NCT01043354

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 247 (actual)
• Sponsor: Narrows Institute for Biomedical Research · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
BEHAVIORAL	stage-matched intervention	6 monthly tailored telephone-delivered counseling sessions of transtheoretical model-based counseling
BEHAVIORAL	framing effects intervention	6 monthly telephone-delivered counseling sessions based on prospect theory
BEHAVIORAL	attention placebo intervention	6 monthly counseling sessions about general health topics

Timeline

• Start date: 2008-09-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2010-01-06
• Last updated: 2014-04-02

Locations

1 site across 1 country: United States