TACTICS (Targeting Adherence to Cholesterol-lowering Therapy to Improve Control Study)

Background:

This is a randomized controlled trial (RCT) of two novel behavioral interventions to enhance
treatment adherence and improve low-density lipoprotein cholesterol (LDL) in diabetes. Among
adults with diabetes, high LDL greatly increases their risk for cardiovascular disease
(CVD). Despite the proven efficacy of LDL control(<100 mg/dL) in preventing CVD, the control
rate is low. Poor adherence to treatment(diet, exercise and medication) is the main reason
for this poor control.

Aims: This study will test two telephone-delivered interventions, a Transtheoretical
stage-matched intervention (SMI) and a Prospect theory-based framing effects intervention
(FEI). The investigators hypothesize that both SMI and FEI will be more effective in
improving LDL control than an attention placebo intervention (API) at 6 months. SMI and FEI
will also be more effective in increasing adherence to medications, diet and exercise than
API at 6 months.

Methods:

The investigators will recruit 246 adults with diabetes and high LDL despite being on
medications. Key outcomes are adherence to diet, exercise and medication, and LDL control.
The interventions will be standardized and fidelity of intervention maintained. Using a
blinded RCT the investigators will test the effect of SMI and FEI compared to API on LDL
control and adherence. All analyses will be intent to treat.

Significance:

This project will provide important information to improve diabetes-related behavior and
lead to the implementation of novel interventions for lowering LDL in primary care settings
among adults with diabetes. It may also provide the scientific rationale to use such
approaches to control other risk factors in diabetes.