Centre Hospitalier Universitaire, Amiens
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Centre Hospitalier Universitaire, Amiens
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP