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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Behavioral: stage-matched intervention
* Behavioral: framing effects intervention
* Behavioral: attention placebo intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stage-matched intervention<br>Transtheoretical Model-based stage-matched intervention | Behavioral: stage-matched intervention<br>* 6 monthly tailored telephone-delivered counseling sessions of transtheoretical model-based counseling<br>|
| Experimental: framing effects intervention<br>counseling based on prospect theory | Behavioral: framing effects intervention<br>* 6 monthly telephone-delivered counseling sessions based on prospect theory<br>|
| Active Comparator: attention placebo intervention<br>counseling about general health topics | Behavioral: attention placebo intervention<br>* 6 monthly counseling sessions about general health topics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL control |  | 6 months | 
| medication adherence |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diet adherence |  | 6 months | 
| exercise adherence |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cholesterol, diabetes, adherence