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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 Transtheoreticalstage-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.
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.
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.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
stage-matched intervention, framing effects intervention, attention placebo intervention
VA New York Harbor Healthcare System, NY and BK Campuses
Narrows Institute for Biomedical Research
Published on BioPortfolio: 2014-08-27T03:16:52-0400
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A study in which observations are made before and after an intervention, both in a group that receives the intervention and in a control group that does not.
A study that uses observations at multiple time points before and after an intervention (the "interruption"), in an attempt to detect whether the intervention has had an effect significantly greater than any underlying trend over time.
Procedures and programs that facilitate the development or skill acquisition in infants and young children who have disabilities, who are at risk for developing disabilities, or who are gifted. It includes programs that are designed to prevent handicapping conditions in infants and young children and family-centered programs designed to affect the functioning of infants and children with special needs. (From Journal of Early Intervention, Editorial, 1989, vol. 13, no. 1, p. 3; A Discursive Dictionary of Health Care, prepared for the U.S. House of Representatives Committee on Interstate and Foreign Commerce, 1976)
Situations or conditions requiring immediate intervention to avoid serious adverse results.
Narrowing of the caliber of the BRONCHI, physiologically or as a result of pharmacological intervention.