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 |
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 (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 |
Arm | Intervention/treatment |
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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.
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pierre KRYSTKOWIAK | 03-22-66-82-40 | krystkowiak.pierre@chu-amiens.fr |
France | |
CHU Amiens-Picardie | Recruiting |
Amiens, France, 80054 | |
Contact: Pierre KRYSTKOWIAK 03-22-66-82-40 krystkowiak.pierre@chu-amiens.fr |
Tracking Information | |||||
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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 |
Execution performance [ Time Frame: 3 month ] concordance rate between prescription and pillbox filling
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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. |
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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. |
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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 |
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Condition ICMJE | Parkinson Disease | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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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 |