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Observatory on Elderly Patients "Les S.AGES"

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ClinicalTrials.gov Identifier: NCT01065909
Recruitment Status : Completed
First Posted : February 9, 2010
Last Update Posted : October 3, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease
Diabetes Mellitus, Type 2 Chronic Pain Atrial Fibrillation

Study Design

Study Type : Observational
Actual Enrollment : 3491 participants
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
Study Start Date : May 2009
Primary Completion Date : September 2014
Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Diabetes type 2
Chronic Pain
Atrial Fibrillation


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Ambulatory primary care patient over 65 years
Criteria

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

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): NCT01065909


Locations
France
Sanofi-Aventis Administrative Office
Paris, France
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01065909     History of Changes
Other Study ID Numbers: DIREG_L_04182
First Posted: February 9, 2010    Key Record Dates
Last Update Posted: October 3, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Atrial Fibrillation
Diabetes Mellitus, Type 2
Chronic Pain
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms