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

Not Applicable

Completed

• Conditions: Hypercholesterolemia
• Interventions: Behavioral: stage-matched intervention; Behavioral: framing effects intervention; Behavioral: attention placebo intervention

• Registration Number: NCT01043354
• Lead Sponsor: Narrows Institute for Biomedical Research

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2010-01-05
• Study First Submitted QC: 2010-01-05
• Study First Posted: 2010-01-06
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-01
• Last Update Posted: 2014-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 247

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stage-matched intervention	stage-matched intervention	Transtheoretical Model-based stage-matched intervention
framing effects intervention	framing effects intervention	counseling based on prospect theory
attention placebo intervention	attention placebo intervention	counseling about general health topics

Primary Outcome Measures

Name	Time	Method
LDL control	6 months
medication adherence	6 months

Secondary Outcome Measures

Name	Time	Method
diet adherence	6 months
exercise adherence	6 months

Trial Locations

Locations (1)

VA New York Harbor Healthcare System, NY and BK Campuses; 🇺🇸 New York, New York, United States