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: July 17, 2014
Last verified: July 2014
  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: July 2014
Estimated Primary Completion Date: July 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 17, 2014
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 July 29, 2014