Chronic Heart Failure Clinical Trial
Official title:
Telehealth Self-Management Program in Older Adults Living With Heart Failure in Health Disparity Communities
In the US, racial and ethnic disparities persist, even when income, health insurance and care
access are addressed. For example, there is a greater prevalence of chronic heart failure
(CHF), higher rates of hospital use and higher death rates in blacks as compared to whites.
This is due to many factors including: reduced healthcare access, higher prevalence of
hypertension,coronary artery disease, systolic dysfunction, myocardial infarction and
obesity. Given the magnitude of this chronic health issue, the growth of the elderly
population, and increases in ethnic diversity, providers need to develop new ways of caring
for those with chronic conditions living in health disparity communities.
The investigators propose to implement a randomized study with health disparity
community-dwelling patients. A bilingual clinician will follow patients for 3 months after
hospitalization for CHF to test this approach for the proposed health disparity population.
The investigators will obtain patient/caregiver input at multiple points during the research
to make necessary adjustments to the intervention to ensure that disparity patients
accept/use the system, and are satisfied. To ensure that proposed outcomes have relevance for
patients, a Community Advisory Board (CAB) of stakeholders will advise the study team
throughout the study process. The investigators believe that studying patient use of TSM over
a 3 month period will: 1) identify cost-effective care approaches for patients living with
chronic disease; 2) involve the patient in identifying and testing approaches that work for
them; 3) enhance provider-patient communication; 4) teach the patient how to self-monitor and
explore his/her role in self-care; 5) improve patient education about treatment options and
6) explore how "usable" the patients feel the program is. If our goals are achieved, these
strategies will result in patient-led improvements in health, satisfaction and quality of
life. Knowledge gained will further understanding of the use of telehealth programs as
effective self-management tools.
Disparities in cardiovascular disease have received particular focus, as cardiovascular
disease is a major contributor to differences in morbidity and mortality between blacks and
whites. African Americans, for example, are hospitalized for chronic heart failure (CHF) at a
higher rate than whites and are 30% more likely to die from CHF than white individuals.
Community-dwelling patients with CHF typically receive exacerbation-focused care, leading to
high rates of emergency department (ED) and hospital utilization. The lack of comprehensive
chronic disease management leads to poor patient outcomes, and increased health care costs.
Given the larger burden of CHF and the unfavorable disease outcomes in disparity communities,
a tailored and more focused management of this clinical condition is warranted.
We propose to:
1. Assess telehealth self management (TSM) usability, utilizing a mixed-methods approach,
focusing on patient and stakeholder input, with the goal of adapting the intervention to
facilitate acceptability and feasibility in a population of low-income ethnic minority
patients. Prior to intervention implementation, we will determine characteristics of the
intervention requiring adaptation to maximize usability through focus groups, with key
community stakeholders, patients and caregivers. We will continue the qualitative
usability assessment during the intervention with patients enrolled in the study to
identify barriers/challenges to usability, to further adapt the intervention. Finally,
we will use quantitative methods to assess usability. These quantitative indicators will
also be used to make adjustments and inform future wide-scale interventions that will be
conducted in this community.
2. Compare hospital utilization of low income ethnic minority patients receiving telehealth
technology vs. demographically matched patients receiving standard of care. A randomized
controlled clinical trial will be conducted to test the primary hypothesis that health
care utilization will be lower in the in the TSM group than the usual-care group. We
will specifically compare acute care and ED utilization and quality of life (Minnesota
QoL Questionnaire) between groups. We will adjust for potential confounders
(demographic, clinical, educational and functional/support variables). The target
population is community-dwelling CHF patients discharged home from the Nassau University
Medical Center.
This research will further our understanding of the use of TSM in the management of CHF for
low income, ethnic minority seniors. The proposed research will improve patient outcomes
while reducing unnecessary hospitalizations and ED burden. Chronic disease self-management
programs have the potential to reduce health care costs while improving patient health
status, particularly for medically underserved communities.
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