Telehome Monitoring for Chronic Disease Management
Primary Purpose
Heart Failure, Pulmonary Disease, Chronic Obstructive, Hypertension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telehome Care Monitoring
Sponsored by
About this trial
This is an interventional supportive care trial for Heart Failure focused on measuring Minority Health, Health Status Disparities, Health Care Disparities, Rural Health, Telemedicine, Health Services Research, Social Determinants of Health, Ecological Theory of Health
Eligibility Criteria
Inclusion Criteria:
- Home bound at a home health agency (i.e., Garrett County Health Department Home Health Agency or Chesapeake-Potomac Home Health Agency)
- Clinical diagnosis of at least one of the following: chronic obstructive pulmonary disease, chronic heart failure, uncontrolled hypertension, diabetes mellitus and taking anti-hyperglycemic oral therapy
- Able to operate the telehome care system
- Agreeable to have the telehome care system installed at residence for 60 days
- Residing in an environment where care can be provided safely
Exclusion Criteria:
- Not eligible for home health care
- With a clinical diagnosis of a medical condition other than obstructive pulmonary disease, chronic heart failure, uncontrolled hypertension, diabetes mellitus and taking anti-hyperglycemic oral therapy
- Unable to follow instructions about or be able to operate the telehome care system
- Residing in an environment that is unsafe to provide home health care
Sites / Locations
- Chesapeake-Potomac Home Health Agency
- Garrett County Health Department Home Health Agency
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Telehome Care Monitoring + Usual Care
Usual Care
Arm Description
Outcomes
Primary Outcome Measures
Self reported Quality of life
Assessing change from baseline to 90 day evaluated.
Number of emergency department visits
Assessing change from baseline to 90 day post baseline for:
exacerbation of a recent or remote diagnosis of chronic heart failure (post-baseline) requiring emergency department visit
exacerbation of chronic obstructive pulmonary disease (post-baseline) requiring emergency department visit
episodes of uncontrolled hypo/hyperglycemia (post-baseline) requiring emergency department visit
episodes of severe hypertension (post-baseline) requiring emergency department visit
Re-hospitalization
Assessing change from baseline to 90 day post baseline for:
exacerbation of a recent or remote diagnosis of chronic heart failure (post-baseline) requiring hospital management
exacerbation of chronic obstructive pulmonary disease (post-baseline)requiring hospital management
episodes of uncontrolled hypo/hyperglycemia requiring emergency hospital management
episodes of severe hypertension requiring hospital management
Secondary Outcome Measures
Number of contacts (visits or phone calls) with health care providers
Adequacy of hypertension control
Measures change from baseline to 90 day post baseline for:adequacy of blood pressure control (<140/90 mmHg)
Adequacy of diabetes control
adequacy of glycemic control of HbA1C of <7.5
Compliance with recommended (by discharging physician/primary health professional) drug therapy use for heart failure
Full Information
NCT ID
NCT02035566
First Posted
January 16, 2013
Last Updated
January 12, 2022
Sponsor
University of Maryland, Baltimore
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
1. Study Identification
Unique Protocol Identification Number
NCT02035566
Brief Title
Telehome Monitoring for Chronic Disease Management
Official Title
Effectiveness of Telehome Monitoring on Quality of Life and Health Resources Utilization Among People With Chronic Disease Residing in Rural Maryland
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
People living in rural areas are at increased risk for poor health outcomes due to: long distance to health care facilities, less available health care resources such as primary care and specialty services, transportation problems, higher elderly population, poverty, high uninsured rates and the lack of timely access to new technologies. Called Telehome Care (THC), in the form of equipment in the home, may provide an innovative and potentially cost-effective solution to enhancing chronic disease management services using technology and may influence the reduction in emergency department (ED) visits and hospitalizations in rural areas. However, telehealth research is still in its infancy, it is not well understood, and is often done without an overarching scientific framework. The provision of in home health monitoring and health education also may be a potential population based health research tool for chronically ill patients. Demonstration of the possible benefits, patient acceptance and satisfaction with THC requires a scientific approach as is used in this study.
Detailed Description
While the nation's overall health status has improved over the past decade, disparities persist among racial/ethnic minorities, low-income whites, the medically under-served, and rural residents. The disparities in disease morbidity and mortality are a compelling crisis and the elimination of such disparities is a national priority. With an aging population, the changing demographics are increasing the disease burden attributable to chronic diseases.
The broad goal of this project is to evaluate the potential value of using THC technology in chronically ill patients in rural Maryland, within the broad context of social determinants of health. This builds upon a completed pilot research study in Garrett County on a small scale THC program in rural Garrett County Maryland funded by the Maryland Cigarette Restitution Fund (CRF) supported Other Tobacco Related Diseases (OTRD grant) (CBaquet PI) in collaboration with the division of cardiology and department of family medicine. This research study will look at whether the THC equipment in the home for 60 days will make a difference in the health of the patients who get the unit in their home compared to the patients who will not receive the unit for 60 days. And we will look at whether this technology will support patient monitoring in the home. The use of the technology will be evaluated to determine whether patient monitoring using THC equipment will influence the hospitalization rates or emergency department visits for the patients. Evaluation of the influence of the THC equipment on medical resource utilization in rural and medically underserved communities will be studied.
Telehome care (THC) may provide augmentation to current face to face monitoring through home visits (usual method for Center for Medicaid and Medicare Services (CMS) billable home health services) of chronically ill patients and may provide an innovative and potentially cost-effective solution to improving patients' outcomes and health care resource utilization in rural areas. THC can support the coordination of care by assessing and monitoring patients in their homes and giving health care providers appropriate feedback to assure patient compliance with discharge instructions such as medication, home care and other aspects of recommended treatment regimens. Further, THC may improve service coordination at discharge and provide ongoing monitoring/engagement of patients, which is considered essential to prevent re-hospitalizations and emergency department visits. Demonstration of the potential benefits on care pathways, and patient and provider acceptance and satisfaction with the technology requires systematic larger scale and scientifically rigorous studies.
