Please select the eligibility criteria that correspond to the clinical trial below.
Title: Community Health Worker Support to Help Patients Control Chronic Disease
Brief Summary: The purpose of this proposal is to compare the effectiveness of community health worker (CHW) support vs. usual primary care for helping chronically-ill, low-SES patients to improve control of chronic conditions. Upon enrollment each patient will select one of their multiple chronic conditions as a focus for the trial and work with his/her PCP to set a chronic disease management goal. Patients are then randomized to receive usual primary care vs. CHW support for moving towards that goal.


Options:
A: Inclusion Criteria:

* Filled and poorly adherent (defined as a PDC \< 80%) to medication for hyperlipidemia, hypertension, or diabetes
* Suboptimal average adherence to all of the qualifying medications that a patient has filled (defined as combined (average of averages) PDC \< 80%)
* For patients with hypertension or diabetes, poor or worsening disease control (according to relevant clinical targets)

Exclusion Criteria:

* Patients with \<6 months of continuous enrolment in the health plan
* Patients with no available contact information
B: Inclusion Criteria:

* diabetic, at least 18 years old, patient at a participating health clinic
C: Inclusion Criteria:

* Patient of target practices for at least 1 yr defined as having one office visit within preceding 12 month
* Home ZIP code including ANY of the following: 1. 19104 2. 19131 3. 19139 4. 19143 5. 19146
* 2 or more of the following conditions: 1. Obesity (BMI greater than 30), 2. HTN (ICD9 relating to HTN in EMR), 3. DM (ICD9 relating to DM in EMR), 4. Asthma/COPD and tobacco dependence (ICD9 for asthma or COPD in EMR AND documentation of tobacco use)
* Uninsured, insured by Medicaid or dually eligible for Medicaid/Managed Medicare
* Patients who have scheduled appointments in the future.

Exclusion Criteria:

* Will not provide informed consent for this study.
* Does not have the capacity to provide informed consent for this study.
* Previously enrolled in this study
D: Inclusion criteria:

* Diagnosis of type 2 Diabetes Mellitus
* Patients treated with combined oral antidiabetic drugs(as fixed combination or simultaneous administration) or with metformin in monotherapy at maximal doses for at least 3 months
* Patients having BMI \> 25 Kg/m2;
* Patients having a HbA1c ≥ 7.5 % and ≤ 11 %
* Female patients must be menopausal, surgically sterile, or using effective contraceptive measures;
* Female of childbearing potential must use effective contraceptive measures for at least 1 month prior to the entry into the study and should continue to use the same contraceptive method during the overall study period.

Exclusion criteria:

* Patients diagnosed with type 1 insulin dependent Diabetes Mellitus;
* History of two or more severe hypoglycaemic episodes within the past 3 months or history of unawareness hypoglycaemia;
* Active proliferative diabetic retinopathy, as defined by the application of focal or panretinal photocoagulation or vitrectomy, in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require surgical treatment (including laser photocoagulation);
* Impaired renal function
* Impaired liver function
* History of hypersensitivity to insulin or insulin analogues or any of the excipients in the Insulin glulisine and Insulin glargine formulation
* History of hypersensitivity to metformin;
* Pregnant or breast-feeding women, or women planning to become pregnant during the study;
* Failure to use adequate contraception (women of current reproductive potential only);
* Any clinically significant major organ system disease such as relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, haematological or other major systemic diseases or infective diseases;
* History of drug or alcohol abuse within the last 2 years or current addiction to substances of abuse;
* Night shift workers;
* Receipt of an experimental drug or use of an experimental device within the 30 days prior to study entry;
* Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study;
* Treatment or likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol;
* Any disease or condition including abuse of illicit drugs, prescription medicines or alcohol that in the opinion of the investigator or sponsor may interfere with the completion of the study;
* Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study procedures;
* Subject is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol;
* Previous enrolment in the present study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Answer: C