Using Health Information Technology (HIT) to Improve Ambulatory Chronic Disease Care: Smart Device Substudy - Full Text View

Sponsors and Collaborators:	University of Missouri-Columbia Agency for Healthcare Research and Quality (AHRQ)
Information provided by:	University of Missouri-Columbia
ClinicalTrials.gov Identifier:	NCT00802152

Purpose

In-home health monitoring devices have the potential to increase the speed and ease of modifying treatment for ambulatory patients living with chronic conditions. This study examines the implementation and effectiveness of in-home health monitoring devices for 1) patients diagnosed with Type 2 Diabetes who currently have uncontrolled blood glucose levels and 2) patients who currently are being assessed for hypertension. We test whether the targeted use of in-home monitoring devices facilitates management for providers and improves outcome measures for patients.

Condition	Intervention	Phase
Hypertension Diabetes	Device: In-home "smart" diagnostic devices	Phase 0

MedlinePlus related topics: Coping with Chronic Illness Diabetes High Blood Pressure

Drug Information available for: Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Using Health Information Technology (HIT) to Improve Ambulatory Chronic Disease Care: Smart Device Substudy

Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:

hemoglobin A1c (HbA1c) [ Time Frame: Baseline and at 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Diagnostic Timeframe (proposed intervention will lessen time to diagnose) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Systolic Blood Pressure [ Time Frame: daily for 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	400
Study Start Date:	December 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: HBP Intervention: Experimental 100 eligible subjects identified as (SBP > 130 mm Hg)	Device: In-home "smart" diagnostic devices The subject will enter information about their blood pressure or glucose measurements into the device from 1-4 times per day depending on patient condition and send the information by telephone to either the Family Medicine Clinic or General Internal Medicine Clinic. Data will be uploaded at least daily, and up to 4 times daily. Data will be reviewed at least 2 times per week Monday through Friday by the clinic nursing staff. Data indicating problems, e.g., critical out of range values, will be communicated to the patient's primary care physician after review by the nurse. The physician will then determine what is needed for follow up action based on the patient's condition and data (e.g., telephone call to patient home, scheduling a clinic appointment, etc).
2: High Blood Sugar: Experimental 100 patients identified as having hemoglobin A1c > 8%	Device: In-home "smart" diagnostic devices The subject will enter information about their blood pressure or glucose measurements into the device from 1-4 times per day depending on patient condition and send the information by telephone to either the Family Medicine Clinic or General Internal Medicine Clinic. Data will be uploaded at least daily, and up to 4 times daily. Data will be reviewed at least 2 times per week Monday through Friday by the clinic nursing staff. Data indicating problems, e.g., critical out of range values, will be communicated to the patient's primary care physician after review by the nurse. The physician will then determine what is needed for follow up action based on the patient's condition and data (e.g., telephone call to patient home, scheduling a clinic appointment, etc).
1b HBP Control: No Intervention 100 eligible subjects identified as (SBP > 130 mm Hg)
2b HBS Control: No Intervention 100 patients identified as having hemoglobin A1c > 8%

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Hemoglobin A1c >8% or systolic blood pressure > 130mm Hg

Exclusion Criteria:

legally blind
currently living in long term care facility
have no telephone line in home
do not speak English
have severe cognitive impairment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00802152

Contacts

Contact: Bonnie Wakefield, PhD

573-882-0221

wakefieldb@missouri.edu

Locations

United States, Missouri
University of Missouri, Dept. of Family and Community Medicine
Columbia, Missouri, United States, 65211

Sponsors and Collaborators

University of Missouri-Columbia

Agency for Healthcare Research and Quality (AHRQ)

Investigators

Principal Investigator:

David Mehr, MD

University of Missouri, School of Medicine

More Information

Responsible Party:	University of Missouri, School of Medicine ( Dr. David Mehr )
Study ID Numbers:	1095618
Study First Received:	December 2, 2008
Last Updated:	December 3, 2008
ClinicalTrials.gov Identifier:	NCT00802152
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:

Diabetes
Hypertension

Study placed in the following topic categories:

Vascular Diseases
Diabetes Mellitus
Chronic Disease
Hypertension

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009