Telehome Monitoring for Chronic Disease Management

Effectiveness of Telehome Monitoring on Quality of Life and Health Resources Utilization Among People With Chronic Disease Residing in Rural Maryland

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Hypertension; Diabetes Mellitus; Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Other: Telehome Care Monitoring

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Hughesville, Maryland, United States, 20637
      • Chesapeake-Potomac Home Health Agency
    • Oakland, Maryland, United States, 21550
      • Garrett County Health Department Home Health Agency

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care
Experimental: Telehome Care Monitoring + Usual Care	Other: Telehome Care Monitoring; Telehome care monitoring over a 60-day period wherein patients transmit health measurements to their health care professional on a daily basis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self reported Quality of life	Assessing change from baseline to 90 day evaluated.	The Outcome Measure(s) are assessing a change from Baseline and 90-day post-baseline
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	The Outcome Measure(s) are assessing a change from Baseline and 90-day post-baseline
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	Assessing change from baseline and 90-day post-baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of contacts (visits or phone calls) with health care providers		Assessing change from baseline and 90-day post-baseline
Adequacy of hypertension control	Measures change from baseline to 90 day post baseline for:adequacy of blood pressure control (<140/90 mmHg)	Measures change from baseline and 90-day post-baseline
Adequacy of diabetes control	adequacy of glycemic control of HbA1C of <7.5	Measures change from baseline and 90-day post-baseline
Compliance with recommended (by discharging physician/primary health professional) drug therapy use for heart failure		Assessing change from baseline and 90-day post-baseline

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Claudia R Baquet, MD MPH, University of Maryland School of Medicine

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: January 16, 2013
• First Submitted That Met QC Criteria: January 10, 2014
• First Posted (Estimate): January 14, 2014

Study Record Updates

• Last Update Posted (Actual): January 27, 2022
• Last Update Submitted That Met QC Criteria: January 12, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Telemedicine; Minority Health; Health Services Research; Social Determinants of Health; Rural Health; Health Status Disparities; Health Care Disparities; Ecological Theory of Health
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Chronic Disease
• Other Study ID Numbers: HP-00044150; RC2MD004800 (U.S. NIH Grant/Contract)