Purpose The project's broad goals are to evaluate the effects of telehome care (THC), a form of remote patient home monitoring,(within the broad context of social determinants of health) for chronic disease management among rural residing minority, low-income white, and medically underserved patients by: (a) providing an innovative telehome care (THC) capacity and infrastructure in two Maryland rural and medically underserved communities; and (b) using the THC infrastructure to generate scientifically rigorous and high quality evidence on whether the THC technology improves patient monitoring, influences clinical outcomes, and has an impact on medical resource utilization. [NOTE: THC uses telecommunication technologies to enable home health agency clinical staff at a rural home health agency to monitor their patients in the home.]
The major aim for this study are: 1) To evaluate the impact of the 60-day in home THC monitoring on medical resource utilization (emergency department visits; re-hospitalization rates) and Quality of Life related to the management of Metabolic Syndrome/Diabetes Mellitus (DM), Chronic Heart Failure (CHF), Hypertension (HTN), and Chronic Obstructive Pulmonary Disease (COPD) compared to those patients that receive only an educational pamphlet. Secondary aim hopes to support patient education to enhance acceptability, patient independence and satisfaction.
In this study, remote in-home patient monitoring using a THC system from VitelNet (telehealth equipment vendor) will provide patient monitoring remotely or non billable services for the experimental study arm for this project in addition to routine billable home health services. This project does not substitute billable in-home monitoring of patients which is a prerequisite for enrollment into this study(conventional home health services) but provides remote monitoring for the study arm in addition to conventional/billable services delivered.
Patients are randomized to either THC use for 60 days with 60, 90 day follow up or "usual care" with 60, 90 day follow up.
In addition, new knowledge will be generated by this study on methods for conduct of health disparities research and training of non-research clinical personnel who are community based in data collection and research ethics.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Pulmonary Disease, Chronic Obstructive, Hypertension, Diabetes Mellitus
Keywords
Minority Health, Health Status Disparities, Health Care Disparities, Rural Health, Telemedicine, Health Services Research, Social Determinants of Health, Ecological Theory of Health
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telehome Care Monitoring + Usual Care
Arm Type
Experimental
Arm Title
Usual Care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Telehome Care Monitoring
Intervention Description
Telehome care monitoring over a 60-day period wherein patients transmit health measurements to their health care professional on a daily basis
Primary Outcome Measure Information:
Title
Self reported Quality of life
Description
Assessing change from baseline to 90 day evaluated.
Time Frame
The Outcome Measure(s) are assessing a change from Baseline and 90-day post-baseline
Title
Number of emergency department visits
Description
Assessing change from baseline to 90 day post baseline for:
exacerbation of a recent or remote diagnosis of chronic heart failure (post-baseline) requiring emergency department visit
exacerbation of chronic obstructive pulmonary disease (post-baseline) requiring emergency department visit
episodes of uncontrolled hypo/hyperglycemia (post-baseline) requiring emergency department visit
episodes of severe hypertension (post-baseline) requiring emergency department visit
Time Frame
The Outcome Measure(s) are assessing a change from Baseline and 90-day post-baseline
Title
Re-hospitalization
Description
Assessing change from baseline to 90 day post baseline for:
exacerbation of a recent or remote diagnosis of chronic heart failure (post-baseline) requiring hospital management
exacerbation of chronic obstructive pulmonary disease (post-baseline)requiring hospital management
episodes of uncontrolled hypo/hyperglycemia requiring emergency hospital management
episodes of severe hypertension requiring hospital management
Time Frame
Assessing change from baseline and 90-day post-baseline
Secondary Outcome Measure Information:
Title
Number of contacts (visits or phone calls) with health care providers
Time Frame
Assessing change from baseline and 90-day post-baseline
Title
Adequacy of hypertension control
Description
Measures change from baseline to 90 day post baseline for:adequacy of blood pressure control (<140/90 mmHg)
Time Frame
Measures change from baseline and 90-day post-baseline
Title
Adequacy of diabetes control
Description
adequacy of glycemic control of HbA1C of <7.5
Time Frame
Measures change from baseline and 90-day post-baseline
Title
Compliance with recommended (by discharging physician/primary health professional) drug therapy use for heart failure
Time Frame
Assessing change from baseline and 90-day post-baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Home bound at a home health agency (i.e., Garrett County Health Department Home Health Agency or Chesapeake-Potomac Home Health Agency)
Clinical diagnosis of at least one of the following: chronic obstructive pulmonary disease, chronic heart failure, uncontrolled hypertension, diabetes mellitus and taking anti-hyperglycemic oral therapy
Able to operate the telehome care system
Agreeable to have the telehome care system installed at residence for 60 days
Residing in an environment where care can be provided safely
Exclusion Criteria:
Not eligible for home health care
With a clinical diagnosis of a medical condition other than obstructive pulmonary disease, chronic heart failure, uncontrolled hypertension, diabetes mellitus and taking anti-hyperglycemic oral therapy
Unable to follow instructions about or be able to operate the telehome care system
Residing in an environment that is unsafe to provide home health care
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia R Baquet, MD MPH
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chesapeake-Potomac Home Health Agency
City
Hughesville
State/Province
Maryland
ZIP/Postal Code
20637
Country
United States
Facility Name
Garrett County Health Department Home Health Agency
City
Oakland
State/Province
Maryland
ZIP/Postal Code
21550
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Telehome Monitoring for Chronic Disease Management
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