Old Age; DebilityTikTacNCT04091152
TIKeasy TAblet satisfaCtion (TikTac)
An observational study of Old Age; Debility and Satisfaction, run by University Hospital, Angers at 1 site in France.
Trial summary
In the last ten years, gerontechnology is becoming an increasing topic in geriatric medicine. Nevertheless, there are still few studies assessing the usability of technologies in old patients, especially when they are hospitalized. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Old Age; Debility, Satisfaction
- What is being tested?
- usability assessment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 19 Sep 2019to 25 Sep 2020
- Phase
- Observational
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients are recruited during their hospitalisation in geriatric medicine. Relatives / unformal caregivers are recruited during the hospitalisation of patients in geriatric medicine. Professionnal caregivers are recruited in the acute care geriatric unit.
Who may be able to join
- Patients :
- Aged 65 years old and over
- To be hospitalised in geriatric medicine department of Angers University Hospital
- Caregivers:
- Family members or relatives
- Aged 18 years old and over
Show all 9Show fewer
- Healthcare team :
- geriatric medicine department's staff of Angers University Hospital
- Aged 18 years old and over
Who cannot join
- Patients :
- Existence of a delirium revealed by the Confusion Assessment Method
- To be under legal protection
- Refusal of participating
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Angers University Hospital
Angers, 49933 cedex 9
Cédric ANNWEILER, MD, PhD, +33 2 41 35 47 25, cedric.annweiler@chu-angers.fr
Cédric ANNWEILER, MD, PhD
About this study
Official title: Usability Assessment of a Tablet PC Designed for Old Patients: the "Ardoiz" Tikeasy Tablet.
In the last ten years, gerontechnology is becoming an increasing topic in geriatric medicine. Nevertheless, there are still few studies assessing the usability of technologies in old patients, especially when they are hospitalized. Moreover, it has been shown that new technologies could be a source of ageism, thence the importance of involving the old people in the development of these technologies.
Tik easy is a subsidiary of La Poste Company. Tik easy as designed a new tablet PC for old people. Research tends to show that the use of tablet PC can promote health and well-aging, and delay cognitive decline. In this study, we want to give a free access to "Ardoiz", the tablet PC designed by Tik easy, for old patients hospitalized in a geriatric acute care unit. The "Ardoiz" tablet PC allows to:
- Maintain the family and social bond (send and receive messages, share photos and videos, call remotely between the patient and his family)
- Discovering the Internet at his own pace (browse the Internet with daily updated contents such as news, content on cooking, music, etc.).
- Prevent cognitive aging (stimulate cognitive abilities with the DYNSEO games).
- Facilitate online administrative procedures.
Read the detailed description
The "Ardoiz" tablet PC will be given to old patients hospitalized in the acute care geriatric unit of the university hospital of Angers. Patients and their relatives will have a free access to "Ardoiz" during their hospitalisation. The maximum duration of use will be 9 days. After the using period, a survey will be proposed to the patients and their relatives. This survey include questions concerning usability (using the validated SUS questionnaire), ergonomics (using non validated specific questionnaire with closed questions oriented on "Ardoiz" device), satisfaction (general and specific questions using non validated questionnaire with forced choice Likert scale in 4 points and closed questions). After recruiting all expected patients and relatives; the survey will also be submitted to the professional caregivers of the unit.
- Conditions
- Old Age; Debility, Satisfaction
- Being tested
- usability assessment
- Keywords
- old poeple, elderly, usability, ergonomy, tablet PC
- Medical subject headings
- Frailty, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
usability assessmentOther
Usability of "ardoiz" will be assesse using a validated usability questionnary
| Study group | Role | What they receive |
|---|---|---|
| old patients | Patient will freely use "Ardoiz" during their hospitalisation for a maximum of 9 days.
After this use, a survey concerning the usability of "Ardoiz" will be administered to the patient, before their discharge from hospital. Receives: Other: usability assessment | |
| relatives / unformal caregivers | Unformal caregivers will freely use "Ardoiz" during the hospitalization of their relatives and a maximum of 9 days.
After this use, a survey concerning the usability of "Ardoiz" will be administered to the unformal caregivers, before the discharge of their hospitalized relatives from hospital. Receives: Other: usability assessment | |
| profesionnal caregivers | After the inclusion of all expected patients and relatives, a survey concerning the usability of "Ardoiz" will be administered to professional caregivers. Receives: Other: usability assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of the Ardoiz® tablet PC
The usability will be assessed using the validated System Usability Scale (SUS). The mean score obtained by users will be calculated. "Ardoiz" will be considered as usable if the mean score on the SUS is equal or over 70 on 100.
Measured: During the 48 hours before the discharge of the hospital
Secondary outcomes (5)
Satisfaction of the users following the use of the Ardoiz® tablet PC.
The satisfaction will be assessed using a non-validated satisfaction questionnaire based on a forced choice Likert scale in 4 points from 1 to 4. The mean score obtained by users will be used. Users will be considered as satisfied if the mean score is over 2 on 4.
Measured: During the 48 hours before the discharge of the hospital
Frequency of use of the Ardoiz® tablet PC by elderly hospitalized patients.
The frequency of use will be described using a non-validated questionnary based on 4 closed questions.
Measured: During the 48 hours before the discharge of the hospital
Most appreciated ergonomic elements for the users
The ergonomic elements will be assessed using a single choice closed liste of ergonomic elements. The most ergonomic elements will be ranked in descending order of citation by users.
Measured: During the 48 hours before the discharge of the hospital
Improvement areas regarding the ergonomics of the Ardoiz® tablet PC.
