Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Telehome Monitoring for Chronic Disease Management

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.
 
ClinicalTrials.gov Identifier: NCT02035566
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : January 14, 2014
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Claudia Baquet, MD, MPH, University of Maryland, College Park

Tracking Information
First Submitted Date  ICMJE January 16, 2013
First Posted Date  ICMJE January 14, 2014
Last Update Posted Date January 14, 2014
Study Start Date  ICMJE February 2011
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2014)
  • Quality of life [ Time Frame: The Outcome Measure(s) are assessing a change from Baseline and 90-day post-baseline ]
    Assessing change from baseline to 90 day evaluated.
  • Number of emergency department visits [ Time Frame: The Outcome Measure(s) are assessing a change from Baseline and 90-day post-baseline ]
    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 [ Time Frame: Assessing change from baseline and 90-day post-baseline ]
    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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2014)
  • Number of contacts (visits or phone calls) with health care providers [ Time Frame: Assessing change from baseline and 90-day post-baseline ]
  • Adequacy of hypertension control [ Time Frame: Measures change from baseline and 90-day post-baseline ]
    Measures change from baseline to 90 day post baseline for:adequacy of blood pressure control (<140/90 mmHg)
  • Adequacy of diabetes control [ Time Frame: Measures change from baseline and 90-day post-baseline ]
    adequacy of glycemic control of HbA1C of <7.5
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Telehome Monitoring for Chronic Disease Management
Official Title  ICMJE Effectiveness of Telehome Monitoring on Quality of Life and Health Resources Utilization Among People With Chronic Disease Residing in Rural Maryland
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Heart Failure
  • Pulmonary Disease, Chronic Obstructive
  • Hypertension
  • Diabetes Mellitus
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Telehome Care Monitoring + Usual Care
    Intervention: Other: Telehome Care Monitoring
  • No Intervention: Usual Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2014)
23
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02035566
Other Study ID Numbers  ICMJE HP-00044150
RC2MD004800 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Claudia Baquet, MD, MPH, University of Maryland, College Park
Study Sponsor  ICMJE University of Maryland, College Park
Collaborators  ICMJE National Institute on Minority Health and Health Disparities (NIMHD)
Investigators  ICMJE
Principal Investigator: Claudia R Baquet, MD MPH University of Maryland, College Park
PRS Account University of Maryland, Baltimore
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP