Qoos Use Sustaining Health Among patIents hOspitalized in Geriatric mediciNe (QUSHION) (QUSHION)

February 20, 2020 updated by: University Hospital, Angers

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

Withdrawn

Intervention / Treatment

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Angers, France, 49933 cedex 9
        • Angers University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
During the 48 hours before the discharge of the hospital

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
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.
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
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.
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Cedric ANNWEILER, MD, PhD, Angers University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2019

Primary Completion (Anticipated)

September 16, 2020

Study Completion (Anticipated)

October 5, 2020

Study Registration Dates

First Submitted

September 13, 2019

First Submitted That Met QC Criteria

September 24, 2019

First Posted (Actual)

September 25, 2019

Study Record Updates

Last Update Posted (Actual)

February 24, 2020

Last Update Submitted That Met QC Criteria

February 20, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2019/40

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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