Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nacide Ercan-Fang, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00935441
First received: July 8, 2009
Last updated: September 14, 2011
Last verified: September 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Minneapolis Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Glycemic control (HbA1c) [ Time Frame: 9 months after enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Systolic blood pressure control in patients with elevated blood pressure at baseline [ Time Frame: 9 months after enrollment ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00935441

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

No publications provided

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
Study First Received: July 8, 2009
Last Updated: September 14, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on May 23, 2013