Observatory on Elderly Patients "Les S.AGES"

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01065909
First received: February 8, 2010
Last updated: October 9, 2013
Last verified: October 2013
  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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01065909

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

No publications provided by Sanofi

Additional 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
Study First Received: February 8, 2010
Last Updated: October 9, 2013
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 April 22, 2014