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

NCT00802152 | Completed

• 1 other identifier: 1095618
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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 remote data transmission from in-home devices (blood glucose meter/blood pressure machine) to the clinic on treatment outcomes in patients with diabetes who have out of range blood glucose (BG) or systolic blood pressure (BP) measurements. We test whether the short-term targeted use of in-home monitoring devices facilitates management for providers and improves outcome measures for patients.

Conditions

Hypertension; Diabetes

Keywords

Diabetes; Hypertension

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c (HbA1c) or Systolic blood pressure (SBP)

  Baseline, 3 months

Secondary Outcomes (2)

• Changes in care (process), abstracted from patient's medical record

  3 months, 6 months following enrollment

• Patient-entered device data

  All data over three months

Study Arms (2)

Home Monitoring

EXPERIMENTAL

100 eligible subjects identified as (HbA1c \>= 8% OR SBP \> 130 mm Hg)

Other: Home monitoring

Usual Care

NO INTERVENTION

100 eligible subjects identified as (HbA1c \>= 8% OR SBP \> 130 mm Hg)

Interventions

Home monitoring OTHER

The subject will take their blood pressure or glucose measurements 1-4 times per day, depending on patient condition. They will upload these measurements using the device to a secure website at least every other day. 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).

Also known as: MetrikLink, MediCompass, iMetrikus

Home Monitoring

Eligibility Criteria

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

You may qualify if:

• hemoglobin A1c (A1c) ≥8% OR systolic BP\> 130 on last measurement
• on oral medication or insulin
• Type 2 diabetes
• Diabetes and hypertension for at least one year
• using/owns a blood glucose meter (that is compatible with study equipment)
• followed by an attending MD
• private land phone line or computer with internet connection
• enrolled at Family \& Community Medicine (FCM) Green Meadows , FCM Woodrail or Fairview General Internal Medicine (GIM) clinic and anticipate receiving primary care for next 12 months from MU primary care

You may not qualify if:

• newly diagnosed or Type 1 diabetes
• legally blind
• currently reside in a long-term care facility, including assisted living facility, residential care
• severe cognitive impairment (6-item cognitive screen via recruitment telephone call)
• family/household member enrolled in study

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

University of Missouri, Dept. of Family and Community Medicine

Columbia, Missouri, 65211, United States

Location

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus

Interventions

Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Study Officials

• David Mehr, MD

  University of Missouri, School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2008
• First Posted: December 4, 2008
• Study Start: May 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: June 1, 2011
• Last Updated: June 15, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)