Heart Failure Patient Self-Management Web Portal Pilot Study

The study will be based on a sample of 25 heart failure patients enrolled with the UMHS
Heart Failure Program who give informed consent to participate in the study. The clinical
protocols and electronic software were developed by the UMHS-CVC Heart Failure Program in
collaboration with the UMHS Telemedicine Resource Center. These protocols contain automated
trigger mechanisms when certain values are exceeded to alert the provider and the patient
for the need to take appropriate remedial action.

The UMHS Heart Failure Disease Management Program contains a registry of more than 3000
patients with heart failure problems. Currently, a multidisciplinary nursing team maintains
routine contacts with these patients through telephone calls and paper records. The program
has been acknowledged for its adherence to quality of care measures, and was the first to be
awarded accreditation by JCAHO for ambulatory heart failure care. Despite its relative
success, patients continue to be at high risk for re-hospitalization due to worsened heart
function. The proposed tele-monitoring system is expected to reduce the need for
re-hospitalization and to improve health outcomes by virtue of automated daily reporting and
greater patient involvement in self-management. Because of its high promise, this area of
research has been receiving increased attention, but so far without definitive results.
Previous research has provided evidence of reduced emergency room visits and
hospitalizations, improved patient compliance with care and overall cost containment among
high-risk patient populations. But the studies relied on relatively expensive systems
involving specialized hardware and proprietary software. The cost of these interventions
presents a limitation to the broad adoption and use of the technology. The proposed project
is an attempt to ascertain the optimal method from a clinical and cost standpoint for
in-home telemonitoring for this large patient population that is likely to grow with the
aging of the population.

The primary end-points of this pilot are: (1) patient willingness to use the system,
perceptions regarding its efficacy and effectiveness and problems encountered in its use;
(2) patient adherence to heart failure-specific self care practices; (3) patient health
literacy and quality of life; and (4) provider perceptions of the efficacy and effectiveness
of the system and problems encountered in its use.

The findings should be helpful in refining the clinical protocols and data management
algorithms and establishing a solid foundation for large-scale randomized clinical trials
for obtaining the necessary evidence for wide-scale adoption of these systems in the United
States and elsewhere.

Inclusion Criteria:

- Inclusion criteria

1. Clinical diagnosis of heart failure with NYHA II-IV symptoms, or evidence of
at least one heart failure hospitalization within the past 12 months.

2. Provider permission to approach patient for enrollment

3. Willingness to sign informed consent

Exclusion Criteria:

- Exclusion criteria include patients who are

1. Under the age of 19

2. Asymptomatic heart failure

3. Prisoners

4. Residents of long term nursing facilities

5. Receiving dialysis

6. Serum creatinine ≥ 3.5 mg/dL

7. Candidates for revascularization

8. Candidates for valve replacement or repair

9. With comorbidity (i.e. metastatic cancer) that is likely to lead to
rehospitalization or death within a 12 month period

10. Due to a reversible cause (i.e. hypothyroidism, anemia, etc)

11. With pulmonary arterial hypertension that is not due to left ventricular
dysfunction.

12. Pregnant women or women of child bearing potential who are actively attempting
to become pregnant or are not using an accepted form of contraception