ITMO Santé Publique
ITMO Santé Publique
Date de modification : 05/09/2017 | Version : 2 | ID : 2845
| Général | |
| Identification | |
| Nom détaillé | Multidisciplinary care of the metabolic syndrome during spa therapy |
| Sigle ou acronyme | PRISM |
| Numéro d'enregistrement (ID-RCB ou EUDRACT, CNIL, CPP, etc.) | CCTI-RS 08.076bis, CNIL 908160 |
| Thématiques générales | |
| Domaine médical |
Endocrinology and metabolism |
| Déterminants de santé |
Lifestyle and behavior Medicine Nutrition |
| Mots-clés | Metabolic syndrome, spa therapy, multidisciplinary care, balneology, department of pharmacology, pharmacoepidemiology, cohort, Bordeaux |
| Responsable(s) scientifique(s) | |
| Nom du responsable | Moore |
| Prénom | Nicholas |
| Adresse | Bât du Tondu - Case 41 - 146, Rue Léo Saignat - 33076 BORDEAUX Cedex |
| Téléphone | + 33 (0)5 57 57 46 75 |
| nicholas.moore@u-bordeaux.fr | |
| Laboratoire | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Organisme | Université Bordeaux |
| Collaborations | |
| Financements | |
| Financements |
Mixed |
| Précisions | Association Française pour la Recherche Thermale - AFRETh (soutien inconditionnel) dans le cadre de l’Appel d’Offre 2007 |
| Gouvernance de la base de données | |
| Organisation(s) responsable(s) ou promoteur | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Statut de l’organisation |
Secteur Public |
| Contact(s) supplémentaire(s) | |
| Caractéristiques | |
| Type de base de données | |
| Type de base de données |
Study databases |
| Base de données issues d'enquêtes, précisions |
Longitudinal study (except cohorts) |
| Origine du recrutement des participants |
A selection of health institutions and services |
| Critère de sélection des participants |
Another treatment or procedure |
| Le recrutement dans la base de données s'effectue dans le cadre d'une étude interventionnelle |
No |
| Informations complémentaires concernant la constitution de l'échantillon | Spa physicians proposed the study to non-diabetic patients initiating spa therapy between July 2008 and December 2009 and presenting with metabolic syndrome. Patients fulfilling the inclusion criteria and agreeing to participate were included. Those whose general practitioner agreed to participate were followed for 1 year without any further intervention. |
| Objectif de la base de données | |
| Objectif principal | The main objective of this study was to determine the maximal effect of multidisciplinary management initiated during spa therapy on metabolic syndrome at one year. |
| Critères d'inclusion | Patient presenting a metabolic syndrome according to the criteria of the NCEP-ATP III (at least three of the following criteria: waist circumference > 102 cm for men and 88 cm for women, triglycerides ≥ 1.5 g/l, HDL-Cholestérol < 0.4 g/l for men and 0.5 g/l for women, fasting glycaemia ≥ 1.10 g/l, blood pressure ≥ 130/85 mmHg 130/85); greater than 18 years old; patient having a BMI < 40; patient having a fasting glycaemia < 1.26 g/l; patient who can be followed during the study period; patient able to understand the protocol and complete the questionnaire; patient initiating spa therapy for "metabolic disease" (alone or with a second indication); patient accepting to participate in the study. |
| Type de population | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population concernée |
Sick population |
| Sexe |
Male Woman |
| Champ géographique |
National |
| Détail du champ géographique | Patients initiating spa therapy at Eugénie les Bains |
| Collecte | |
| Dates | |
| Année du premier recueil | 2008 |
| Année du dernier recueil | 2009 |
| Taille de la base de données | |
| Taille de la base de données (en nombre d'individus) |
< 500 individuals |
| Détail du nombre d'individus | 145 patients inclus dont 97 patients suivis pendant 1 an |
| Données | |
| Activité de la base |
Data collection completed |
| Type de données recueillies |
Clinical data Declarative data Administrative data |
| Données cliniques, précisions |
Direct physical measures Medical registration |
| Données déclaratives, précisions |
Paper self-questionnaire Face to face interview Phone interview |
| Données administratives, précisions | Name, first name, home address, email address, phone number, general practitioner address |
| Existence d’une biothèque |
No |
| Paramètres de santé étudiés |
Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception Others |
| Consommation de soins, précisions |
Medical/paramedical consultation Medicines consumption |
| Autres, précisions | Dietary evaluation (questionnaire Nutrition Alimentation) |
| Modalités | |
| Mode de recueil des données | The inclusion data were collected by the thermal team (thermal physician, dietician, psychologist) and from the patient (paper questionnaire). During the follow-up at 6 and 12 months, the data were collected by the coordinating centre from the patients and their general practitioners. |
| Suivi des participants |
Yes |
| Détail du suivi | The patients included by the thermal physicians were also seen by a dietician and a nurse to fill-out two questionnaires. They participated in multidisciplinary care programme associated with the hydrotherapy. Those whose general practitioner agreed to participate were contacted again at 6 and 12 months to complete a telephone questionnaire (SF36 quality of life evaluation, physical activity, perceived health status, dietary evaluation). In parallel, general practitioners were also contacted at 6 and 12 months to fill-out a medical questionnaire (vital status, clinical examination, cardiovascular events, biological examinations and medicinal treatments). |
| Appariement avec des sources administratives |
No |
| Valorisation et accès | |
| Valorisation et accès | |
| Lien vers le document | http://tinyurl.com/Pubmed-PRISME |
| Description | List of publications in Pubmed |
| Accès | |
| Charte d'accès aux données (convention de mise à disposition, format de données et délais de mise à disposition) | A study report was delivered to the AFRETh after validation by the study Steering committee experts. Ownership of study data is the subject of an agreement between the University of Bordeaux Segalen and the AFRETh. Terms for third-party access to the database are to be defined. |
| Accès aux données agrégées |
Access on specific project only |
| Accès aux données individuelles |
Access on specific project only |
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