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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Behavioral: case management with telemonitoring
* Behavioral: usual case management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemonitoring<br>Case management with home telemonitoring for blood sugar and blood pressure plus home HbA1c measurement | Behavioral: case management with telemonitoring<br>* telephone contact with a case manager, home telemonitoring equipment for blood sugar and blood pressure, home HbA1c measurement<br>|
| Active Comparator: Usual case management<br>Case management | Behavioral: usual case management<br>* telephone contact with a case manager<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control (HbA1c) |  | 9 months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure control in patients with elevated blood pressure at baseline |  | 9 months after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes mellitus, chronic care, case management, telemedicine