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Telehealth Management in HF Disparity Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02196922
Enrollment
104
Registered
2014-07-22
Start date
2014-01-01
Completion date
2017-04-30
Last updated
2017-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Heart Failure

Keywords

Chronic Heart Failure, Telehealth, Self Management

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: 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.

Interventions

DEVICETelehealth 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.

OTHERStandard of Care

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

Sponsors

Northwell Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Masking description

Open label

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frameDescription
HospitalizationsBaseline and Day 90Number of hospitalizations during the 90 day observation period
Emergency Department VisitsDays 0-90Emergency Department Visits, defined as Mean Number of visits over the 90 day observation period

Secondary

MeasureTime frameDescription
Quality of LifeBaseline and Day 90Minnesota 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)

Countries

United States

Participant flow

Participants by arm

ArmCount
Comprehensive Outpatient Management (COM)
Patients in the control group will receive COM at a Heart Failure clinic (primary and cardiac care as reimbursed by Medicaid, Medicare or sliding scale/uncompensated care). COM patients will be contacted on a weekly basis in order to maintain comparable frequency of contact. COM: COM experience typical chronic care management received by disparity patients I a heart failure clinic.
58
Telehealth Self Management (TSM)
Telehealth Self Management (TSM): Experimental 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 to the provider station.
46
Total104

Baseline characteristics

CharacteristicComprehensive Outpatient Management (COM)TotalTelehealth Self Management (TSM)
Age, Continuous61.1 years
STANDARD_DEVIATION 15
59.9 years
STANDARD_DEVIATION 15.1
58.4 years
STANDARD_DEVIATION 15.2
Ethnicity (NIH/OMB)
Hispanic or Latino
17 Participants32 Participants15 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
41 Participants72 Participants31 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
41 Participants72 Participants31 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
17 Participants32 Participants15 Participants
Region of Enrollment
United States
58 participants104 participants46 participants
Sex: Female, Male
Female
23 Participants43 Participants20 Participants
Sex: Female, Male
Male
35 Participants61 Participants26 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 581 / 46
other
Total, other adverse events
0 / 580 / 46
serious
Total, serious adverse events
0 / 580 / 46

Outcome results

Primary

Emergency Department Visits

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

Time frame: Days 0-90

Population: Intention to Treat population (all participants to COM or TSM)

ArmMeasureValue (MEAN)Dispersion
Comprehensive Outpatient Management (COM)Emergency Department Visits.69 participants group mean ED visits/90 dayStandard Deviation 0.99
Telehealth Self Management (TSM)Emergency Department Visits.63 participants group mean ED visits/90 dayStandard Deviation 1.18
Primary

Hospitalizations

Number of hospitalizations during the 90 day observation period

Time frame: Baseline and Day 90

Population: Intention to treat population (all participants who are randomized to either COM or TSM.

ArmMeasureValue (MEAN)Dispersion
Comprehensive Outpatient Management (COM)Hospitalizations.55 participant mean hospitalizations/90 dayStandard Deviation 0.9
Telehealth Self Management (TSM)Hospitalizations.78 participant mean hospitalizations/90 dayStandard Deviation 1.3
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)

Time frame: Baseline and Day 90

ArmMeasureValue (MEAN)
Comprehensive Outpatient Management (COM)Quality of Life27.8 units on a scale
Telehealth Self Management (TSM)Quality of Life36.3 units on a scale

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026