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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by North Shore Long Island Jewish Health System
Sponsor:
Information provided by (Responsible Party):
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT02196922
First received: July 18, 2014
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Chronic Heart Failure
Device: Telehealth Self Management (TSM)
Other: Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Telehealth Self-Management Program in Older Adults Living With Heart Failure in Health Disparity Communities

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • Hospital utilization [ Time Frame: Days 1-90 Post-hospitalization ] [ Designated as safety issue: No ]
    ER and inpatient utilization


Secondary Outcome Measures:
  • Quality of Life [ Time Frame: Day 1- Day90 ] [ Designated as safety issue: Yes ]
    Minnesota Quality of Life Questionnaire for CHF Patients


Estimated Enrollment: 104
Study Start Date: January 2014
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard of Care
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
Patients receiving standard of care experience typical chronic care management received by Medicare patients.
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.
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.

Detailed 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 room (ER) 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 ER 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 ER burden. Chronic disease self-management programs have the potential to reduce health care costs while improving patient health status, particularly for medically underserved communities.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CHF patients about to be discharged from NUMC
  • 18 years and older
  • NYHA class of 1-3
  • Primary language of Spanish or English
  • Access to a phone (land line or cell),
  • Folstein 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02196922

Contacts
Contact: Renee Pekmezaris, PhD 516 465-3161 rpekmeza@nshs.edu
Contact: Paola DiMarzio, PhD 516 465-3167 pdimarzi@nshs.edu

Locations
United States, New York
Nassau University Medical Center Recruiting
East Meadow, New York, United States, 11554
Principal Investigator: Renee Pekmezaris, PhD         
Sub-Investigator: Paola DiMarzio, PhD         
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Renee Pekmezaris, PhD North Shore-LIJ Health System
  More Information

No publications provided

Responsible Party: North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT02196922     History of Changes
Other Study ID Numbers: Telehealth CHF Disparities
Study First Received: July 18, 2014
Last Updated: July 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
Chronic Heart Failure
Telehealth
Self Management

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014