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

Diabetes Mellitus Clinical Trial

Official title:

Effect of Nurse-Based, Protocol-Driven, Case-Management Utilizing Home Telemonitoring and Home HbA1c Measurement on Diabetes and Blood Pressure Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00935441
• Other study ID #: 4127-B
• Status: Completed
• Phase: N/A
• First received: July 8, 2009
• Last updated: September 14, 2011
• Start date: June 2009
• Est. completion date: September 2011

Study information

• Verified date: September 2011
• Source: Minneapolis Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Behavioral:
• case management with telemonitoring
telephone contact with a case manager, home telemonitoring equipment for blood sugar and blood pressure, home HbA1c measurement
• usual case management
telephone contact with a case manager

Locations

Country	Name	City	State
United States	Minneapolis VAMC	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Minneapolis Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic control (HbA1c)		9 months after enrollment	No
Secondary	Systolic blood pressure control in patients with elevated blood pressure at baseline		9 months after enrollment	No