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:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-24 @ 3:45 PM
NCT ID:
NCT02084992
Eligibility Criteria:
Inclusion Criteria:
1. Patients age ≥ 18 with a primary care provider or specialist that is participating within the Collaborative Health ACO.
2. Patient able to consent
3. A diagnosis of heart failure with at least one of the following risk factors:
* Hospitalization for heart failure within the prior year
* NYHA class III-IV symptoms
* Most recent BNP ≥ 300 pg/mL (or Nt-proBNP ≥ 600 pg/mL) as long as within 90 days prior to enrollment
Exclusion Criteria:
1. Acute myocardial infarction, PCI or CABG within 30 days before enrollment
2. Planned revascularization procedures, cardiac mechanical support implantation, cardiac transplantation, or other cardiac surgery within 30 days following study randomization.
3. Illness other than heart failure deemed the principal limitation to life expectancy or principal cause of disability
4. Severe angina as the principal cause of limitation
5. Uncorrected valvular disease, except where valvular regurgitation was considered to be secondary to severe left ventricular dilation, or where surgical correction is deemed excessively risky or declined by the patient.
6. Moderate to severe dementia such that unable to participate in disease management program
7. Severe visual or auditory disability such that unable to participate in disease management program
8. Hospice care
9. Listed for heart transplantation
10. No access to a working telephone
11. Homeless or no stable home environment
12. Not speaking a language in which the educational documents have been translated
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02084992
Study Brief:
Protocol Section:
NCT02084992