Please select the eligibility criteria that correspond to the clinical trial below.
Title: Clinical Evaluation to Assess the Effect of the Combination of a Pre-Defined Management Pathway to Reduce Fluid Overload in Cardiac Decompensation With Carelink Remote Management, Connexus Remote Telemetry and the OptiVol Early Warning System on Health Care Utilization
Brief Summary: This pilot study is to prospectively evaluate the benefit of clinicians being able to access ICD device information in a timelier manner and treat fluid overload with a pre-defined pattern using the Medtronic OptiVol, Medtronic CareAlerts and Medtronic CareLink in Conexus-enabled devices (remote arm) as compared to the same devices without Medtronic OptiVol, Medtronic CareAlerts and Medtronic CareLink available to the treating physician (standard arm).


Options:
A: Inclusion Criteria:

* Hypertension, hypercholesterolemia, and/or diabetes mellitus, all of which are treated with medication, measured in the clinic, or confirmed by primary care provider (systolic blood pressure greater than or equal to 140 mm Hg, diastolic blood pressure greater than or equal to 90 mm Hg, low density lipoprotein cholesterol \[LDL-C\] greater than or equal to 130 mg/dL, or fasting blood sugar greater than 125 mg/dL)
* BMI of at least 30 to 50 kg/m2 and weight less than or equal to 400 lbs
* Willing to change diet, physical activity, and weight
* Willing to be randomly assigned to any of the study groups
* Patient of a participating doctor
* Patient self-reports two doctor visits in the 12 months before study entry
* Demonstrated use of Web and e-mail
* Access to Internet at least 4 days per week
* People with the following conditions are eligible to enroll in the study with primary care provider approval:

  1. Diabetes mellitus
  2. Prior cardiovascular disease event more than 6 months before study entry
  3. Known stable cardiovascular disease or peripheral vascular disease
  4. Screen positive on Rose Questionnaire

Exclusion Criteria:

* Heart attack, stroke, or atherosclerotic cardiovascular disease (ASCVD) procedure in the 6 months before study entry
* Serious medical condition that is likely to hinder accurate measurement of weight, for which weight loss is not advisable, or that would cause weight loss \[e.g., end-stage renal disease (ESRD) on dialysis, cancer diagnosis or treatment in the 2 years before study entry\]
* Prior or planned bariatric surgery
* Use of prescription weight loss medication, including off-label drugs (e.g., topiramate, bupropion, byetta) or over-the-counter orlistat in the 6 months before study entry
* Long-term use (in the 6 months before study entry) of medications likely to cause weight gain or prevent weight loss (e.g., corticosteroids, lithium, olanzapine, risperidone, clozapine)
* Unintentional weight loss in the 6 months before study entry (greater than or equal to 5% of body weight)
* Intentional weight loss in the 6 months before study entry (greater than or equal to 5% of body weight)
* Pregnant or breastfeeding in the 6 months before study entry
* Planning to become pregnant in the 2 years after study entry
* Planning to relocate from area in the 2 years after study entry
* Another member of the household is a study participant or study staff member
* Self-reported average consumption of more than 14 alcoholic drinks each week
* Psychiatric hospitalization in the 1 year before study entry
* Unstable angina
* Blood pressure greater than 160/100 mm Hg
B: Inclusion Criteria:

* Type 1 diabetes under care of Joslin Diabetes Center in Syracuse NY
* Grade K-8
* Age 5-14 at time of enrollment
* Consent of student, parent and school
C: Inclusion Criteria:

* Implantation of a market-approved Medtronic Connexus CRT-D- or DR-ICD-device
* Patient consents to study
* Ability to replace follow-ups with CareLink follow-ups
* Ability to attend all follow-ups at study center

Exclusion Criteria:

* Permanent AF
* Less than 18 years of age
* Life expectancy less than 15 months
* Participation in another clinical study
* Pregnancy
D: Inclusion Criteria:

* Current or former smokers with a diagnosis of COPD
* Having impaired lung function as measured by spirometry

Exclusion Criteria:

* History of asthma or nasal symptoms caused by hayfever
* No telephone
* Inability to record symptoms in an electronic diary (PDA)

Answer: C