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Effect of Case-Management Using Home Monitoring on Diabetes and Blood Pressure Outcomes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00935441
First Posted: July 9, 2009
Last Update Posted: September 16, 2011
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.
Information provided by (Responsible Party):
Nacide Ercan-Fang, Minneapolis Veterans Affairs Medical Center
  Purpose
This is a randomized trial designed to determine if adoption of the chronic care model in conjunction with nurse case management, home telemonitoring, and home HbA1c monitoring can improve glycemic control compared to patients receiving usual case management. We hypothesize that nurse case management, with home telemonitoring of blood sugars and home HbA1c measurement will result in additional improvements in glycemic control compared to isolated nurse case management. Specifically, the telemonitoring group will have an HbA1c 0.5% lower compared to usual nurse case management. Secondary aims include an additional 5 mmHg improvement in systolic blood pressure (among patients with hypertension at the time of enrollment), improved patient satisfaction with treatment, improved medication adherence, reduced incidence of hypoglycemia, and reduced case manager time in the telemonitoring/home HbA1c group compared with usual caes management. The study will enroll 460 diabetic patients with HbA1c values greater than 8.5%, age 75 years or younger, who have a active land-line for telephone communication. Patients will be enrolled and actively case managed for 9 months.

Condition Intervention
Diabetes Mellitus Behavioral: case management with telemonitoring Behavioral: usual case management

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Nurse-Based, Protocol-Driven, Case-Management Utilizing Home Telemonitoring and Home HbA1c Measurement on Diabetes and Blood Pressure Outcomes

Further study details as provided by Nacide Ercan-Fang, Minneapolis Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Glycemic control (HbA1c) [ Time Frame: 9 months after enrollment ]

Secondary Outcome Measures:
  • Systolic blood pressure control in patients with elevated blood pressure at baseline [ Time Frame: 9 months after enrollment ]

Estimated Enrollment: 460
Study Start Date: June 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telemonitoring
Case management with home telemonitoring for blood sugar and blood pressure plus home HbA1c measurement
Behavioral: case management with telemonitoring
telephone contact with a case manager, home telemonitoring equipment for blood sugar and blood pressure, home HbA1c measurement
Active Comparator: Usual case management
Case management
Behavioral: usual case management
telephone contact with a case manager

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Enrolled at Minneapolis VAMC,
  • Type 1 or 2 Diabetes,
  • HbA1c >8.5%,
  • active land-line telephone connection

Exclusion Criteria:

  • Age >75 years,
  • primary care provider unwilling to have patient enrolled,
  • active dialysis,
  • resident of assisted living facility,
  • research participant in previous diabetes case management study,
  • life expectancy <1 year,
  • severe mental health condition,
  • active substance abuse,
  • pregnant or planning on becoming pregnant
  Contacts and Locations
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): NCT00935441


Locations
United States, Minnesota
Minneapolis VAMC
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
Minneapolis Veterans Affairs Medical Center
  More Information

Responsible Party: Nacide Ercan-Fang, Principal Investigator, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT00935441     History of Changes
Other Study ID Numbers: 4127-B
First Submitted: July 8, 2009
First Posted: July 9, 2009
Last Update Posted: September 16, 2011
Last Verified: September 2011

Keywords provided by Nacide Ercan-Fang, Minneapolis Veterans Affairs Medical Center:
Diabetes mellitus
chronic care
case management
telemedicine

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases