Telehome Monitoring for Chronic Disease Management

NCT02035566 | Completed

• 2 other identifiers: HP-00044150RC2MD004800
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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 and 90-day post-baseline

• Adequacy of diabetes control

  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

Study Arms (2)

Telehome Care Monitoring + Usual Care

EXPERIMENTAL

Other: Telehome Care Monitoring

Usual Care

NO INTERVENTION

Interventions

Telehome Care Monitoring OTHER

Telehome care monitoring over a 60-day period wherein patients transmit health measurements to their health care professional on a daily basis

Telehome Care Monitoring + Usual Care

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (2)

Chesapeake-Potomac Home Health Agency

Hughesville, Maryland, 20637, United States

Location

Garrett County Health Department Home Health Agency

Oakland, Maryland, 21550, United States

Location

MeSH Terms

Conditions

Heart Failure; Pulmonary Disease, Chronic Obstructive; Hypertension; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Claudia R Baquet, MD MPH

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean and Professor Medicine

Study Record Dates

• First Submitted: January 16, 2013
• First Posted: January 14, 2014
• Study Start: February 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: January 27, 2022

Record last verified: 2022-01

Locations

US (2)