Effect of Care Management on Diabetes Outcomes

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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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Minneapolis Veterans Affairs Medical Center

Minneapolis, Minnesota, 55417, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Case management

Other

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

Primary outcomes

Combined outcome of BP<130/80 mmHG, HgbA1C<8%, and LDL<100mg/dl at 1 year; the primary analysis will compare the intervention to usual care with respect to the percentage of diabetic individuals achieving all three therapeutic goals

Time frame: one year

Secondary outcomes

Safety of the intervention (occurence of adverse events over the course of the trial)

Time frame: one year

Sponsors and collaborators

Lead sponsor

Minneapolis Veterans Affairs Medical Center

Fed

Registry information

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2009
First posted: Dec 7, 2007
Registry last updated: Jun 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed