The prevalence of diabetes among veterans in the VA health system is more than 20% and is double that of the general population. Patients with diabetes are at increased risk for macro and micro vascular complications which are dependant on glycemic control. Control of diabetes depends to a large extent on patient self care behaviors. Apathy is a common behavioral problem characterized by loss of initiative, poor motivation and persistence. Presence of apathy impairs self-care behavior in diabetes patients. Lack of novelty might impair a patient's ability to seek new interactions, life styles and new treatment options for diabetes. Lack of motivation might decrease a patient's ability to initiate exercise, diet and other lifestyle changes, whereas lack of persistence impairs the compliance with these regimens. Thus, apathy influences all stages of self-care. Apathy could also influence patient compliance to diabetes medications. Together this could result in poor control of diabetes and increased complications. Treating apathy might therefore improve adherence to medical regimens and self care behaviors resulting in better diabetes outcomes Hypothesis:Our hypothesis is that pharmacological treatment of apathy will improve glycemic control for patients with poorly controlled diabetes.
Specific Aim 1 : Evaluate if methylphenidate treatment of apathy improves glycemic control in patients with poorly controlled diabetes.
Specific Aim 2 : Determine if methylphenidate improves patient motivation and adherence to diabetes self-care behavior. Project Design and Methods: Study Design: This is a prospective randomized double blind placebo-controlled study. Study duration will be 6 months. Patients with poorly controlled diabetes (A1c>8) and clinically significant apathy (AES >30) will be randomized to either treatment with methylphenidate or placebo. Details of dosing strength and duration are given in the proposal. The primary outcome measure will be change in HbA1c. Secondary outcome measures include those in specific Aim 2 and are PAM, sub-domains of AES and SCI. Potential Impact on Veterans health care: About 20% of veterans have diabetes. Complications of diabetes increase mortality and morbidity greatly. Apathy is very prevalent in the veteran population. Apathy may lead to decreased compliance to medication and impair self care behaviors. Treating apathy may therefore improve motivation and persistence thereby improving compliance and self care behavior. This would lead to better outcomes in diabetes patients in the VA.

Public Health Relevance

Narrative-Significance of the proposed research; Over 20% of veteran patients have diabetes. The incidence of diabetes is expected to increase at an alarming rate over the next decade, in tandem with the increase in the incidence of obesity and the relative aging of the population. Patients with diabetes have a 2-4 fold risk of cardiovascular complications when compared to patients without diabetes. In spite of considerable advances in diabetes management, less than 10% of patients are at goal. Factors that effect adequate implementation of diabetes management regimens need to be studied. Apathy may be one of these factors since apathy leads to a loss of motivation and persistence. Treating apathy may lead to increased adherence to management regimens thus leading to better outcomes in diabetes.

Agency
National Institute of Health (NIH)
Institute
Veterans Affairs (VA)
Type
Non-HHS Research Projects (I01)
Project #
5I01CX000142-02
Application #
7783850
Study Section
Clinical Trials (CLIN)
Project Start
2009-04-01
Project End
2012-06-30
Budget Start
2010-04-01
Budget End
2011-06-30
Support Year
2
Fiscal Year
2011
Total Cost
Indirect Cost
Name
Omaha VA Medical Center
Department
Type
DUNS #
844360367
City
Omaha
State
NE
Country
United States
Zip Code
68105