Old AgeQUSHIONNCT04103827
Qoos Use Sustaining Health Among patIents hOspitalized in Geriatric mediciNe (QUSHION)
An observational study of Old Age and Usability, run by University Hospital, Angers at 1 site in France.
Trial summary
Falls are a frequent and serious problem in old people. It is estimated that one-third of subjects over 65 years of age and 50% of those over 85 years of age have at least one fall per year (1). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Old Age, Usability, Satisfaction
- What is being tested?
- usability assessment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 16 Sep 2019to 5 Oct 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 65 years and older
- All sexes
- Healthy volunteers accepted
- 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
- To be under legal protection
- Refusal of participating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Usability Assessment of a Device to Promote Physical Activity for Old Patients Hospitalized
Falls are a frequent and serious problem in old people. It is estimated that one-third of subjects over 65 years of age and 50% of those over 85 years of age have at least one fall per year (1). The traumatic and psychological consequences of falls contribute to the loss of functional independence and lead to early institutionalization (2).
All activities of daily living require us to maintain a state of postural balance, whether standing, sitting, static or dynamic. Thus, good coordination is essential to maintain balance, reflecting both peripheral (muscular) and central (cognitive) motor control (3,4). Coordination skills between posture and movement decline during aging without associated disorder, and even more so when this aging is associated by cognitive disorders (5,6).
Read more
On the contrary, as part of a balance rehabilitation program, an adapted training allows the partial recovery of the balance management process in elderly subjects who fall (7).
Le Qoos® by LudHealth is technical foam equipment, which can be installed on the wall, to practice various physical exercises. It can therefore be used as a simple support, leaning on with hands, arms, feet or even the head, exerting contact points, pressures or even impacts with more or less force. Le Qoos® is an equipment that allows to perform, on the same object, gentle or tonic exercises, balance, flexibility, sheathing or muscle strengthening while having fun.
We hypothesize that cognitive-physical stimulation workshops based on the use of the device Le Qoos® and is environment are i) adapted to geriatric fall prevention issues, ii) accessible to elderly hospitalized patients and health professionals, and iii) effective and safe to maintain and/or recover postural balance in elderly hospitalized patients.
First step of this work is to assess whether "Le Qoos" is considered as usable par end-users of the device.
Read the detailed description
This satisfaction survey will be carried out in the Geriatrics department of the University Hospital of Angers. Actually, Le Qoos and is environment is installed in a hospitalisation room of the geriatric unit. When the patient entered the room, a first series of questions are asked a priori concerning the device. These questions are also asked to the relatives of the patient if any, and to the professional caregivers of the unit. After this first series of questions, a list of possible exercises is given to the patients, regrading is functional capabilities according to the EGS-1, with some explanations. The proposed exercises correspond to 3 selected actions based on the results of scientific research conducted by the team at the University Hospital of Angers to prevent the risks of iatrogenic dependence. Then, the patient and is relatives, if any, are free to use the device during the all hospitalisation. During the 48h before the discharge from the hospital, a second list of questions will be asked to assess the usability and the satisfaction concerning the device.
- Conditions
- Old Age, Usability, Satisfaction
- Being tested
- usability assessment
- Keywords
- Usability, Elderly, Old people, Physical activity, Balance
- Medical subject headings
- Personal Satisfaction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
usability assessmentOther
Usability of "Le Qoos" will be assessed using a validated usability questionnaire
| Study group | Role | What they receive |
|---|---|---|
| old patients | During the first 24 hours of the hospitalisation in the equiped room and before the presentation of the device, A first series of questions will be asked a priori to the patients. Patient will freely use "Le Qoos" during all his hospitalisation. After this use, a survey concerning the usability of "Le Qoos" will be administered to the patient, during the 48 hours before his discharge from hospital. Receives: Other: usability assessment | |
| relatives / unformal caregivers | Before the presentation of the device, a first series of questions will be asked a priori to the unformal caregiver. Unformal caregiver will freely use "Le Qoos" during the hospitalization of his relative. After this use, a survey concerning the usability of "Le Qoos" will be administered to the unformal caregivers, 48 hours before the discharge of his hospitalized relative from hospital. Receives: Other: usability assessment | |
| profesional caregivers | After the inclusion of all expected patients and relatives, a survey concerning the usability of "Le Qoos" 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 device "Le Qoos"
The usability will be assessed using the validated System Usability Scale (SUS). SUS scale range from 0 to 100. The mean score obtained by users will be calculated. A score over 50 could be considered as acceptable usability. A score over 65 could be considered as good usability.
