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

Narrows Institute for Biomedical Research

Status: Completed

Conditions: Hypercholesterolemia

Treatments: Behavioral: attention placebo intervention; Behavioral: framing effects intervention; Behavioral: stage-matched intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01043354

ADA 7-08-CR-68

Details and patient eligibility

About

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.

Enrollment: 247 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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247 participants in 3 patient groups

stage-matched intervention

Experimental group

Description:

Transtheoretical Model-based stage-matched intervention

Treatment:

Behavioral: stage-matched intervention

framing effects intervention

Experimental group

Description:

counseling based on prospect theory

Treatment:

Behavioral: framing effects intervention

attention placebo intervention

Active Comparator group

Description:

counseling about general health topics

Treatment:

Behavioral: attention placebo intervention