ITMO public health
Last update : 09/05/2017 | Version : 2 | ID : 2845
| General | |
| Identification | |
| Detailed name | Multidisciplinary care of the metabolic syndrome during spa therapy |
| Sign or acronym | PRISM |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CCTI-RS 08.076bis, CNIL 908160 |
| General Aspects | |
| Medical area |
Endocrinology and metabolism |
| Health determinants |
Lifestyle and behavior Medicine Nutrition |
| Keywords | Metabolic syndrome, spa therapy, multidisciplinary care, balneology, department of pharmacology, pharmacoepidemiology, cohort, Bordeaux |
| Scientific investigator(s) (Contact) | |
| Name of the director | Moore |
| Surname | Nicholas |
| Address | Bât du Tondu - Case 41 - 146, Rue Léo Saignat - 33076 BORDEAUX Cedex |
| Phone | + 33 (0)5 57 57 46 75 |
| nicholas.moore@u-bordeaux.fr | |
| Unit | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Organization | Université Bordeaux |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | Association Française pour la Recherche Thermale - AFRETh (soutien inconditionnel) dans le cadre de l’Appel d’Offre 2007 |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Longitudinal study (except cohorts) |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is is made on the basis of: |
Another treatment or procedure |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | 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. |
| Database objective | |
| Main objective | 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. |
| Inclusion criteria | 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. |
| Population type | |
| 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 covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | Patients initiating spa therapy at Eugénie les Bains |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2008 |
| Date of last collection (YYYY or MM/YYYY) | 2009 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 145 patients inclus dont 97 patients suivis pendant 1 an |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Administrative data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Paper self-questionnaire Face to face interview Phone interview |
| Administrative data (detail) | Name, first name, home address, email address, phone number, general practitioner address |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception Others |
| Care consumption (detail) |
Medical/paramedical consultation Medicines consumption |
| Other (detail) | Dietary evaluation (questionnaire Nutrition Alimentation) |
| Procedures | |
| Data collection method | 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. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | 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). |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/Pubmed-PRISME |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | 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. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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