Measured: During the 48 hours before the discharge of the hospital
Secondary outcomes (4)
Satisfaction of the users following the use of the device "Le Qoos"
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 device "Le Qoos" 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
The most appreciated ergonomic elements
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
Areas of improvment regarding ergonomics of "Le Qoos"
A single open question will be asked for users concerning elements to improve. A qualitative thematic analyze of the verbatim will be realized to identify the elements to improve,
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 posted25 Sep 2019
- Study start16 Sep 2019
- Primary completion16 Sep 2020 (estimated)
- Study completion5 Oct 2020 (estimated)
Why it stopped: no patient included after 6 month of enrollement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old AgeStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Cédric Annweiler, MD, PhD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103827
- Sponsor's protocol ID
- 2019/40
- Acronym
- QUSHION
- Status last verified
- Feb 2020
- First submitted
- 13 Sep 2019
- Last updated
- 24 Feb 2020
- 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 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability Assessment of a Device to Promote Physical Activity for Old Patients Hospitalized
- ClinicalTrials.gov ID
- NCT04103827
- Acronym / sponsor ID
- QUSHION / 2019/40
- Conditions
- Old Age, Usability, Satisfaction
- Keywords
- Usability, Elderly, Old people, Physical activity, Balance
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no patient included after 6 month of enrollement
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 16 Sep 2020 (estimated)
- Study completion
- 5 Oct 2020 (estimated)
- First posted
- 25 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.
Falls are a frequent and serious problem in old people. It is estimated that one-third of subjects over 65 years of age and 50% of those over 85 years of age have at least one fall per year (1). The traumatic and psychological consequences of falls contribute to the loss of functional independence and lead to early institutionalization (2).
All activities of daily living require us to maintain a state of postural balance, whether standing, sitting, static or dynamic. Thus, good coordination is essential to maintain balance, reflecting both peripheral (muscular) and central (cognitive) motor control (3,4). Coordination skills between posture and movement decline during aging without associated disorder, and even more so when this aging is associated by cognitive disorders (5,6).
On the contrary, as part of a balance rehabilitation program, an adapted training allows the partial recovery of the balance management process in elderly subjects who fall (7).
Le Qoos® by LudHealth is technical foam equipment, which can be installed on the wall, to practice various physical exercises. It can therefore be used as a simple support, leaning on with hands, arms, feet or even the head, exerting contact points, pressures or even impacts with more or less force. Le Qoos® is an equipment that allows to perform, on the same object, gentle or tonic exercises, balance, flexibility, sheathing or muscle strengthening while having fun.
We hypothesize that cognitive-physical stimulation workshops based on the use of the device Le Qoos® and is environment are i) adapted to geriatric fall prevention issues, ii) accessible to elderly hospitalized patients and health professionals, and iii) effective and safe to maintain and/or recover postural balance in elderly hospitalized patients.
First step of this work is to assess whether "Le Qoos" is considered as usable par end-users of the device.
Detailed description
This satisfaction survey will be carried out in the Geriatrics department of the University Hospital of Angers. Actually, Le Qoos and is environment is installed in a hospitalisation room of the geriatric unit. When the patient entered the room, a first series of questions are asked a priori concerning the device. These questions are also asked to the relatives of the patient if any, and to the professional caregivers of the unit. After this first series of questions, a list of possible exercises is given to the patients, regrading is functional capabilities according to the EGS-1, with some explanations. The proposed exercises correspond to 3 selected actions based on the results of scientific research conducted by the team at the University Hospital of Angers to prevent the risks of iatrogenic dependence. Then, the patient and is relatives, if any, are free to use the device during the all hospitalisation. During the 48h before the discharge from the hospital, a second list of questions will be asked to assess the usability and the satisfaction concerning the device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| old patients | – | Other: usability assessmentDuring the first 24 hours of the hospitalisation in the equiped room and before the presentation of the device, A first series of questions will be asked a priori to the patients. Patient will freely use "Le Qoos" during all his hospitalisation. After this use, a survey concerning the usability of "Le Qoos" will be administered to the patient, during the 48 hours before his discharge from hospital. |
| relatives / unformal caregivers | – | Other: usability assessmentBefore the presentation of the device, a first series of questions will be asked a priori to the unformal caregiver. Unformal caregiver will freely use "Le Qoos" during the hospitalization of his relative. After this use, a survey concerning the usability of "Le Qoos" will be administered to the unformal caregivers, 48 hours before the discharge of his hospitalized relative from hospital. |
| profesional caregivers | – | Other: usability assessmentAfter the inclusion of all expected patients and relatives, a survey concerning the usability of "Le Qoos" will be administered to professional caregivers. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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 (2 listed)
- To be under legal protection
- 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 "Le Qoos" will be assessed using a validated usability questionnaire | Other | old patients, profesional caregivers, relatives / unformal caregivers |
Primary outcome
Usability of the device "Le Qoos"
Time frame: During the 48 hours before the discharge of the hospital
The usability will be assessed using the validated System Usability Scale (SUS). SUS scale range from 0 to 100. The mean score obtained by users will be calculated. A score over 50 could be considered as acceptable usability. A score over 65 could be considered as good usability.
4 secondary outcomes
Satisfaction of the users following the use of the device "Le Qoos"
Time frame: During the 48 hours before the discharge of the hospital
Frequency of use of the device "Le Qoos" by elderly hospitalized patients.
Time frame: During the 48 hours before the discharge of the hospital
The most appreciated ergonomic elements
Time frame: During the 48 hours before the discharge of the hospital
Areas of improvment regarding ergonomics of "Le Qoos"
Time frame: During the 48 hours before the discharge of the hospital
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
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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.
Cédric 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 and Usability, 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 2 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: withdrawn, as of the sponsor's last update on 24 Feb 2020. 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 was withdrawn before enrolling participants, so there are no results.
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?
Usability of the device "Le Qoos" (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 24 Feb 2020.