- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04103827
Qoos Use Sustaining Health Among patIents hOspitalized in Geriatric mediciNe (QUSHION) (QUSHION)
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).
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Contacts and Locations
Study Locations
-
-
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Angers, France, 49933 cedex 9
- Angers University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
Inclusion Criteria:
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
Healthcare team :
- geriatric medicine department's staff of Angers University Hospital
- Aged 18 years old and over
Exclusion Criteria:
- To be under legal protection
- Refusal of participating
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
Usability of "Le Qoos" will be assessed using a validated usability questionnaire
|
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.
|
Usability of "Le Qoos" will be assessed using a validated usability questionnaire
|
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.
|
Usability of "Le Qoos" will be assessed using a validated usability questionnaire
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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During the 48 hours before the discharge of the hospital
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfaction of the users following the use of the device "Le Qoos"
Time Frame: During the 48 hours before the discharge of the hospital
|
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.
|
During the 48 hours before the discharge of the hospital
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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 frequency of use will be described using a non-validated questionnary based on 4 closed questions.
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During the 48 hours before the discharge of the hospital
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The most appreciated ergonomic elements
Time Frame: During the 48 hours before the discharge of the hospital
|
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.
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During the 48 hours before the discharge of the hospital
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Areas of improvment regarding ergonomics of "Le Qoos"
Time Frame: During the 48 hours before the discharge of the hospital
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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,
|
During the 48 hours before the discharge of the hospital
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cedric ANNWEILER, MD, PhD, Angers University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2019/40
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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