Hypercholesterolemia
Conditions
Keywords
cholesterol, diabetes, adherence
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.
Interventions
BEHAVIORALstage-matched intervention
6 monthly tailored telephone-delivered counseling sessions of transtheoretical model-based counseling
BEHAVIORALframing effects intervention
6 monthly telephone-delivered counseling sessions based on prospect theory
BEHAVIORALattention placebo intervention
6 monthly counseling sessions about general health topics
Sponsors
Narrows Institute for Biomedical Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL control | 6 months |
| medication adherence | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| diet adherence | 6 months |
| exercise adherence | 6 months |
Countries
United States
Outcome results
None listed