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Trial record 1 of 1 for:    NCT02196922
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Telehealth Management in HF Disparity Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02196922
Recruitment Status : Completed
First Posted : July 22, 2014
Results First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Information provided by (Responsible Party):
Renee Pekmezaris, Northwell Health

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.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Device: Telehealth Self Management (TSM) Other: Standard of Care Not Applicable

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 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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open label
Primary Purpose: Prevention
Official Title: Telehealth Self-Management Program in Older Adults Living With Heart Failure in Health Disparity Communities
Study Start Date : January 1, 2014
Actual Primary Completion Date : April 30, 2017
Actual Study Completion Date : April 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Hospitalizations [ Time Frame: Baseline and Day 90 ]
    Number of hospitalizations during the 90 day observation period

  2. Emergency Department Visits [ Time Frame: Days 0-90 ]
    Emergency Department Visits, defined as Mean Number of visits over the 90 day observation period

Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: Baseline and Day 90 ]
    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)

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02196922

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United States, New York
Nassau University Medical Center
East Meadow, New York, United States, 11554
Sponsors and Collaborators
Northwell Health
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Principal Investigator: Renee Pekmezaris, PhD Northwell Health
  Study Documents (Full-Text)

Documents provided by Renee Pekmezaris, Northwell Health:
Study Protocol  [PDF] March 25, 2016
Statistical Analysis Plan  [PDF] March 25, 2016

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Renee Pekmezaris, principal investigator, Northwell Health Identifier: NCT02196922    
First Posted: July 22, 2014    Key Record Dates
Results First Posted: November 17, 2017
Last Update Posted: November 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Renee Pekmezaris, Northwell Health:
Chronic Heart Failure
Self Management
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases