Telehealth Management in HF Disparity Patients

Chronic Heart Failure Clinical Trial

Official title:

Telehealth Self-Management Program in Older Adults Living With Heart Failure in Health Disparity Communities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02196922
• Other study ID #: NCT02196922
• Status: Completed
• Phase: N/A
• First received: July 18, 2014
• Last updated: October 18, 2017
• Start date: January 1, 2014
• Est. completion date: April 30, 2017

Study information

• Verified date: October 2017
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: April 30, 2017
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic Heart Failure (CHF) patients about to be discharged from Nassau University Medical Center (NUMC)

• 18 years and older

• New York Heart Association (NYHA) class of 1-3

• Primary language of Spanish or English

• Access to a phone (land line or cell),

• Folstein Mini Mental Status Exam (MMSE) score of 21 or higher.

Exclusion Criteria:

• Patients with heart failure NYHA class 4

• Patients under age 18

• Anyone with a primary language that is not English or Spanish

• Anyone with a Folstein MMSE score under 21 (indicative of cognitive impairment)

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Device:
• Telehealth Self Management (TSM)
Experimental: Telehealth Self Management (TSM) TSM is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence, via a standard telephone line to the provider station.

Other:
• Standard of Care
Patients receiving standard of care experience typical chronic care management received by Medicare patients.

Locations

Country	Name	City	State
United States	Nassau University Medical Center	East Meadow	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalizations	Number of hospitalizations during the 90 day observation period	Baseline and Day 90
Primary	Emergency Department Visits	Emergency Department Visits, defined as Mean Number of visits over the 90 day observation period	Days 0-90
Secondary	Quality of Life	Minnesota Quality of Life Questionnaire is a validated instrument specifically designed to measure quality of life for heart failure patients. Possible scores range from 0 (best quality of life) to 105 (worst quality of life)	Baseline and Day 90