Observatory on Elderly Patients "Les S.AGES"

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Chronic Pain Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sanofi-Aventis Administrative Office

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

National Observatory on the Therapeutic Management in Ambulatory Care Patients Aged 65 and Over, With Diabetes Type 2, Chronic Pain or Atrial Fibrillation

Important dates

Study start: 2009
Primary completion: 2014
Study completion: 2014
First posted: Feb 9, 2010
Registry last updated: Oct 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed