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Telehome Monitoring for Chronic Disease Management

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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

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.

Condition or disease Intervention/treatment Phase
Heart Failure Pulmonary Disease, Chronic Obstructive Hypertension Diabetes Mellitus Other: Telehome Care Monitoring Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effectiveness of Telehome Monitoring on Quality of Life and Health Resources Utilization Among People With Chronic Disease Residing in Rural Maryland
Study Start Date : February 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

No Intervention: Usual Care



Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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


Secondary Outcome Measures :
  1. Number of contacts (visits or phone calls) with health care providers [ Time Frame: Assessing change from baseline and 90-day post-baseline ]
  2. 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)

  3. Adequacy of diabetes control [ Time Frame: Measures change from baseline and 90-day post-baseline ]
    adequacy of glycemic control of HbA1C of <7.5

  4. 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 ]


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035566


Locations
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United States, Maryland
Chesapeake-Potomac Home Health Agency
Hughesville, Maryland, United States, 20637
Garrett County Health Department Home Health Agency
Oakland, Maryland, United States, 21550
Sponsors and Collaborators
University of Maryland, College Park
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Claudia R Baquet, MD MPH University of Maryland, College Park
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Responsible Party: Claudia Baquet, MD, MPH, Associate Dean and Professor Medicine, University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT02035566    
Other Study ID Numbers: HP-00044150
RC2MD004800 ( U.S. NIH Grant/Contract )
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: January 2014
Keywords provided by Claudia Baquet, MD, MPH, University of Maryland, College Park:
Minority Health
Health Status Disparities
Health Care Disparities
Rural Health
Telemedicine
Health Services Research
Social Determinants of Health
Ecological Theory of Health
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Chronic Disease
Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive