SAS: Validation of a SOFMER Activity Scale

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Unknown status

CT.gov ID

NCT03116204

Collaborator

(none)

450

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Patients Hospitalized in a FRC Department	Other: Assessment of score SAS

Study Design

Study Type:

Observational

Anticipated Enrollment :

450 participants

Observational Model:

Ecologic or Community

Time Perspective:

Prospective

Official Title:

Validation of a Score Assessing Physical and Cognitive Activities of Patients in Follow-up Care and Rehabilitation Departments: the SOFMER Activity Score

Actual Study Start Date :

Nov 21, 2018

Anticipated Primary Completion Date :

May 21, 2020

Anticipated Study Completion Date :

May 21, 2020

Arms and Interventions

Arm	Intervention/Treatment
Patients hospitalized in a FRC department	Other: Assessment of score SAS Assessment of a score assessing physical and cognitive activities of patients in follow-up care and rehabilitation departments

Arm

Intervention/Treatment

Patients hospitalized in a FRC department

Other: Assessment of score SAS

Assessment of a score assessing physical and cognitive activities of patients in follow-up care and rehabilitation departments

Outcome Measures

Primary Outcome Measures

Assessment of the validity of SAS [Day 0]
The construct validity will be determined by an exploratory factor analysis and confirmed on an independent sample. Criterion validity will be studied by comparison of scores obtained from SAS to scores obtained from references scale (FIM, WeeFIM, ADL, IADL, BREF, BREV, MMSE and items of WISC IV).
Assessment of the reliability of SAS. [Day 7]
For the inter rater reliability study, patients will be rated on the same day by two groups of therapists. For the test-retest reliability study, patients will be rated twice during their hospitalization, within a time frame sufficiently close so that their dependency should not change.

Secondary Outcome Measures

Study of SAS responsiveness [6 months]
Sensitivity to change will be studied on patients hospitalized in a FRC departments for obesity, spinal cord injuries, post-stroke rehabilitation or cardiorespiratory rehabilitation after cardiac surgery. The change between scores of SAS at entry and exit (or at maximum 6 months after inclusion) of hospitalization will be studied.
Study of invariance of SAS: invariance of the classification between age and sex classes. [day 0]
Invariance of SAS will be determined between three age classes (<18 years, 18-75 years,> 75 years) using three confirmatory factor analyzes

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Centre SSR Les Capucins	Angers	France
2	Etablissement Hopale-Centre Calvé	Berck	France
3	Service SSRS Enfants et Adolescents, Fondation Ildys	Brest	France
4	Médecine physique et réadaptation - Hôpital Raymond Poincaré - APHP	Garche	France
5	Ctre Médico-Chir Réadapt Des Massues	Lyon	France
6	Service de Médecine physique et Réadaptation - Hôpital Henry Gabrielle	Lyon	France
7	Service de Médecine Physique et de Réadaptation - F.Widal - APHP	Paris	France
8	Service de Médecine Physique et Réadaptation - Pôle Couple Mère-Enfant - HOPITAL DE BELLEVUE	Saint-Étienne	France
9	Département de Rééducation Neurologique - Hôpital Sud - CHU de Grenoble	Échirolles	France

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator: Carole VUILLEROT, Hospices Civils de Lyon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT03116204

Other Study ID Numbers:

69HCL17_0027

First Posted:

Apr 14, 2017

Last Update Posted:

Apr 1, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospices Civils de Lyon

Study Results

No Results Posted as of Apr 1, 2020