Validation of a SOFMER Activity Scale (SAS)
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|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
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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 Type :||Observational|
|Estimated Enrollment :||450 participants|
|Observational Model:||Ecologic or Community|
|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|
|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
- 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).
- 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.
- 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.
- 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
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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|
- 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
- Non-recipient of French Social Security
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
|Contact: Carole VUILLEROT, Ph,D||4 72 12 94 50 ext +firstname.lastname@example.org|
|Contact: Pascal RIPPERT, Ph,D||4 27 85 63 08 ext +email@example.com|
|Centre SSR Les Capucins||Recruiting|
|Contact: Mickaël DINOMAIS, Dr|
|Principal Investigator: Mickaël DINOMAIS, Dr|
|Etablissement Hopale-Centre Calvé||Recruiting|
|Contact: Antoine-Xavier MALLIOPOULOS, Dr|
|Principal Investigator: Antoine-Xavier MALLIOPOULOS, Dr|
|Service SSRS Enfants et Adolescents, Fondation Ildys||Recruiting|
|Contact: Laëtitia HOUX, Dr|
|Principal Investigator: Laëtitia HOUX, Dr|
|Médecine physique et réadaptation - Hôpital Raymond Poincaré - APHP||Recruiting|
|Contact: Philippe AZOUVI, Pr|
|Principal Investigator: Philippe AZOUVI, Pr|
|Ctre Médico-Chir Réadapt Des Massues||Recruiting|
|Contact: Jean-Claude BERNARD, Dr|
|Principal Investigator: Jean-Claude BERNARD, Dr|
|Service de Médecine physique et Réadaptation - Hôpital Henry Gabrielle||Recruiting|
|Contact: Gilles RODE, Pr|
|Principal Investigator: Gilles RODE, Pr|
|Service de Médecine Physique et de Réadaptation - F.Widal - APHP||Recruiting|
|Contact: Alain YELNIK, Pr|
|Principal Investigator: Alain YELNIK, Pr|
|Service de Médecine Physique et Réadaptation - Pôle Couple Mère-Enfant - HOPITAL DE BELLEVUE||Recruiting|
|Contact: Vincent GAUTHERON, Pr|
|Principal Investigator: Vincent GAUTHERON, Pr|
|Département de Rééducation Neurologique - Hôpital Sud - CHU de Grenoble||Recruiting|
|Contact: Dominic PERENNOU, Pr|
|Principal Investigator: Dominic PERENNOU, Pr|
|Principal Investigator:||Carole VUILLEROT||Hospices Civils de Lyon|
|Responsible Party:||Hospices Civils de Lyon|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|