Effect of Care Management on Diabetes Outcomes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

550 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2009-05-31

Brief Summary

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The purpose of the study is to determine if a nurse managed, protocol driven, disease management process for diabetes results in improved attainment of therapeutic goals for diabetes compared to usual care. It is hypothesized that implementation of the disease management process will improve the percentage of diabetic individuals attaining all three therapeutic targets (HgbA1C\<8.0%, LDL\<100mg/dl, and BP\<130/80mmHG) by 10% compared to usual care.

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Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual Care

Patients receive care through primary care provider

Group Type NO_INTERVENTION

Case Management

Intervention Type OTHER

Phone contact by specially trained nurse case managers; lifestyle recommendations and medication changes as needed

Case Management

Specially trained nurse case managers contact patients by telephone; monitor blood pressure, LDL, and HgbA1C;, and recommend lifestyle and medication changes as needed

Group Type EXPERIMENTAL

Case Management

Intervention Type OTHER

Phone contact by specially trained nurse case managers; lifestyle recommendations and medication changes as needed

Interventions

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Case Management

Phone contact by specially trained nurse case managers; lifestyle recommendations and medication changes as needed

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Enrolled at Minneapolis VAMC
* Type 1 or 2 diabetes
* Blood pressure at screening visit \> 140mmHg systolic or \> 90mmHg diastolic OR HgbA1C at screening visit \> 9.0% OR LDL at screening visit \> 100mg/dL

Exclusion Criteria

* Primary care provider unwilling to have participant included in study
* Life expectancy \< 1 year
* Unable to give consent
* Severe mental health condition
* pregnant or planning on becoming pregnant

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No