Clinical trial NCT01065909: Observatory on Elderly Patients "Les S.AGES"
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Chronic Pain
Atrial Fibrillation
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-02-09
Enrollment: 3491
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ambulatory primary care patient over 65 years

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


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Zitoun S, Baudouin E, Corruble E, Vidal JS, Becquemont L, Duron E. Use of potentially driver-impairing drugs among older drivers. BMC Geriatr. 2022 Jan 3;22(1):4. doi: 10.1186/s12877-021-02726-5.
citation: Hanon O, Vidal JS, Pisica-Donose G, Benattar-Zibi L, Bertin P, Berrut G, Corruble E, Derumeaux G, Falissard B, Forette F, Pasquier F, Pinget M, Ourabah R, Becquemont L, Danchin N; S.AGES Investigators. Therapeutic management in ambulatory elderly patients with atrial fibrillation: the S.AGES cohort. J Nutr Health Aging. 2015 Feb;19(2):219-27. doi: 10.1007/s12603-015-0444-9.
citation: Bucher S, Bauduceau B, Benattar-Zibi L, Bertin P, Berrut G, Corruble E, Danchin N, Delespierre T, Derumeaux G, Doucet J, Falissard B, Forette F, Hanon O, Ourabah R, Pasquier F, Piedvache C, Pinget M, Ringa V, Becquemont L; S.AGES Investigators. Primary care management of non-institutionalized elderly diabetic patients: The S.AGES cohort - Baseline data. Prim Care Diabetes. 2015 Aug;9(4):267-74. doi: 10.1016/j.pcd.2014.07.004. Epub 2014 Jul 31.
citation: Bertin P, Becquemont L, Corruble E, Derumeaux G, Falissard B, Hanon O, Pinget M, Forette F. The therapeutic management of chronic pain in ambulatory care patients aged 65 and over in France: the S.AGES Cohort. Baseline data. J Nutr Health Aging. 2013;17(8):681-6. doi: 10.1007/s12603-013-0338-7.