Parkinson DiseaseTACTIPARKNCT03976505
Study of Comprehension and Execution of Medication Prescriptions in Parkinsonian Patients and Healthy Volunteers
A study testing reading a table format prescription on a touch screen, reading a textual format prescription on a touch screen and filling a virtual pillbox displayed on the screen as prescribed in the prescription in people with Parkinson Disease, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- reading a table format prescription on a touch screen, reading a textual format prescription on a touch screen and filling a virtual pillbox displayed on the screen as prescribed in the prescription
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2018to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- 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
- Keywords
- medication prescriptions, eye-tracking, non-adherence, medication schedule
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reading a table format prescription on a touch screenOther
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).
reading a textual format prescription on a touch screenOther
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).
filling a virtual pillbox displayed on the screen as prescribed in the prescriptionOther
filling a virtual pillbox displayed on the screen as prescribed in the prescription
eye-trackerOther
In the touch-screen condition an eye-tracker is used to record eye fixations and scanpaths in real time.
cognitive tests and questionaryOther
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 group | Role | What they receive |
|---|---|---|
| textual prescription healthy volunteers | Active comparator | Not described Receives: 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 | Not described Receives: 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 | Not described Receives: 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 | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Execution performance
concordance rate between prescription and pillbox filling
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start15 Jun 2018
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976505
- Sponsor's protocol ID
- PI2017_843_0025
- Acronym
- TACTIPARK
- Status last verified
- Mar 2023
- First submitted
- 18 Apr 2018
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Comprehension and Execution of Medication Prescriptions Displayed on Touch-screens and Tablets in Parkinsonian Patients and Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03976505
- Acronym / sponsor ID
- TACTIPARK / PI2017_843_0025
- Conditions
- Parkinson Disease
- Keywords
- medication prescriptions, eye-tracking, non-adherence, medication schedule
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reading a table format prescription on a touch screenTask 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 | table prescription Parkinson's disease patient, table prescription healthy volunteers |
| reading a textual format prescription on a touch screenTask 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 | textual prescription Parkinson's disease patients, textual prescription healthy volunteers |
| filling a virtual pillbox displayed on the screen as prescribed in the prescriptionfilling a virtual pillbox displayed on the screen as prescribed in the prescription | Other | table prescription Parkinson's disease patient, table prescription healthy volunteers, textual prescription Parkinson's disease patients, textual prescription healthy volunteers |
| eye-trackerIn the touch-screen condition an eye-tracker is used to record eye fixations and scanpaths in real time. | Other | table prescription Parkinson's disease patient, table prescription healthy volunteers, textual prescription Parkinson's disease patients, textual prescription healthy volunteers |
| cognitive tests and questionaryOnce 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 | table prescription Parkinson's disease patient, table prescription healthy volunteers, textual prescription Parkinson's disease patients, textual prescription healthy volunteers |
Primary outcome
Execution performance
Time frame: 3 month
concordance rate between prescription and pillbox filling
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reading a table format prescription on a touch screen, reading a textual format prescription on a touch screen and filling a virtual pillbox displayed on the screen as prescribed in the prescription in people with Parkinson Disease, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Execution performance (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.