Telehealth Management in HF Disparity Patients

NCT02196922 | Completed Results

• 1 other identifier: NCT02196922
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Heart Failure

Keywords

Chronic Heart Failure; Telehealth; Self Management

Outcome Measures

Primary Outcomes (2)

• Hospitalizations

  Number of hospitalizations during the 90 day observation period

  Baseline and Day 90

• Emergency Department Visits

  Emergency Department Visits, defined as Mean Number of visits over the 90 day observation period

  Days 0-90

Secondary Outcomes (1)

• Quality of Life

  Baseline and Day 90

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Patients in the control group will receive standard of care at a Heart Failure clinic (primary and cardiac care as reimbursed by Medicare or sliding scale/uncompensated care). Standard of care patients will be contacted on a weekly basis in order to maintain comparable frequency of contact.

Other: Standard of Care

Telehealth Self Management (TSM)

EXPERIMENTAL

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.

Device: Telehealth Self Management (TSM)

Interventions

Telehealth Self Management (TSM) DEVICE

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.

Telehealth Self Management (TSM)

Standard of Care OTHER

Patients receiving standard of care experience typical chronic care management received by Medicare patients.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Nassau University Medical Center

East Meadow, New York, 11554, United States

Location

Related Publications (1)

• Pekmezaris R, Schwartz RM, Taylor TN, DiMarzio P, Nouryan CN, Murray L, McKenzie G, Ahern D, Castillo S, Pecinka K, Bauer L, Orona T, Makaryus AN. A qualitative analysis to optimize a telemonitoring intervention for heart failure patients from disparity communities. BMC Med Inform Decis Mak. 2016 Jun 24;16:75. doi: 10.1186/s12911-016-0300-9.

  PMID: 27343060 DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Renee Pekmezaris, Ph.D., Vice President Community Health & Health Services Research
• Organization: Northwell Health

rpekmeza@northwell.edu

516 465-3161

Study Officials

• Renee Pekmezaris, PhD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: July 18, 2014
• First Posted: July 22, 2014
• Study Start: January 1, 2014
• Primary Completion: April 30, 2017
• Study Completion: April 30, 2017
• Last Updated: November 17, 2017
• Results First Posted: November 17, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)