Clinical trial NCT03116204: Validation of a SOFMER Activity Scale
Official title: Validation of a Score Assessing Physical and Cognitive Activities of Patients in Follow-up Care and Rehabilitation Departments: the SOFMER Activity Score
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients Hospitalized in a FRC Department
Keywords: Dependency
FRC department
scale validation
validity
reliability
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 450
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in a FRC department

Brief summary: A person's dependency is defined as the total or partial inability to perform without helps the necessary activities of daily life due to activity limitations in the usual environment. The consequence is a restriction of participation. In physical and Rehabilitation Medicine (PRM), dependency impacts the healthcare team activity at several levels: patient's referral and care plan, conditions of home return and resumption of course of life, burden of care assessment and care teams management...

The main goal of this project is the validation of a score assessing physical and cognitive activities of patients in follow-up care and rehabilitation (FRC) departments based on the ICF model (International Classification of Functioning, Disability and Health) : the SOFMER Activity Scale (SAS).

We want to propose a French generic scale allowing quantifying precisely the dependence and burden of care of patients in FRC departments. This scale needs to be valid, easy to apply, easy to learn, reproducible, sensitive to change and common to adult subjects, children and elderly.


Eligibility criteria: Inclusion Criteria:

* Men and women aged 2 years old
* Hospitalized in the participating department for at least 4 days
* For the responsiveness study : patients hospitalized in the FRC departments for obesity, spinal cord injuries, post-stroke rehabilitation or cardiorespiratory rehabilitation after cardiac surgery

Exclusion Criteria:

* Non-recipient of French Social Security

Primary outcomes:
measure: Assessment of the validity of SAS
timeFrame: Day 0
measure: Assessment of the reliability of SAS.
timeFrame: Day 7
Secondary outcomes:
measure: Study of SAS responsiveness
timeFrame: 6 months
measure: Study of invariance of SAS: invariance of the classification between age and sex classes.
timeFrame: day 0
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre SSR Les Capucins
city: Berck
country: France
facility: Etablissement Hopale-Centre Calvé
city: Brest
country: France
facility: Service SSRS Enfants et Adolescents, Fondation Ildys
city: Garche
country: France
facility: Médecine physique et réadaptation - Hôpital Raymond Poincaré - APHP
city: Lyon
country: France
facility: Ctre Médico-Chir Réadapt Des Massues
city: Lyon
country: France
facility: Service de Médecine physique et Réadaptation - Hôpital Henry Gabrielle
city: Paris
country: France
facility: Service de Médecine Physique et de Réadaptation - F.Widal - APHP
city: Saint-Étienne
country: France
facility: Service de Médecine Physique et Réadaptation - Pôle Couple Mère-Enfant - HOPITAL DE BELLEVUE
city: Échirolles
country: France
facility: Département de Rééducation Neurologique - Hôpital Sud - CHU de Grenoble
Study officials:
affiliation: Hospices Civils de Lyon
name: Carole VUILLEROT
role: PRINCIPAL_INVESTIGATOR
References: