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

July 8, 2009
September 14, 2011
June 2009
September 2011   (final data collection date for primary outcome measure)
Glycemic control (HbA1c) [ Time Frame: 9 months after enrollment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00935441 on ClinicalTrials.gov Archive Site
Systolic blood pressure control in patients with elevated blood pressure at baseline [ Time Frame: 9 months after enrollment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Case-Management Using Home Monitoring on Diabetes and Blood Pressure Outcomes
Effect of Nurse-Based, Protocol-Driven, Case-Management Utilizing Home Telemonitoring and Home HbA1c Measurement on Diabetes and Blood Pressure Outcomes

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus
  • Behavioral: case management with telemonitoring
    telephone contact with a case manager, home telemonitoring equipment for blood sugar and blood pressure, home HbA1c measurement
  • Behavioral: usual case management
    telephone contact with a case manager
  • Experimental: Telemonitoring
    Case management with home telemonitoring for blood sugar and blood pressure plus home HbA1c measurement
    Intervention: Behavioral: case management with telemonitoring
  • Active Comparator: Usual case management
    Case management
    Intervention: Behavioral: usual case management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
460
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00935441
4127-B
Not Provided
Nacide Ercan-Fang, Minneapolis Veterans Affairs Medical Center
Minneapolis Veterans Affairs Medical Center
Not Provided
Not Provided
Minneapolis Veterans Affairs Medical Center
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP