Observatory on Elderly Patients "Les S.AGES"

Sanofi

Status: Completed

Conditions: Atrial Fibrillation; Chronic Pain; Diabetes Mellitus, Type 2

Study type: Observational

Funder types: Industry

Identifiers

NCT01065909

DIREG_L_04182

Details and patient eligibility

About

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

Enrollment: 3,491 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

3,491 participants in 3 patient groups

Diabetes type 2

Chronic Pain

Atrial Fibrillation