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

Completed · Not applicable · Has a placebo group

Conditions studied: Hypercholesterolemia

In brief

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.

Key facts

Study ID

NCT01043354

Run by

Narrows Institute for Biomedical Research

People needed

247

Starts

2008-09-01

Expected to finish

2012-06-01

Last updated by the study team

2014-04-02

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults with diabetes
• LDL greater than or equal to 100
• Cholesterol-lowering drug therapy for > 6 months
• A working telephone
• At least 2 primary care visits in the past 1.5 years

You may not qualify if…

• Poor short-term survival (< 1 year)
• Inability to understand English
• Recent major surgery (< 3 months)
• Patients temporarily in the area
• Inability to provide consent

Where it is running

• VA New York Harbor Healthcare System, NY and BK Campuses — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.