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Telehealth Management in HF Disparity Patients

Primary Purpose

Chronic Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telehealth Self Management (TSM)
Standard of Care
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Heart Failure focused on measuring Chronic Heart Failure, Telehealth, Self Management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Nassau University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care

Telehealth Self Management (TSM)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Full Information

First Posted
July 18, 2014
Last Updated
October 18, 2017
Sponsor
Northwell Health
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1. Study Identification

Unique Protocol Identification Number
NCT02196922
Brief Title
Telehealth Management in HF Disparity Patients
Official Title
Telehealth Self-Management Program in Older Adults Living With Heart Failure in Health Disparity Communities
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2014 (undefined)
Primary Completion Date
April 30, 2017 (Actual)
Study Completion Date
April 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
Chronic Heart Failure, Telehealth, Self Management

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Open label
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Telehealth Self Management (TSM)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Telehealth Self Management (TSM)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Patients receiving standard of care experience typical chronic care management received by Medicare patients.
Primary Outcome Measure Information:
Title
Hospitalizations
Description
Number of hospitalizations during the 90 day observation period
Time Frame
Baseline and Day 90
Title
Emergency Department Visits
Description
Emergency Department Visits, defined as Mean Number of visits over the 90 day observation period
Time Frame
Days 0-90
Secondary Outcome Measure Information:
Title
Quality of Life
Description
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)
Time Frame
Baseline and Day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renee Pekmezaris, PhD
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nassau University Medical Center
City
East Meadow
State/Province
New York
ZIP/Postal Code
11554
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27343060
Citation
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.
Results Reference
derived

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Telehealth Management in HF Disparity Patients

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