Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT00404027
Eligibility Criteria:
Inclusion Criteria:
Patients enrolled in primary care clinics at the study sites (Iowa City VAMC, Jesse Brown VAMC - Chicago) who are scheduled to be seen by a participating provider in the next three (3) months and have been seen on at least three (3) additional occasions by that same
provider in the prior 24 months. Participating patients must also:
i) have prior diagnoses of both HTN and DM, as documented in VA administrative files;
ii) have an active prescription for an anti-hypertensive medication in the following medication classes: thiazide diuretic, beta blocker, angiotensin converting enzyme (ACE) inhibitor, angiotensin receptor blocker (ARB), calcium channel blocker, or alpha blocker;
iii) have an active prescription for an oral hypoglycemic agent or for an insulin preparation;
iv) be able to provide informed consent;
v) have a home telephone; and
vi) reside in an independent living environment and not in a skilled care facility.
Exclusion Criteria:
i) cognitive impairment;
ii) severe underlying illness, including: metastatic cancer, active treatment for any malignancy (excluding basal and squamous cell skin cancers), end-stage renal disease, cirrhosis, severe chronic obstructive lung disease requiring home oxygen therapy, and congestive
heart failure with a documented left ventricular ejection fraction of less than 35% or a prior echocardiogram denoting "severe" left ventricular dysfunction; and
iii) visits in the prior 18 months to a VA endocrinology, cardiology, or nephrology clinic.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00404027
Study Brief:
Protocol Section:
NCT00404027