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Validation of a SOFMER Activity Scale (SAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03116204
Recruitment Status : Unknown
Verified March 2020 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : April 14, 2017
Last Update Posted : April 1, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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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
Patients Hospitalized in a FRC Department Other: Assessment of score SAS

Study Design
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Study Type : Observational
Estimated 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 : November 21, 2018
Estimated Primary Completion Date : May 21, 2020
Estimated Study Completion Date : May 21, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Assessment of the validity of SAS [ Time Frame: 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).


  2. Assessment of the reliability of SAS. [ Time Frame: 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 :
  1. Study of SAS responsiveness [ Time Frame: 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.

  2. Study of invariance of SAS: invariance of the classification between age and sex classes. [ Time Frame: 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
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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients hospitalized in a FRC department
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03116204


Contacts
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Contact: Carole VUILLEROT, Ph,D 4 72 12 94 50 ext +33 carole.vuillerot@chu-lyon.fr
Contact: Pascal RIPPERT, Ph,D 4 27 85 63 08 ext +33 pascal.rippert@chu-lyon.fr

Locations
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France
Centre SSR Les Capucins Recruiting
Angers, France
Contact: Mickaël DINOMAIS, Dr         
Principal Investigator: Mickaël DINOMAIS, Dr         
Etablissement Hopale-Centre Calvé Recruiting
Berck, France
Contact: Antoine-Xavier MALLIOPOULOS, Dr         
Principal Investigator: Antoine-Xavier MALLIOPOULOS, Dr         
Service SSRS Enfants et Adolescents, Fondation Ildys Recruiting
Brest, France
Contact: Laëtitia HOUX, Dr         
Principal Investigator: Laëtitia HOUX, Dr         
Médecine physique et réadaptation - Hôpital Raymond Poincaré - APHP Recruiting
Garche, France
Contact: Philippe AZOUVI, Pr         
Principal Investigator: Philippe AZOUVI, Pr         
Ctre Médico-Chir Réadapt Des Massues Recruiting
Lyon, France
Contact: Jean-Claude BERNARD, Dr         
Principal Investigator: Jean-Claude BERNARD, Dr         
Service de Médecine physique et Réadaptation - Hôpital Henry Gabrielle Recruiting
Lyon, France
Contact: Gilles RODE, Pr         
Principal Investigator: Gilles RODE, Pr         
Service de Médecine Physique et de Réadaptation - F.Widal - APHP Recruiting
Paris, France
Contact: Alain YELNIK, Pr         
Principal Investigator: Alain YELNIK, Pr         
Service de Médecine Physique et Réadaptation - Pôle Couple Mère-Enfant - HOPITAL DE BELLEVUE Recruiting
Saint-Étienne, France
Contact: Vincent GAUTHERON, Pr         
Principal Investigator: Vincent GAUTHERON, Pr         
Département de Rééducation Neurologique - Hôpital Sud - CHU de Grenoble Recruiting
Échirolles, France
Contact: Dominic PERENNOU, Pr         
Principal Investigator: Dominic PERENNOU, Pr         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Carole VUILLEROT Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03116204    
Other Study ID Numbers: 69HCL17_0027
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Dependency
FRC department
scale validation
validity
reliability