The ergonomic elements will be assessed using a single choice closed liste of ergonomic elements. The less ergonomic elements will be ranked in descending order of citation by users.
Measured: During the 48 hours before the discharge of the hospital
Improvement areas regarding the functions of the Ardoiz® tablet PC.
The satisfaction concerning functions of "Ardoiz" will be assessed using a single choice closed liste of functions. The less appreciated functions will be ranked in descending order of citation by users.
Measured: During the 48 hours before the discharge of the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start19 Sep 2019
- Primary completion16 Sep 2020 (estimated)
- Study completion25 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old Age; DebilityStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Cedric Annweiler, MD, PhD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091152
- Sponsor's protocol ID
- 2019/41
- Acronym
- TikTac
- Status last verified
- Sep 2019
- First submitted
- 12 Sep 2019
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability Assessment of a Tablet PC Designed for Old Patients: the "Ardoiz" Tikeasy Tablet.
- ClinicalTrials.gov ID
- NCT04091152
- Acronym / sponsor ID
- TikTac / 2019/41
- Conditions
- Old Age; Debility, Satisfaction
- Keywords
- old poeple, elderly, usability, ergonomy, tablet PC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 16 Sep 2020 (estimated)
- Study completion
- 25 Sep 2020 (estimated)
- First posted
- 16 Sep 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.
In the last ten years, gerontechnology is becoming an increasing topic in geriatric medicine. Nevertheless, there are still few studies assessing the usability of technologies in old patients, especially when they are hospitalized. Moreover, it has been shown that new technologies could be a source of ageism, thence the importance of involving the old people in the development of these technologies.
Tik easy is a subsidiary of La Poste Company. Tik easy as designed a new tablet PC for old people. Research tends to show that the use of tablet PC can promote health and well-aging, and delay cognitive decline. In this study, we want to give a free access to "Ardoiz", the tablet PC designed by Tik easy, for old patients hospitalized in a geriatric acute care unit. The "Ardoiz" tablet PC allows to:
- Maintain the family and social bond (send and receive messages, share photos and videos, call remotely between the patient and his family)
- Discovering the Internet at his own pace (browse the Internet with daily updated contents such as news, content on cooking, music, etc.).
- Prevent cognitive aging (stimulate cognitive abilities with the DYNSEO games).
- Facilitate online administrative procedures.
Detailed description
The "Ardoiz" tablet PC will be given to old patients hospitalized in the acute care geriatric unit of the university hospital of Angers. Patients and their relatives will have a free access to "Ardoiz" during their hospitalisation. The maximum duration of use will be 9 days. After the using period, a survey will be proposed to the patients and their relatives. This survey include questions concerning usability (using the validated SUS questionnaire), ergonomics (using non validated specific questionnaire with closed questions oriented on "Ardoiz" device), satisfaction (general and specific questions using non validated questionnaire with forced choice Likert scale in 4 points and closed questions). After recruiting all expected patients and relatives; the survey will also be submitted to the professional caregivers of the unit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| old patients | – | Other: usability assessmentPatient will freely use "Ardoiz" during their hospitalisation for a maximum of 9 days. After this use, a survey concerning the usability of "Ardoiz" will be administered to the patient, before their discharge from hospital. |
| relatives / unformal caregivers | – | Other: usability assessmentUnformal caregivers will freely use "Ardoiz" during the hospitalization of their relatives and a maximum of 9 days. After this use, a survey concerning the usability of "Ardoiz" will be administered to the unformal caregivers, before the discharge of their hospitalized relatives from hospital. |
| profesionnal caregivers | – | Other: usability assessmentAfter the inclusion of all expected patients and relatives, a survey concerning the usability of "Ardoiz" will be administered to professional caregivers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are recruited during their hospitalisation in geriatric medicine. Relatives / unformal caregivers are recruited during the hospitalisation of patients in geriatric medicine. Professionnal caregivers are recruited in the acute care geriatric unit.
Key inclusion criteria (9 listed)
- Patients :
- Caregivers:
- Healthcare team :
Key exclusion criteria (4 listed)
- Patients :
- Refusal of participating
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 |
|---|---|---|
| usability assessmentUsability of "ardoiz" will be assesse using a validated usability questionnary | Other | old patients, profesionnal caregivers, relatives / unformal caregivers |
Primary outcome
Usability of the Ardoiz® tablet PC
Time frame: During the 48 hours before the discharge of the hospital
The usability will be assessed using the validated System Usability Scale (SUS). The mean score obtained by users will be calculated. "Ardoiz" will be considered as usable if the mean score on the SUS is equal or over 70 on 100.
5 secondary outcomes
Satisfaction of the users following the use of the Ardoiz® tablet PC.
Time frame: During the 48 hours before the discharge of the hospital
Frequency of use of the Ardoiz® tablet PC by elderly hospitalized patients.
Time frame: During the 48 hours before the discharge of the hospital
Most appreciated ergonomic elements for the users
Time frame: During the 48 hours before the discharge of the hospital
Improvement areas regarding the ergonomics of the Ardoiz® tablet PC.
Time frame: During the 48 hours before the discharge of the hospital
Improvement areas regarding the functions of the Ardoiz® tablet PC.
Time frame: During the 48 hours before the discharge of the hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
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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.
Cedric Annweiler, MD, PhD principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Old Age; Debility and Satisfaction, run by University Hospital, Angers 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 9 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Oct 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cedric Annweiler, MD, PhD (0241354725 ext. +33, allegro@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of the Ardoiz® tablet PC (time frame: During the 48 hours before the discharge of the hospital). 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 1 Oct 2019.