Observatory on Elderly Patients "Les S.AGES"
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Purpose
Primary objective shared by the 3 registries : Describe the different pharmacotherapeutic management in patients :
- DB (Diabetes): with type 2 diabetes, treated with oral and / or injectable antidiabetics
- CP (Chronic Pain): with any disease leading to chronic pain (lasting for more than 3 months)
- AF (Atrial Fibrillation): with ongoing AF or AF diagnosed within 12 months before enrollment
Secondary objectives shared by the 3 observatories:
- Describe the occurrence of clinical events, hospitalizations and death, according to the different medical care conditions, and analyze their predicting factors
- Estimate the resources consumption according to the medical and non medical management of these patients,
- Analyze the impact of some factors (patient's cognitive status, autonomy, renal function ...) on the current practice
Secondary objectives specific shared by DB and AF registries :
- Analyze the geriatric pharmaco-genetic aspects
Specific secondary objectives for each observatory :
- DB : Describe HbA1c level, percentage of responders and body weight evolution according to the different medical care conditions
- CP : Evaluate pain consequences on Daily Living Activities and patient autonomy
| Condition |
|---|
|
Diabetes Mellitus, Type 2 Chronic Pain Atrial Fibrillation |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | National Observatory on the Therapeutic Management in Ambulatory Care Patients Aged 65 and Over, With Diabetes Type 2, Chronic Pain or Atrial Fibrillation |
| Estimated Enrollment: | 4500 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Diabetes type 2 |
| Chronic Pain |
| Atrial Fibrillation |
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Ambulatory primary care patient over 65 years
Inclusion Criteria specific for each observatory :
- DB : Established type 2 diabetes treated with oral and / or injectable antidiabetics
- CP : Pain lasting for over 3 months, requiring therapeutic care
- FA : Ongoing Atrial fibrillation or AF diagnosed within the 12 months before enrollment and documented by ECG or Holter ECG, whatever the rhythm at inclusion
Exclusion Criteria shared by the 3 observatories:
- Living in accommodation facility for dependent patients
- Patient with non cardiovascular progressively unstable disease
- Patient already enrolled in a clinical trial
- Patient unlikely to complete the study
Exclusion Criteria specific for just AF observatory :
- Transitional AF due to thyrotoxicosis, alcohol, myocarditis, pericarditis, acute myocardial infarction, pulmonary embolism, metabolic disorders or electrocution, Post cardiac surgery AF (<3 months).
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01065909 History of Changes |
| Other Study ID Numbers: | DIREG_L_04182 |
| Study First Received: | February 8, 2010 |
| Last Updated: | January 9, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Atrial Fibrillation Diabetes Mellitus Diabetes Mellitus, Type 2 Arrhythmias, Cardiac Heart Diseases |
Cardiovascular Diseases Pathologic Processes Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013