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

NCT00935441 | Completed

• 1 other identifier: 4127-B
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus

Keywords

Diabetes mellitus; chronic care; case management; telemedicine

Outcome Measures

Primary Outcomes (1)

• Glycemic control (HbA1c)

  9 months after enrollment

Secondary Outcomes (1)

• Systolic blood pressure control in patients with elevated blood pressure at baseline

  9 months after enrollment

Study Arms (2)

Telemonitoring

EXPERIMENTAL

Case management with home telemonitoring for blood sugar and blood pressure plus home HbA1c measurement

Behavioral: case management with telemonitoring

Usual case management

ACTIVE COMPARATOR

Case management

Behavioral: usual case management

Interventions

case management with telemonitoring BEHAVIORAL

telephone contact with a case manager, home telemonitoring equipment for blood sugar and blood pressure, home HbA1c measurement

Telemonitoring

usual case management BEHAVIORAL

telephone contact with a case manager

Usual case management

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Minneapolis Veterans Affairs Medical Center: lead

Study Sites (1)

Minneapolis VAMC

Minneapolis, Minnesota, 55417, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Case Management

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 8, 2009
• First Posted: July 9, 2009
• Study Start: June 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 16, 2011

Record last verified: 2011-09

Locations

US (1)